Quality Control Associate Director
Vertex Pharmaceuticals
4 hours ago
Remote friendly (Boston, MA)
United States
Operations
Key Responsibilities
- Develop and execute Lifecycle Management (LCM) strategies to ensure continuous improvement, scalability, and compliance across QC processes, with a focus on ongoing supply continuity for all markets.
- Act as a Digital Champion by driving digital maturity initiatives, including digital integration of external data into the Vertex data platform and advanced data analytics.
- Lead Quality System improvements, including Out-of-Specification (OOS) management strategies, alignment, and execution.
- Collaborate with and provide oversight of Contract Manufacturing Organizations (CMOs) and Contract Testing Laboratories (CTLs) to ensure quality standards are met and maintained.
- Represent QC in Change Control Governance and Endorsement Forums and Deviation Governance Teams.
- Lead Operational Excellence (OpEx) initiatives across CMO sites and CTLs, engaging Vertex OpEx leads for efficiencies and best practices.
- Prepare content and present CMO/CTL performance metrics and improvement initiatives for Quality Leadership Team (QLT) and Quality Management Review (QMR) meetings.
Qualifications
- Bachelor’s Degree in LifeScience or a related discipline (required).
- Proven experience in Quality Control within the pharmaceutical or biotechnology industry.
- Typically requires 10 years of experience in pharmaceutical/biopharmaceutical industry.
- Strong expertise in LCM strategy development and execution.
- Demonstrated ability to lead quality system improvements.
- Strong technical acumen to troubleshoot testing issues, lead investigations, and manage OOS processes effectively.
- Experience working with CMOs/CTLs and representing QC in governance forums.
- Proficiency in digital tools and systems; track record as a Digital Champion.
- Excellent leadership, communication, and collaboration skills.
Preferred Qualifications
- Advanced degree in a related field (plus).
- Experience leading cross-functional Operational Excellence (OpEx) initiatives.
- Familiarity with data integration and digital transformation in laboratory environments.
Flex Designation / Work Location
- Hybrid-Eligible or On-Site Eligible: choose Hybrid (remote up to two days/week) or On-Site (five days/week on-site with ad hoc flexibility).
- Develop and execute Lifecycle Management (LCM) strategies to ensure continuous improvement, scalability, and compliance across QC processes, with a focus on ongoing supply continuity for all markets.
- Act as a Digital Champion by driving digital maturity initiatives, including digital integration of external data into the Vertex data platform and advanced data analytics.
- Lead Quality System improvements, including Out-of-Specification (OOS) management strategies, alignment, and execution.
- Collaborate with and provide oversight of Contract Manufacturing Organizations (CMOs) and Contract Testing Laboratories (CTLs) to ensure quality standards are met and maintained.
- Represent QC in Change Control Governance and Endorsement Forums and Deviation Governance Teams.
- Lead Operational Excellence (OpEx) initiatives across CMO sites and CTLs, engaging Vertex OpEx leads for efficiencies and best practices.
- Prepare content and present CMO/CTL performance metrics and improvement initiatives for Quality Leadership Team (QLT) and Quality Management Review (QMR) meetings.
Qualifications
- Bachelor’s Degree in LifeScience or a related discipline (required).
- Proven experience in Quality Control within the pharmaceutical or biotechnology industry.
- Typically requires 10 years of experience in pharmaceutical/biopharmaceutical industry.
- Strong expertise in LCM strategy development and execution.
- Demonstrated ability to lead quality system improvements.
- Strong technical acumen to troubleshoot testing issues, lead investigations, and manage OOS processes effectively.
- Experience working with CMOs/CTLs and representing QC in governance forums.
- Proficiency in digital tools and systems; track record as a Digital Champion.
- Excellent leadership, communication, and collaboration skills.
Preferred Qualifications
- Advanced degree in a related field (plus).
- Experience leading cross-functional Operational Excellence (OpEx) initiatives.
- Familiarity with data integration and digital transformation in laboratory environments.
Flex Designation / Work Location
- Hybrid-Eligible or On-Site Eligible: choose Hybrid (remote up to two days/week) or On-Site (five days/week on-site with ad hoc flexibility).