Kelly Wall
Summary
A seasoned pharmaceutical professional with a comprehensive background in Quality Assurance, Manufacturing solid dose, injectables, and Regulatory Compliance, currently spearheading Investigations in a Pharma aseptic environment. Proven expertise in mentoring and leading a team of professionals, orchestrating thorough interviews, root cause analyses, and assessments within the Quality Management System (QMS). Demonstrated success in adhering to approved Deviation Management Procedures, Sterile Manufacturing Process Improvement, collaborating with Customers, Quality Assurance, Manufacturing and Project Managers, and consistently meeting all stringent FDA and validation requirements. In-depth experience encompasses the initiation and evaluation of deviations, issuance of CAPAs, meticulous tracking through systems like Trackwise, and reporting on weekly and monthly progress. Exceptional proficiency in driving continuous improvement, reducing quality events, and implementing fully electronic QMS systems. Notably, adept at managing Global Quality initiatives, conducting successful FDA/DEA audits, and overseeing serialization and UDI implementation for Pharma and medical devices. A certified Lean Six Sigma Black Belt, SQF Practitioner, Auditor, HACCP certified, and a Certified Quality Auditor. Comprehensive knowledge of Global Manufacturing Strategies and building strong supplier relationships. Successfully implemented nationwide Quality initiatives and achieved SQF ratings above 98% during audits at CP Flexible Packaging. Excelled as a Quality Manager at GlaxoSmithKline, overseeing worldwide third-party contractors and establishing effective Ways of Working while working with R&D to bring new opportunities to the market.
Overview
30
30
years of professional experience
1
1
Certification
Work History
Head Investigator
Catalent Biotech
07.2023 - Current
- Lead, onboard and Mentor a group of 15 Investigators
- Conduct thorough interviews with personnel, analyze root causes, assess impacts, and identify corrective/preventive actions, ensuring strict adherence to approved Catalent Deviation Management Procedures
- Initiate and evaluate deviations within the Quality Management System (QMS) at Catalent
- Issue monthly reports highlighting opportunities for improvement in all areas of the organization, accompanied by relevant recommendations
- Adhere meticulously to the Catalent Investigations Procedure, promptly notifying/escalating any potential risks to distributed products or processes identified during investigations
- Apply approved Catalent Deviation Management Procedures to assess, categorize, and conduct root cause analysis upon the assignment of investigations
- Ensure the expedited handling of deviations to promptly close backlogs
- Immediate classification (Minor, Major, Critical) upon assignment facilitates the swift closure of minor investigations, while major and critical cases undergo thorough evaluation to address identified risks through management
- Follow approved Catalent Deviation Management Procedures to promptly notify management of any potential product impacts identified during investigations
- Manage the investigation lifecycle process using Trackwise, consistently applying Deviation Management Procedure requirements
- Evaluate and issue CAPAs, diligently tracking them through the applicable system with corresponding responsible owners
- Collaborate directly with customers to resolve any concerns related to investigations to expedite the close out of the investigation.
Head of Operation- York Plants
RHI Magnesita
12.2022 - 07.2023
- Over 400 employees
- Led CAPEX and leakage closure of 19 million dollars in 7 months, resulting in a 30% increase in productivity and an increase of employee retention of 20% overall to prior year
- Led the plant to be most profitable plant with the best quality in North America and across other regions such as Europe, Mexico, China, India
- Improved Morale by engaging employees, performing salary market analysis to source talent, safety meetings and engagement, reducing safety incidents by 25%
- Responsible for multi- million-dollar budget for the plants
- Plan, organize, direct, and run optimum day-to-day operations to exceed our customer's expectations
- Responsible for the success of Engineering, Project Management, Manufacturing, Quality Assurance, Continuous Improvement, Maintenance, Warehouse etc
- Identified, mentored, trained, and groomed Successor for Plant Manager position.
- Skilled at working independently and collaboratively in a team environment.
- Self-motivated, with a strong sense of personal responsibility.
- Proven ability to learn quickly and adapt to new situations.
- Worked well in a team setting, providing support and guidance.
- Worked effectively in fast-paced environments.
- Managed time efficiently in order to complete all tasks within deadlines.
- Demonstrated respect, friendliness and willingness to help wherever needed.
