Catherine Watkins
Newburyport,MA
Summary
Abstract. Strong industry experience in all phases of product lifecycle, and experience leading complex projects in multi-disciplinary, global companies. Ability to work in a highly dynamic, fast-paced, multi-cultural environment. Seeking to create clarity in complex situations while distilling communication of intricate projects, problems, and technical solutions for common understanding and forward movement.
Overview
19
19
years of professional experience
Work History
Sr. Director, Global Product Quality
BioNTech
05.2023 - Current
- Accountable for creating structured approaches to communication and governance to support the product quality network
- Led cross-functional teams to define and effectively implement product lifecycle processes and standards
- Set and maintained quality strategy across BioNTech portfolios to support commercialization efforts
- Set up governance for complex impacting changes (e.g. global changes, multi-product or multi-site) and for proactively identifying quality risks and improvement opportunities across the cell therapy network
- Provided a network for product intelligence and ensuring product information is available and approved
- Developed, with the help of cross-functional teams, a quality strategy to be maintained for consistency and standardization
- Ensured systems were in place for quality support for preparation of CMC clinical and commerical regulatory submissions and associated Health authority questions
Site Head of Quality
Cell & Gene Therapies BU, Lonza
04.2022 - 03.2023
- Developed, implemented and monitored of Quality programs, policies and procedures to ensure compliance with GMP standards, corporate policies
- FDA, EMA and other regulatory body regulations and guidelines
- Proven experience in senior leadership position
- Aseptic processing expertise and implementation of EU GMP Annex 1
- Proven experience implementing initiatives to drive Quality programs and ensure maximum productivity
- Ensured systems met the needs of all internal and external constituencies with an emphasis on process, quality, productivity, budget control, and profitability
- Served as the point person with industry partners regarding product quality matters, customer satisfaction levels and regulatory authority interaction
- Evaluated all current Quality systems and processes and recommended and implemented appropriate enhancements to ensure the achievement of long-term objectives
- Created active training and development plans for Quality staff with the objective of driving the overall competence and professionalism of the Quality functions
- Served as the company Quality expert, providing solid, well-informed, actionable Quality support to Operations and other functions as requested
Head of Validation
Lonza
01.2019 - 03.2021
- Led all aspects of Validation for one of the largest manufacturing facilities in North America, (~69,677 sq.m)
- Ensured that manufacturing related GMP systems and controls meet Global Quality standards and applicable regulatory requirements regarding qualification and validation
- Accountable for validation strategies, programs, continuous improvement, and team leadership for equipment and utilities qualification/validation, process equipment cleaning validation, and computer systems validation
- Interfaced between capital project teams and site validation teams to ensure commissioning / qualification plans and activities are developed and executed appropriately for project needs and site validation requirements
- Ensured validation component of capital projects was completed on schedule and within budget
- Built and maintained expertise in validation within validation teams, ensuring development of validation managers and staff
- Maintained cross-site and industry connections to ensure Lonza's validation programs remained at the forefront of the Lonza network and biopharma industry
- Site Data Integrity Lead – managed performance of DI program, strategic direction, and risk framework
- Partnered with stakeholders to advance data standardization, process simplification, data quality enhancement and automation where needed
- Engineering Business Partner - Provided QA oversight and collaboration with the Engineering Department
Manager, Computerized Systems Validation
Lonza
01.2019 - 04.2023
- Oversaw validation and launch of computerized systems including: Process Control Systems (PCS), Distributed Control Systems (DCS), Building Automation System (BAS), QC Lab and Manufacturing Equipment software and standalone software applications via ISPE GAMP, EU Annex 11, and 21 CFR Part 11
- Applied lessons learned and remained informed of industry regulatory changes as it applies to computer systems validation
- Maintained periodic review program for computer systems validation group
