Director Quality Operations
EyePoint
9 days ago
Remote friendly (Northbridge, MA)
United States
Operations
Primary responsibilities include:
- Manage internal and external quality operations supporting GMP manufacturing (clinical and commercial).
- Plan, organize, and direct QA Operations for incoming material release, batch record review, QC testing, lot disposition, Quality Event Management, Annual Product Report reconciliation, and quality oversight of manufacturing facilities.
- Serve as Quality Lead on program teams (product development and manufacturing operations).
- Lead Quality Event Management CAPAs and the change control process.
- Lead cross-functional risk analysis for CAPA, change controls, complaint investigation, failure investigation (FMEA), and hazard assessments (HACCP).
- Lead root cause analysis determination.
- Lead, mentor, and develop the Quality Operations team.
- Collaborate cross-functionally to define and complete pre-approval inspection and commercial readiness activities.
- Arbitrate compliance discussions and negotiate required corrective actions.
- Identify, recommend, and implement enhancements to Quality Operations processes and procedures.
- Manage and provide QA support for Process Validation activities.
- Hire/retain staff and provide performance feedback; set goals aligned to department plans; coach and mentor; maintain a safe/professional work environment.
Required skills & knowledge:
- Leadership of cross-functional teams; influence without direct authority.
- Thorough knowledge of Quality Systems, cGMPs, and US regulations for small molecule drug substances/drug products.
- Ability to review/approve/critique protocols and reports for equipment, pharmaceutical processes, and medical devices.
- Inspection readiness/P AI inspection involvement.
- Scale-up experience for commercialization.
- Strong GMP experience across development to commercialization, including validation.
- Proven track record advancing programs (Phase I through commercialization) as a Quality lead.
- Ability to manage multiple priorities in a fast-paced environment.
Other requirements:
- Experience auditing; oversee CMO operations.
- Domestic travel; combination device experience.
Required education & experience:
- Bachelor’s degree (scientific/technical); master’s preferred.
- Minimum 15 years in pharma/biotech, preferably development and Quality Assurance Operations.
- Manage internal and external quality operations supporting GMP manufacturing (clinical and commercial).
- Plan, organize, and direct QA Operations for incoming material release, batch record review, QC testing, lot disposition, Quality Event Management, Annual Product Report reconciliation, and quality oversight of manufacturing facilities.
- Serve as Quality Lead on program teams (product development and manufacturing operations).
- Lead Quality Event Management CAPAs and the change control process.
- Lead cross-functional risk analysis for CAPA, change controls, complaint investigation, failure investigation (FMEA), and hazard assessments (HACCP).
- Lead root cause analysis determination.
- Lead, mentor, and develop the Quality Operations team.
- Collaborate cross-functionally to define and complete pre-approval inspection and commercial readiness activities.
- Arbitrate compliance discussions and negotiate required corrective actions.
- Identify, recommend, and implement enhancements to Quality Operations processes and procedures.
- Manage and provide QA support for Process Validation activities.
- Hire/retain staff and provide performance feedback; set goals aligned to department plans; coach and mentor; maintain a safe/professional work environment.
Required skills & knowledge:
- Leadership of cross-functional teams; influence without direct authority.
- Thorough knowledge of Quality Systems, cGMPs, and US regulations for small molecule drug substances/drug products.
- Ability to review/approve/critique protocols and reports for equipment, pharmaceutical processes, and medical devices.
- Inspection readiness/P AI inspection involvement.
- Scale-up experience for commercialization.
- Strong GMP experience across development to commercialization, including validation.
- Proven track record advancing programs (Phase I through commercialization) as a Quality lead.
- Ability to manage multiple priorities in a fast-paced environment.
Other requirements:
- Experience auditing; oversee CMO operations.
- Domestic travel; combination device experience.
Required education & experience:
- Bachelor’s degree (scientific/technical); master’s preferred.
- Minimum 15 years in pharma/biotech, preferably development and Quality Assurance Operations.