- Excellent communication skills, both verbal and written.
- Passionate about learning and committed to continual improvement.
- Proved successful working within tight deadlines and a fast-paced environment.
- Strengthened communication skills through regular interactions with others.
- Adaptable and proficient in learning new concepts quickly and efficiently.
- Organized and detail-oriented with a strong work ethic.
- Used critical thinking to break down problems, evaluate solutions and make decisions.
- Worked flexible hours across night, weekend and holiday shifts.
Consultant- Quality and Regulatory Compliance
QPSI
04.2022 - 12.2022
- File NDC's and regulatory license updates
- Audit, identify areas to be addressed, lead the team in fixing manufacturing processes
- Design and build ISO 6 clean room for primary filling
- Prepare all SOP's, WIs, and forms for ISO 6 cleanroom
- Implement an electronic training program (Mango).
Vice President Quality
CP Flexible Packaging
04.2019 - 04.2022
- Identified and established KPIs to improve team efficiency and sales strategies
- Identified problems and implemented solutions to better streamline operations by reducing waste by 9.4% in one year
- Implement and support nationwide Quality initiatives to achieve customer and operational quality objectives
- Identify and drive areas for continuous improvements to reduce Quality events and unnecessary spend by reducing customer complaints by 3.9% in 1 year saving over 2.2 million dollars in returns
- Led the Food Safety team to achieve best in the industry SQF ratings across 5 sites of >98% during audits and maintain the food safety program year-round to be compliant with GFSI
- Oversight for 11 plants across the US and Canada including a medical device clean room facility in California
- Achieved ISO 13485 and 9001 certifications
- Eliminated fully manual Quality system by implementing a fully electronic Quality Management System that is Part 11 compliant to 21 CFR Parts 210/211/820.
- Enhanced company profitability by implementing strategic business plans and optimizing operational processes.
- Led cross-functional teams for the successful completion of major projects, resulting in increased efficiency and client satisfaction.
- Spearheaded organizational restructuring initiatives, streamlining operations and reducing overhead costs.
- Established a culture of continuous improvement, fostering innovation and driving sustainable growth across the organization.
- Managed financial planning and budgeting processes, ensuring fiscal responsibility and maximizing return on investments.
- Cultivated strong relationships with key stakeholders, including customers, vendors, regulators, and community leaders to promote collaboration and long-term success.
General Manager- Pharma
QPSI
12.2017 - 04.2019
- Responsible for the plant production, quality, profitability, and full management
- Providing Quotes RFP/RFQ based on labor/hours and machine efficiencies
- Develops strategic plan by studying efficiencies and financial opportunities
- Accomplished subsidiary objectives by establishing plans, budgets, and results measurements; allocating resources; reviewing progress; making decisions
- Coordinates efforts by establishing procurement, production, marketing, field, and technical services policies, and practices; coordinating actions with corporate staff
- Responsible for profitability, LCM, RPLH, brought consistent profitability to the plant for the first time since start up.
Vice President- Quality/Regulatory Compliance
Quality Packaging Specialists International, QPSI
10.2013 - 12.2017
- Implement and support nationwide Quality initiatives to achieve customer and operational quality objectives
- Ensure that operational metrics (KPI) are accurately and effectively used to track trends in performance, to prevent or quickly address issues as soon as they occur
- Direct point of contact for FDA concerns, recalls, inspections
- Responsible for any FDA responses or notifications
- Identify and drive areas for continuous improvements to reduce Quality events and unnecessary spend by implementing a fully electronic QMS system
- Ensure that all sites employ the full range of process development, risk mitigation and problem-solving tools as required
- Drive Global Quality initiatives throughout the Region
- Responsible for all medical device updates and new medical devices filings with FDA
- Develop and drive departmental budget
- Conducted 20 + FDA/DEA successful audits with no 483's
- Assist manufacturers in filing with the FDA
- Lead and coach the validation and process engineers at each site
- Implemented serialization and UDI for Pharma and medical devices.