- Ensured proper structuring of the CSV group as well as budgeting and resource planning
Manager, Quality Systems
Vericel Corporation, Formerly Genzyme Sanofi
10.2017 - 01.2019
- Managed Change Control, Periodic Product Quality Reviews, Design Control, Quality Management Reviews and Risk Management
- Facilitated and led external regulatory inspections
- Coached and mentored team within QS department
- Managed projects including Design History Files (DHFs) and Device Master Records (DMRs)
- Established and managed Site Risk Profile
- Fostered environment of teamwork and open communication
- Established and track Key Performance Indicators (KPIs) annually for Quality- related metrics
Supervisor, Validation Engineer
Vericel Corporation, Formerly Genzyme Sanofi
03.2015 - 10.2017
- Managed all QMS quality records for the validation department (from initiation, plan development, through to closure)
- Managed, coached and mentored team within the Validation department
- Project management of changes to GMP systems (facilities, utilities, equipment), as well as revalidation following equipment failures
- Proficient in TrackWise Quality Management System (IQ/OQ/PQ of v8.7) and all system workflows
- Validation Assessments (SME) and project manager for change control
Validation Engineer
Vericel Corporation, Formerly Genzyme Sanofi
07.2012 - 03.2015
- Performed IQ/OQ/PQ (initial and requalification) studies on equipment, computerized systems, ISO 5 and ISO 7 cleanrooms, and utilities, CFR 21 Part 11 and EU Annex 11
- Performed requalification quality reviews and statistical analysis to support site requalification program
- Participated in internal and external audit inspections
- Created department SOPs for equipment validation under ISO/FDA regulations and regulatory requirements
- Validated databases and computer systems for reporting quality and reliability data
- Liaison to metrology department, generated validation and calibration metrics
- Improved validation processes by developing and implementing risk-based strategies for equipment, systems, and facilities.
Validation Engineer
Bristol Myers Squibb
05.2011 - 06.2012
- Established and maintained validation infrastructure to ensure compliance with current regulatory expectations such as programs for periodic revalidation, cleaning validation, equipment validation, sterilization validation and process validation
- Performed IQ/OQ/PQ (initial and requalification) studies on equipment including but not limited to: SIP/CIP and process vessels, autoclaves, freezers, refrigerators, vacuum ovens, and review of chromatography column validation studies
- Project management: creating, entering and managing project timelines
- Worked with external vendors for contracted validation activities to ensure compliance with corporate and regulatory standards
- Trained staff in cGMP, validation practices and regulatory compliance
Senior Research Support Specialist
The Research Foundation, SUNY
09.2004 - 06.2008
- Research for the Department of Paper and Bioprocess Engineering
- Operated small-scale bioreactors for wood product engineering research
- CIP of small-scale bioreactors Research pertaining to paper production
- Digestion of wood in digesters and post-batch processing as well as laboratory analysis
- Laboratory analysis: Kappa, Viscosity tests, Kraft and Hot-water extraction and NMR extract analysis Exploration of wood products for potential renewable energy source
Education
Master of Science - Bioprocess Engineering
SUNY ESF
12.2011
Bachelor of Science - Environmental Science
University of New Hampshire
Skills
- Problem-solving Abilities
- Manage Talent and People Development
- Operational Manufacturing and Budget Forecasting
- Proven ability in leading global and local site teams in the management and completion of multiple, complex projects
- Ability to think strategically and proactively identify issues to address with a collaborative, solutions-oriented approach
- Strong ability to distill complex problems into simple solutions
Timeline
Sr. Director, Global Product Quality
BioNTech
05.2023 - Current
Site Head of Quality
Cell & Gene Therapies BU, Lonza
04.2022 - 03.2023
Manager, Computerized Systems Validation
Lonza
01.2019 - 04.2023
Head of Validation
Lonza
01.2019 - 03.2021
Manager, Quality Systems
Vericel Corporation, Formerly Genzyme Sanofi
10.2017 - 01.2019
Supervisor, Validation Engineer
Vericel Corporation, Formerly Genzyme Sanofi
03.2015 - 10.2017
Validation Engineer
Vericel Corporation, Formerly Genzyme Sanofi
07.2012 - 03.2015
Validation Engineer
Bristol Myers Squibb
05.2011 - 06.2012
Senior Research Support Specialist
The Research Foundation, SUNY
09.2004 - 06.2008
Master of Science - Bioprocess Engineering
SUNY ESF
Bachelor of Science - Environmental Science
University of New Hampshire
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