Aria Truninger
Vista,CA
Summary
Experienced and versatile pharmaceutical industry professional with a history of exceeding company goals through the development of consistent and organized practices. A performance-oriented and enterprising leader with an organized nature and a solutions-oriented approach. Excels in working under pressure and adapting to new situations and challenges. Skilled in People Management, Customer Relationship Management (CRM), Communication, Commercial and Clinical Pharmaceutical Packaging, KPI dashboards, GMP, and Business Development.
Overview
11
11
years of professional experience
Work History
Director, Global Proposals
PCI Pharma Services, Clinical Services
San Diego, CA
07.2020 - Current
- From 2017 to 2022, supported revenue growth from $400M to $1B
- Led team of 15+ Global team members across United States, Canada, United Kingdom, Europe and Australia
- Lead, developed and managed Global Clinical Proposals team to deliver timely, quality and globally harmonized proposals
- Led proposal development across 21 Clinical packaging and labeling, storage and distribution locations at win rate of 75%
- Led integration and harmonization of estimation practices of acquired company [LSNE] into PCIs proposal development process
- Developed processes, systems and pricing strategy for Aseptic Manufacturing Proposals, including Sterile Fill-Finish and Lyophilization Services
- Works directly with Senior Management across multiple departments of organization to identify, develop and implement methods to improve efficiency and quality of proposals
- Acted as corporate subject matter expert for PCIs Global Clinical Proposals process and business development information request
- Overall management of Global Clinical Proposal team which includes Proposal Managers, Senior Business Development Associates and their direct reports, as well as Business Development Coordinators
- Developed, implemented and managed harmonized processes, pricing tools, systems, pricing strategy and template initiatives across Global Clinical Proposals Team
- Managed and led acquisition strategy associated with integration of PCI Global Proposal processes with LSNE [acquired November 2021]
- Developed Global Clinical Proposal training which includes plans for onboarding of new staff as well as ongoing training of existing staff as well as personnel outside of team (including Project Management and Sales)
- Oversees and directs ongoing quality control process of Global Clinical proposal development and business information (RFI) deliverables
- Supported PCI’s Clinical growth in developing winning strategies to be utilized within proposals for growth and aspirational accounts
- Oversees management and coordination of completion of strategic pricing schedules to ensure contract adherence
- Manages and coordinates global pricing review initiatives with Senior Management and ensures adherence annually
- Works with Proposal team to ensure adherence to Salesforce.com data entry practices
- Generates and coordinates development of Salesforce.com reports through Business Development Coordinator's to assist in corporate reporting
- Reviewed Standard Operating Procedures (SOPs), Working Procedures and Job Descriptions for Global Clinical Proposals Team
- Develops and leads proposal process globalization and strategy initiatives
- Attends bid defenses and other client meetings in supporting role as needed
- Ensures continuous departmental process improvements are implemented and participates in special projects as required.
- Focused teams on developing innovative and cutting-edge approaches with effective resource allocation and strategic planning.
- Created annual budget and developed comprehensive plan to accomplish company objectives while staying within budget
- Developed impactful internal strategic partnerships to drive business development.
- Using Smartsheets, optimized operational processes by developing company-wide analytics tool to address client-specific metrics
- Established performance goals for global department and provided feedback on methods for reaching those milestones.
- Hired and directed teams to achieve daily and long-term operations and business goals
Senior Manager, Global Proposals
PCI Pharma Services, Clinical Services
San Diego, CA
06.2019 - 07.2020
- Led team of twelve associates across the United States, Australia, United Kingdom and Canada producing a high volume of quality clinical packaging and distribution proposals within expected timeframe at a 75% win rate
- Supported Sales by developing Proposals which surpassed global revenue goals by 15%
- Led integration and harmonization of estimation practices of acquired company [Bellwyck Pharma Services] into PCIs proposal development process
- Onboarded and mentored all new Business Development Associate staff to SOPs, clinical supply management, and business development skills
- Translated clinical protocols and RFPs to develop accurate proposals, timelines, and guidance for several Phase 1-3 global clinical studies over multiple packaging campaigns
- Developed and implemented KPI's which drove team accountability and productivity
- Developed and implemented procedures to integrate critical opportunity data into PCI’s CRM platform (Salesforce), creating visibility of service line capacity and pipeline visibility
- Regularly updated Salesforce with outstanding proposal statuses and potential new opportunities, and monitored monthly metrics to cultivate existing and new client relationships
- Developed and instituted a scalable, quality-focused, efficient proposal development process which decreased turnaround time from an average of eight days to four days lead time; increasing client satisfaction and win rates
- Supports Sales and Project Management teams by acting as subject matter expert for setup and scope of awarded projects, allowing for seamless project hand off from Sales to Client and Sales to Operations
- Coordinated innovative strategies to accomplish marketing objectives and boost long-term profitability.