Regional Quality Manager, QA Manager
Menasha Rand Group
01.2008 - 10.2013
- QA Manager for Menasha Rand at in-house DC for Johnson & Johnson
- QA Manager for Menasha Rand in Edwardsville, IL
- Oversight of 2 plants
- Responsible for all customer complaint reports, responding, investigating, follow –ups and close outs
- Responsible for creating and maintaining all SOP's and controlled forms
- Responsible for performing GMP training and maintaining training records through QCBD system
- Responsible for the Change Control program and issuing and following up and all change controls for the facility
- Responsible for documenting, maintaining, and following up the CAPA program
- Responsible for creating and executing all validation IQ/OQ/PQ
- Responsible for all product release, product hold, risk management HACCP management
- Handle all FDA/DEA and Department of Health licenses and renewals
- Perform internal audits and represent FDA/DEA/DOH audits
- Create NCR's, deviations and performs all investigations
- Responsible for incoming and outgoing shipment inspections.
Product Quality Manager
GlaxoSmithKline
01.2005 - 01.2008
- Responsible for all quality related issues for worldwide third-party contractors
- Managed 11 different contractor plants around the world
- Establish Ways of Working and Quality Management System roll out for all third-party contractors
- Guided all contractors with writing and responding to all customer complaints related to their manufacturing plant
- All complaints had to be reviewed and approved by me before sending to our complaint center
- All field alerts related to my contractors were directly investigated and written by myself along with any recalls that were initiated
- Filed MDR with FDA when the severity of the complaint exceeded a defined threshold
- Performed Health Hazard Evaluation on all complaints, incidents
- Thorough understanding of investigating and creating CAPA's of adverse issues and reporting to the FDA
- Excellent interpersonal skills for building relationships with third party contractors
- Responsible for Global Manufacturing Strategies pertaining to quality on project teams and work closely with R&D and business support for new projects to meet project launch dates with quality products
- Write packaging guidelines, Quality Agreements, SOP's
- Issue FDA notifications
- Review annual stability reports for responsible products
- Review and approve Validation reports (IQ/OQ/PQ/PV) for third party contractors
- Review and approve batch records, Release batches for commercial sale
- Approve all third-party change controls, initiate change controls for internal changes, approve all Third-party deviations, investigations
- Travel domestic and international to visit and audit third party contractors
- Managed stability testing and reviewed and evaluated results.
Laboratory Technician/Manufacturing Supervisor
Sanofi-Aventis
01.1994 - 01.2003
- Worked in sterile Manufacturing Process Improvement (MPI) to produce two (2) conjugate vaccines in early R&D stages and clinical trials which is now on the market
- Worked on assays, HPLC, CIP, X-Cel programs for fermentation of meningitis and sterilization, filtration, formulas, centrifugation, etc
- Collaborated with a team to create batch records, specs, testing requirements, raw materials etc
- For new drug opportunities
- Third shift supervisor to Lead the Meningitis team in the sterile manufacturing fermentation process for injectable vaccines.
Education
Microbiology -
East Stroudsburg University
Northampton Community College
Skills
- Leadership and People Development
- Strategic Planning and Execution
- Process Improvement
- Industry Best Practices
- Regulatory Compliance
- Mergers and Acquisitions
- Complex Problem Solving
- Industry Expertise
- Evidence Analysis
- Risk Assessment
- Leadership Abilities
- Critical Thinking
- Decision Making
Certification
ASQ Lean Black Belt
SQF Practitioner
USDA HACCP Certified
ASQ Certified Quality Auditor
US Veteran
Timeline
Head Investigator
Catalent Biotech
07.2023 - Current
Head of Operation- York Plants
RHI Magnesita
12.2022 - 07.2023
Consultant- Quality and Regulatory Compliance
QPSI
04.2022 - 12.2022
Vice President Quality
CP Flexible Packaging
04.2019 - 04.2022
General Manager- Pharma
QPSI
12.2017 - 04.2019
Vice President- Quality/Regulatory Compliance
Quality Packaging Specialists International, QPSI
10.2013 - 12.2017
Regional Quality Manager, QA Manager
Menasha Rand Group
01.2008 - 10.2013
Product Quality Manager
GlaxoSmithKline
01.2005 - 01.2008
Laboratory Technician/Manufacturing Supervisor
Sanofi-Aventis
01.1994 - 01.2003
Microbiology -
East Stroudsburg University
Northampton Community College
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