Gwendolyne Nieves Alcocer
Bothell,WA
Summary
Accomplished professional with 25 years of experience in the Pharma/Biotech Manufacturing Industry. Demonstrates a proven record of excellence. Skilled in managing and driving compliance initiatives such as deviations, CAPAs, change controls, and Quality Management Systems (QMS) metrics to ensure inspection readiness. Extensive expertise in leading and developing training programs, conducting needs assessments, task analysis, and creating comprehensive training materials. Proficient in training delivery and utilizing LMS technology. Possesses a strong background in documentation and policy compliance, including authoring responses to health authority inquiries and supporting site business continuity plans and risk assessments. Proven ability to collaborate cross-functionally, manage teams, and drive continuous improvement initiatives within the Supply Chain and Quality Assurance functions. Exceptional communication and computer skills with a focus on customer service and delivering results. Demonstrated expertise in Quality Systems, including Change Management, Deviation, and CAPA Programs, while providing technical writing support. Customer-focused professional with successful 25-year career in Pharma/Bio industry.
Overview
12
12
years of professional experience
Work History
Manager - Compliance, Supply Chain Operations
Bristol Myers Squibb
07.2022 - Current
- Led and managed department compliance initiatives, including Deviations, CAPAs, and Change Controls
- Supervised a team responsible for compliance and operational initiatives within the Supply Chain
- Supported site business continuity plans and risk assessments as a Supply Chain representative
- Reported on and escalated relevant QMS metrics, resolving problematic or overdue records
- Managed creation, implementation, and compliance for documentation, procedures, and policies
- Ensured inspection readiness for the Site Supply Chain department, including SOP reviews and preparation activities for scheduled inspections
- Authored responses to health authority inquiries and information requests
- Reviewed change controls and collaborated with Site Supply Chain functions to ensure appropriate actions are created and completed
- Drove departmental training compliance and maintained relevant curriculums
- Participated in audits and Health Authorities Inspections, documented observations, and led CAPA closures
- Maintained and updated departmental procedures, work practices, and protocols
- Led cross-functional initiatives to evaluate, update, and implement site business continuity plans
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or deficiencies.
- Maintained professional, organized, and safe environment for employees and patrons.
Quality Assurance Specialist
Seagen Inc.
05.2020 - 07.2022
- Managed change control quality program, including training staff on eQMS (Veeva) and leading continuous improvement activities
- Developed and maintained relationships with cross-functional teams and third parties for change control activities
- Represented Quality Programs on cross-functional teams, supporting various operational programs and audits
- Authored and revised quality procedures and other department operating procedures
- Provided subject matter expertise for audits and inspections
- Guided successful project completions, often in project leadership role
- Made independent decisions within change management program's defined procedures and practices
- Supported related quality programs, such as Deviation and CAPA management, on ad-hoc basis
- Led and performed validation activities for Change Control Program
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
Training Supervisor (GMP)
AGC Biologics
04.2019 - 05.2020
- Developed and executed GMP Training program and schedule, ensuring compliance with program requirements
- Prepared training reports to measure compliance and supported client and regulatory audits
- Trained and supported newly hired GMP staff cross-functional and inter-site training improvement projects
- Provided support for dealing with human error non-conformances
- Delivered training programs, including Annual GMP refresher courses for 650 staff members
QA Associate III
Seagen Inc.
05.2014 - 03.2019
- Served as principal System Administrator and System Owner of Electronic Learning Management System (UL Compliance Wire), ensuring system validation, updates, and compliance
- Maintained role-based training curricula and coordinated annual GMP refresher training
- Designed and developed eLearning training using Adobe Captivate software
- Managed training assignments for new/revised procedures and supported system users
- Authored and revised quality procedures, collaborated with cross-functional teams, and prepared training metrics for management
- Hosted internal audits and provided support for GMP Training Program
- Provided cross-functional support for related quality programs, such as Change Management and Deviation/CAPA Programs
- Collaborated with cross-functional teams to ensure seamless integration of new features and functionalities
- Improved product quality by conducting thorough testing
Training Specialist
Kelly Services at Amgen Manufacturing Limited
07.2012 - 05.2014
- Developed and delivered Serialization Overview training and On-the-Job Training Qualifications for Serialization Project staff
- Designed and conducted cultural awareness conferences in preparation for international audits
- Delivered effective training to client groups, new hires, and existing staff through classroom, one-on-one, and on-the-job sessions
- Assessed and approved training assignments for staff, ensuring compliance and readiness for audits
- Collaborated with clients to implement training plans and supported client audits related to staff training compliance
- Assessed additional needs based on training progress and collaborated with management to meet requirements.
Education
MBA - Human Resources Management
Universidad Del Turabo
Caguas, PR05.2001
BA - Management
Universidad De Puerto Rico
Cayey, PR05.1995
Skills
- Customer service
- Team leadership
- Time management
- Decision-making
- Staff training and development
- Goal setting
- Documentation and reporting
- Cross-functional teamwork
- Project planning
- Change management
- Regulatory compliance
- Computer skills
- Effective communication
- Adaptability and flexibility
- Positive attitude
- Attention to detail
Accomplishments
Improved significantly the Compliance status of the Supply Chain Department by frequently measuring Key Compliance Indicators, ensuring these are addressed promptly and/or maintained as required.
Training
- Change Control, Deviations and CAPAs
- Risk Management
- Train the Trainer
- Good Manufacturing Practices
- Good Documentation Practices
- Human Performance Fundamentals
- Resilience and Change Management Skills Certified - CCMC, Inc.
- Criterion-Referenced Instruction – The Center for Effective Performance, Inc.
- Emotional Intelligence
Languages
English
Native or Bilingual
Spanish
Native or Bilingual
Timeline
Manager - Compliance, Supply Chain Operations
Bristol Myers Squibb
07.2022 - Current
Quality Assurance Specialist
Seagen Inc.
05.2020 - 07.2022
Training Supervisor (GMP)
AGC Biologics
04.2019 - 05.2020
QA Associate III
Seagen Inc.
05.2014 - 03.2019
Training Specialist
Kelly Services at Amgen Manufacturing Limited
07.2012 - 05.2014
MBA - Human Resources Management
Universidad Del Turabo
BA - Management
Universidad De Puerto Rico
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