- Developed and implemented favorable pricing structures balancing sales objectives against organization targets
- Incorporated service offerings and marketing messaging into Proposal templates to drive customer engagement and maximize profits
- Completed and submitted monthly and yearly reports to support executive decision making
- Represented company and promoted products at conferences and trade association meetings
- Summarized and presented detailed proposal information in internal management reviews and customer fact-finding meetings.
- Worked collaboratively with departments to increase success with bid opportunities and supported internal initiatives to improve value proposition
Senior Manager, US Proposals
PCI Pharma Services, Clinical Services
Rockford, IL
11.2018 - 06.2019
- Led team of seven associates across the Midwest, West Coast and Australia producing a high volume of quality clinical packaging and distribution proposals within expected timeframe at a 75% win rate
- Led integration and harmonization of estimation practices of acquired companies into PCI [Pharmaceutical Packaging Professionals - March 2018 & Sherpa Clinical Packaging - September 2018]
- Working with programmers from PCIs Customer Relationship Management platform Salesforce.com, developed an automated quoting tool utilized by Proposals team to generate Proposals instantaneously
- Quoting tool reduced Proposal turnaround time from five days to two days
- Onboarded and mentored all new Business Development Associate staff to SOPs, clinical supply management, and business development skills
- Translated clinical protocols and RFPs to develop accurate proposals, timelines, and guidance for several Phase 1-3 global clinical studies over multiple packaging campaigns
- Developed and implemented KPI's which drove team accountability and productivity
- Developed and implemented procedures to integrate critical opportunity data into PCI’s CRM platform (Salesforce), creating visibility of service line capacity and pipeline visibility
- Regularly updated Salesforce with outstanding proposal statuses and potential new opportunities, and monitored monthly metrics to cultivate existing and new client relationships
- Developed and instituted a scalable, quality-focused, efficient proposal development process which decreased turnaround time from an average of eight days to four days lead time; increasing client satisfaction and win rates
- Supports Sales and Project Management teams by acting as subject matter expert for setup and scope of awarded projects, allowing for seamless project hand off from Sales to Client and Sales to Operations
- Coordinated innovative strategies to accomplish marketing objectives and boost long-term profitability.
- Developed and implemented favorable pricing structures balancing sales objectives against organization targets
- Incorporated service offerings and marketing messaging into Proposal templates to drive customer engagement and maximize profits
- Completed and submitted monthly and yearly reports to support executive decision making
- Represented company and promoted products at conferences and trade association meetings
- Summarized and presented detailed proposal information in internal management reviews and customer fact-finding meetings.
- Worked collaboratively with departments to increase success with bid opportunities and supported internal initiatives to improve value proposition
Business Development Manager, US Proposals
PCI Pharma Services – Clinical Services
Rockford, IL
05.2017 - 11.2018
- Formed, developed and led PCI Midwest US Proposals team
- Led, supervised and managed team of four Business Development Associates to produce high quality clinical packaging and distribution proposals within expected timeframe
- Led, supervised and managed team of Business Development Coordinators to capture all Proposal operations data into PCIs CRM, Salesforce.com
- Trained Business Development Coordinators to develop KPI data using Salesforce.com
- Supported quoting operations across PCIs global clinical network of three locations
- Developed and implemented harmonized systems, processes and procedures which were instituted across Global Clinical Sales team
- Onboarded and mentored all new Business Development Associate staff to SOPs, clinical supply management, and business development skills
- Translated clinical protocols and RFPs to develop accurate proposals, timelines, and guidance for several Phase 1-3 global clinical studies over multiple packaging campaigns
- Developed and implemented KPI's which drove team accountability and productivity
- Developed and implemented procedures to integrate critical opportunity data into PCIs CRM platform (Salesforce), creating visibility of service line capacity and pipeline visibility
- Regularly updated Salesforce with outstanding proposal statuses and potential new opportunities, and monitored monthly metrics to cultivate existing and new client relationships
- Developed and instituted a scalable, quality-focused, efficient proposal development process which decreased turnaround time from an average of eight days to four days lead time; increasing client satisfaction and win rates
- Supports Sales and Project Management teams by acting as subject matter expert for setup and scope of awarded projects, allowing for seamless project hand off from Sales to Client and Sales to Operations
- Coordinated innovative strategies to accomplish marketing objectives and boost long-term profitability.
