Process Documentation / Compliance / Project Management
Telford,PA
Summary
Professional with extensive experience in project management and leading global cross-functional teams to document processes, eliminate process gaps, analyze metrics, and institute meaningful controls to ensure the highest level of compliance.
Overview
22
22
years of professional experience
Work History
Martial Arts Instructor
Action Karate
04.2023 - Current
Instruct group and private self-defense classes for children and adults
Assist students in development of life skills to improve focus, determination, confidence, and self-assurance to pursue goals
Certified as Program/Enrollment Director, Ambassador, and Instructor for all age groups; lead community and on-site events
Foster a positive learning environment by promoting respect, self-discipline, and teamwork among students
Implement effective classroom management techniques to maintain order during intense training sessions while prioritizing safety
Provide constructive feedback to students through one-on-one sessions, highlighting areas of improvement while celebrating their achievements
Built strong relationships with parents through regular communication regarding student progress, expectations, and additional support as needed
Process and Procedural Document Specialist, Associate Director – SOP and Training, Operations Center of Excellence, Global Product Development
Pfizer
01.2011 - 04.2023
Led team of subject matter experts in development, revision, process mapping, implementation, and maintenance of process standards and procedural documentation related to clinical, medical, safety, and regulatory processes
Provided strategic recommendations regarding process design, documentation development, change management, and supporting systems
Planned and managed projects to address full life cycle: requirements and policy setting; process design, documentation, training development, and delivery; change management planning and deployment; and transition to oversight system incorporating performance monitoring and continuous improvement
Produced processes and related documentation that met regulatory requirements, supported corporate compliance, were inspection ready, and were designed with operational effectiveness in mind and contained measurable controls
Collaborated with training developers on training strategies and plans
Contributed to compliance and audit/inspection readiness strategies and plans
Evaluated procedural documentation against evolving industry/regulatory requirements and expectations, audit/inspection findings, business needs, changes in industry standards and client feedback and trends, making recommendations for change when necessary
Managed queries and deviations from organization related to policies/SOPs
Served as departmental representative on project teams
Process and Procedure Development Lead – Development Operations, Operational Performance Strategies
Pfizer
03.2010 - 12.2010
Led development, revision, process mapping, implementation, and maintenance of SOPs and associated procedural documents
Supported corporate compliance and inspection readiness objectives
Provided unified and consistent approach to process and procedure development and management using appropriate tools and systems to map processes
Led and applied project management to global SOP teams and development and implementation of targeted SOP projects to meet divisional and global needs
Provided critical analysis to subject matter experts for evaluation, design, development, and implementation of SOP projects
Provided technical writing support for global SOP teams; maintained SOP metrics
Worked proactively with research and business units, platform functional lines, and training to ensure effective communication and roll-out of new technologies and business processes supporting SOPs
Provided leadership and recommendations regarding SOP development and supporting systems at divisional and global levels
Procedural Compliance Associate II - Global Compliance and Training (GCaT), Procedural Compliance
Pfizer
01.2010 - 03.2010
Reviewed Global Clinical Team (GCT) processes ensuring that each process was linked and in alignment with process map from beginning to end and was documented in SOPs
Developed GCT policies, SOPs, standard practice instructions (SPIs), and guidance documents
Performed quality review of GCT and GCaT process documents
Provided project management support for tasks associated with moderate to complex clinical processes
Developed and managed project plans, established timelines, and identified issues
Supported GCaT process owners, senior management for process management, policies, SOPs, training, and global support with GCT communications and projects
Managed tasks associated with GCT policy and SOP process and associated documents for compliance with regulations, laws, company policy, and GCT best practice
Procedural Compliance Associate I - Global Compliance and Training, Procedural Compliance
Wyeth/Pfizer
01.2008 - 12.2009
Developed GCT policies, SOPs, SPIs, and guidance documents
Performed quality review of GCT and GCaT process documents
Facilitated/participated in key process/project teams and SOP team meetings
Assisted with project management tasks to support clinical processes
Supported GCaT process owners and senior management
Procedural Compliance Analyst - Global Compliance and Training, Procedural Compliance
Wyeth
11.2005 - 12.2007
Supported GCT SOP document management process
Managed GCT SOPs and SOP associated documents
Supported and managed SOP information tracking; managed departmental web pages
Supported tasks requiring access to SOPs and associated documents (eg, audits and inspections)
Education
Bachelor of Arts - Organization Dynamics / Human Performance Mgmt.
Immaculata University
Malvern, PA
Skills
Matrix management
Process and procedural documentation (eg, policies, standard operating procedures [SOPs], supporting documents)
Process modeling
Corrective and preventive action
Team building
Quality management systems, documentation systems
Goal setting and achievement
Continuous learning mindset
Highly organized with attention to detail
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Work Preference
Work Type
Full TimeContract Work
Work Location
On-SiteRemoteHybrid
Timeline
Martial Arts Instructor
Action Karate
04.2023 - Current
Process and Procedural Document Specialist, Associate Director – SOP and Training, Operations Center of Excellence, Global Product Development
Pfizer
01.2011 - 04.2023
Process and Procedure Development Lead – Development Operations, Operational Performance Strategies
Pfizer
03.2010 - 12.2010
Procedural Compliance Associate II - Global Compliance and Training (GCaT), Procedural Compliance
Pfizer
01.2010 - 03.2010
Procedural Compliance Associate I - Global Compliance and Training, Procedural Compliance
Wyeth/Pfizer
01.2008 - 12.2009
Procedural Compliance Analyst - Global Compliance and Training, Procedural Compliance
Wyeth
11.2005 - 12.2007
Bachelor of Arts - Organization Dynamics / Human Performance Mgmt.
Immaculata University
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