Responsibilities
- Serve as team lead to internal QA team members
- Lead QA oversight of CDMO and internal QA activities, ensuring compliance with regulatory/GMP expectations and established Quality Agreements
- Support and maintain vendor assessment activities
- Provide quality management of vendors using risk-based decision-making during manufacturing and testing activities
- Support quality performance and continuous improvement activities
- Oversee quality of third-party supplier services, including manufacturing, filling, packaging, and shipping as appropriate
- Maintain regular oversight through periodic monitoring, auditing, and Quality Agreement reviews
- Manage Data Verification activities to ensure data integrity and compliance with GDP
- Identify opportunities to improve quality systems and clinical-to-commercial operational processes and drive implementation to completion
- Develop, monitor, and report quality metrics and KPIs to support Quality Management Review
- Support quality systems, including internal and external deviations and change controls
- Assess product, compliance, and operational risks and partner with cross-functional teams to develop and implement risk management strategies
- Review and approve controlled documents
- Perform other duties as assigned
Requirements
- Bachelor’s degree in Biology, Chemistry or other relevant scientific discipline preferred
- 8-10 years of cGMP Quality Assurance experience with cell therapy, biologics, and/or small molecule programs
- 5+ years of experience directly managing a team of direct reports within QA
- Commercial QA experience a plus
- Travel required up to 35%
- Experience with eQMS (e.g., ACE, TrackWise)
- Working knowledge of current industry practices and standards in an FDA-regulated biotechnology company
- Excellent record keeping and documentation skills
- Strong verbal and written communication skills, with the ability to concisely present information in cross-functional settings
- Experience working with CDMOs preferred
- Proficient use of MS Office products
- Ability to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance, and a great sense of urgency while ensuring that all cGMP and regulatory requirements are met
- Ability to work effectively both independently and with other team members
Core Competencies
Demonstrates expertise in Quality Assurance with a focus on cGMP compliance, risk management, and vendor quality oversight. xayajpt Proven ability to lead teams, manage quality metrics, and implement continuous improvement initiatives in a regulated biotechnology environment.
Highest-signal resume keywords
- CGMP Quality Assurance Experience
- Team Management
- Risk Management Strategies
- EQMS Proficiency
- Quality Metrics Development
Hard Skills
- Quality Management
- Data Verification
- Regulatory Compliance
- Quality Systems Support
- Quality Agreement Reviews
- Documentation Skills
- Quality Performance Improvement
- Auditing
- Risk-Based Decision-Making
- Clinical-to-Commercial Operational Processes
Soft Skills
- Strong Communication Skills
- Adaptability
- Team Collaboration
- Flexibility
- Sense of Urgency
Industry Keywords
- Biotechnology
- CDMO
- FDA Regulations
- Biologics
- Cell Therapy
- Small Molecule Programs
- GMP Expectations
- Quality Agreements
Tools & Technologies
- EQMS (ACE, TrackWise)
- MS Office
Associate Director, Quality Assurance Arbeitgeber: Jobtailor
Als Front Office Supervisor in unserem dynamischen Team bieten wir Ihnen die Möglichkeit, in einem unterstützenden und freundlichen Arbeitsumfeld zu wachsen. Wir legen großen Wert auf die berufliche Entwicklung unserer Mitarbeiter und bieten regelmäßige Schulungen sowie die Chance, Verantwortung zu übernehmen. Unsere Lage ermöglicht es Ihnen, Teil einer lebendigen Gemeinschaft zu sein, während Sie gleichzeitig die Standards unseres Franchise-Partners einhalten und unseren Gästen einen unvergesslichen Aufenthalt bieten.