- Developed and implemented favorable pricing structures balancing sales objectives against organization targets
- Incorporated service offerings and marketing messaging into Proposal templates to drive customer engagement and maximize profits
- Completed and submitted monthly and yearly reports to support executive decision making
- Represented company and promoted products at conferences and trade association meetings
- Summarized and presented detailed proposal information in internal management reviews and customer fact-finding meetings.
- Worked collaboratively with departments to increase success with bid opportunities and supported internal initiatives to improve value proposition
Quality Account Manager
PCI Pharma Services, Commercial Services
Rockford, IL
08.2014 - 05.2017
- Planned, directed, and coordinated all Quality activities of designated Customer-Focused Team (CFT). Ensured financial goals of organization and customer objectives were met and within prescribed time frames.
- Successfully lead Customer Focus Team, managing over 20 Customer Accounts with annual revenue of $30 Million in revenue.
- Selected, supervised, empowered, coached, developed, and retained team of eight Quality associates through effective employee development, performance management, succession planning and recognition
- Developed Quality Training program for all new Quality hires across Commercial CFT, improving effectiveness of training and retention of fundamental concepts, reducing rework and mitigating risk of error
- Managed execution of Change Controls, Investigations (Product-Process, OOS Deviations), Consumer Complaints, Annual Product Reviews, Quality Agreements, Customer Specific Metrics, Non-Conforming Material Deviations, developing CAPA’s and completing Effectiveness Reviews, FMEA’s, Validations, Batch Records and Material Specifications
- Facilitated daily quality team performance reviews to drive accountability, track actions, goals, and objectives to completion
- Provided support for customer audits, supplier audits and FDA audits
- Continuously worked to ensure PCI Standard Operating Procedures and work instructions accurately reflected CFR’s/cGMP policies, procedures, rules and regulations.
- Secured high-value accounts through consultative selling, effective customer solutions and promoting compelling business opportunities.
- Liaised between account holders and various departments.
Customer Project Planner
PCI Pharma Services, Commercial Services
Rockford, IL
11.2013 - 08.2014
- Primary customer contact for tactical operational activities, including relationship and customer expectation management matters. Managed day to day packaging production for customer projects, coordinated schedules within supply chain constraints working directly with procurement to ensure timely delivery of required packaging components
- Worked with Clients to establish timelines for production forecasts and bulk deliveries to ensure line capacities, production schedules, timelines, and shipment dates were achievable
- Analyzed customer forecasts against capacity on packaging lines as well as available inventory
- Worked swiftly to ensure proper action was taken to react to constantly changing customer demands
- Managed project planning activities for 35+ Client accounts between 2013 and 2014
- Prepared and distributed project and production updates to Clients and internal Operations teams
- Created work order jackets, managed jacket routing, and issued batch records to Operations team
- Procured component materials to ensure orders were ready for maintenance and production requirements
- Reviewed and approve cGMP documentation including Batch Records, Component and Bulk Specifications, and Lot/Expiration forms for accuracy against material allocated to work order
- Executed ERP system inventory transactions, shipping dispatches, monthly invoicing and job creations
- Implemented various process improvement projects across Operations functional areas such as inventory control, cycle time improvement, and margin increase
- Scheduled and facilitated meetings between project stakeholders to discuss deliverables, schedules and conflicts. Maintained open communication by presenting regular updates on project status to customers.
- Built successful project plans covering objectives, resources and staffing to meet launch timelines
- Exceeded goals through effective task prioritization and great work ethic
- Drove operational improvements which resulted in savings and improved profit margins
Quality Specialist
PCI Pharma Services, Commercial Services
Rockford, IL
01.2013 - 11.2013
- Functioned as Quality Representative customer contact (quality representative) for all Quality related issues for PCIs largest Commercial customer
- Managed development of investigations and CAPAs for 35+ accounts. Achieved Investigation on-time adherence, with 99% OT rate from 2012-2013
- Organized and hosted daily, weekly & Quarterly Quality client-facing review meetings to review PCIs Quality performance
- Acted as liaison between internal and external customers to resolve issues associated with quality events
- Lead technical failure analysis investigations and implemented corrective actions (CAPA) to preclude recurrence
- Effectively resolved issues in timely and quality manner in order to release product pending investigation approval
- Effectively prioritized completing requests for multiple customers to ensure client satisfaction and organizational goals were met
- Provided strong abilities in constructing raw data into understandable and useful information to support defect trending analysis
- Identified gaps in PCI procedures, developed improvements, implemented corrective actions and completed effectiveness reviews
- Presented strong understanding and ability to effectively utilize PCIs ERP, JD Edwards (JDE) and PCIs EDMS
- Developed extensive understanding of cGMP requirements, industry standards and PCI Standard Operating Procedures
- Developed effective protocols and deviation report instructions for operations to utilize in support of continued operations post CAPA
- Effectively identified and determined product impact in defect discoveries and defect events
- Provide responses to all customer-driven requests related to quality issues for 35+ clients
- Aided in internal and external audits
- Successfully investigated issues and determined probable root cause and corrective and preventative actions by working cross-functionally across various departments
- Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies
- Fixed identified issues to increase productivity and boost workflows
- Promoted adherence to quality standards by educating personnel on quality control
- Developed monthly, end-of-quarter and other statistical reports for leadership team and quality improvement programs
- Collaborated with management to provide training on improved processes and assisted with creation and maintenance of quality training
- Collected and analyzed activity data and initiated, developed and recommended improvements to systems, processes and procedures to increase productivity and reduce cost
Quality Engineering Technician
PCI Pharma Services, Commercial Services
Rockford, IL
05.2012 - 01.2013
- Documented quality events within formal investigation reports, which included development of corrective and preventative actions
- Investigated consumer complaints and completed complaint responses.
- Conducted statistical analysis to support trend reviews
- Assisted with external supplier and client-facing audits
- Developed departmental metrics in support of tracking and improving systems utilized within Quality Engineering department
- Functioned as Customer point of contact for complaint investigations for +30 accounts managed within Quality Engineering
- Coordinated training and proficiency of new hires within Quality Engineering team
- Developed training protocols in alignment with company quality standards
- Participated in multi-disciplinary defect reviews to discern and address root causes.
- Performed quality inspections and drafted reports to detail non-conforming material issues.
- Built strong rapport with team members, management and clients to facilitate efficiency and productivity.
- Mapped process workflows to enhance understanding of procedures.
- Evaluated employee performance and equipment organization to assess and improve plant operations.
- Developed automation tools to improve efficiency, eliminate waste and free up labor hours for other needs.
- Contributed to root cause analysis to determine core reason for failures and errors
Quality Control Batch Release Coordinator
PCI Pharma Services, Commercial Services
Rockford, IL
05.2011 - 05.2012
- Performed analytical review of documents to ensure cGMP and CFR requirements were met and followed throughout packaging process
- Prepared and analyzed material accountability reports which reconciled production yields and customer inventories
- Reviewed and resolved document-related issues internally and with customers through excellent written and verbal communication
- Responsible for managing batch record reviews for up to 25 Commercial accounts
- Developed and shared continuous improvement initiatives with Senior Leadership to reduce batch record review times from five to three days
- Provided Senior leadership with metrics to increase effectiveness of meeting customer expectations
- Coordinated and led training initiatives for new hires, developing educational materials to train staff on QA standards. Developed training manual for new hires, resulting in increased knowledge, speed, and effectiveness of training process and department throughput
- Collected and analyzed activity data and initiated, developed, and recommended improvements to systems, processes, and procedures to increase productivity and reduce cost
- Maintained energy and enthusiasm in fast-paced environment
- Identified issues, analyzed information and provided solutions to problems
- Created spreadsheets using Microsoft Excel for daily, weekly and monthly reporting
- Carried out day-day-day duties accurately and efficiently
Education
MBA - Management & Operations
Rockford University
Rockford, IL2014
Bachelor of Science - Business Administration And Management
Rockford University
Rockford, IL05.2011
Skills
- Strategic planning
- Staff Management
- Project Management
- Solutions Provider
- Verbal and written communication
- Business Development
- GMP
- Advanced problem solving
Timeline
Director, Global Proposals
PCI Pharma Services, Clinical Services
07.2020 - Current
Senior Manager, Global Proposals
PCI Pharma Services, Clinical Services
06.2019 - 07.2020
Senior Manager, US Proposals
PCI Pharma Services, Clinical Services
11.2018 - 06.2019
Business Development Manager, US Proposals
PCI Pharma Services – Clinical Services
05.2017 - 11.2018
Quality Account Manager
PCI Pharma Services, Commercial Services
08.2014 - 05.2017
Customer Project Planner
PCI Pharma Services, Commercial Services
11.2013 - 08.2014
Quality Specialist
PCI Pharma Services, Commercial Services
01.2013 - 11.2013
Quality Engineering Technician
PCI Pharma Services, Commercial Services
05.2012 - 01.2013
Quality Control Batch Release Coordinator
PCI Pharma Services, Commercial Services
05.2011 - 05.2012
MBA - Management & Operations
Rockford University
Bachelor of Science - Business Administration And Management
Rockford University