Sr. Director, Quality Systems & Compliance
Bristol Myers Squibb
5 days ago
On-site
Bothell, WA
Operations
Position Summary:
Sr Director, Quality Systems & Compliance (full-time) at BMS Bothell Manufacturing Plant (JuMP) in Bothell, WA. Lead Quality Systems and Compliance teams to ensure site Quality Systems (Deviation, CAPA, Change Control, Complaints, Data Integrity, Quality Risk Management, Document Control) are designed, implemented, measured for cGMP compliance/effectiveness; ensure health authority compliance and inspection readiness; lead self-inspection and data integrity programs; oversee quality governance, management escalations, and health authority notifications; partner cross-functionally with Cell Therapy sites and global counterparts.
Duties/Responsibilities:
- Identify/implement Quality Systems and risk management; author policies/SOPs; guide staff.
- Oversee QMS areas (Deviation/CAPA/Change Control/Complaints/Data Integrity/QRM/Document Control).
- Enable corporate QMS/Risk/Data Integrity policies and IT tools for effectiveness/efficiency.
- Maintain reporting/documentation; ensure cGMP training requirements.
- Run self-inspection, data integrity, document/records management, Quality Council metrics.
- Drive continuous improvement, inspection readiness, root cause analysis and improvement.
- Manage health authority inspections/third-party audits; manage responses and corrective actions.
- Lead APQR compilation/review; support licenses/dossiers; health authority reporting/correspondence.
Qualifications/Skills:
- Bachelor’s (science or related).
- 12+ years in Cell Therapy/biotech/pharma; Quality Management System leadership.
- Extensive knowledge of FDA/EMA/PMDA and ROW GMP/ATMP; ICH Q10, ICH Q9, 21 CFR Part 11.
- Experience with health authority/third-party audits; deviation/CAPA/change control/QRM; document & records/electronic systems.
- cGMP training (LMS), leadership, strong communication, project planning, MS Office; Quality systems/statistical electronic tools.
Compensation/Benefits (if applicable): $235,080–$284,867; additional incentive cash/stock possible. Benefits include medical/dental/vision, wellbeing support, 401(k), disability/life insurance and related protections; paid time off per role/location eligibility.
Application instructions: Apply; if role doesn’t match perfectly, apply anyway.
Sr Director, Quality Systems & Compliance (full-time) at BMS Bothell Manufacturing Plant (JuMP) in Bothell, WA. Lead Quality Systems and Compliance teams to ensure site Quality Systems (Deviation, CAPA, Change Control, Complaints, Data Integrity, Quality Risk Management, Document Control) are designed, implemented, measured for cGMP compliance/effectiveness; ensure health authority compliance and inspection readiness; lead self-inspection and data integrity programs; oversee quality governance, management escalations, and health authority notifications; partner cross-functionally with Cell Therapy sites and global counterparts.
Duties/Responsibilities:
- Identify/implement Quality Systems and risk management; author policies/SOPs; guide staff.
- Oversee QMS areas (Deviation/CAPA/Change Control/Complaints/Data Integrity/QRM/Document Control).
- Enable corporate QMS/Risk/Data Integrity policies and IT tools for effectiveness/efficiency.
- Maintain reporting/documentation; ensure cGMP training requirements.
- Run self-inspection, data integrity, document/records management, Quality Council metrics.
- Drive continuous improvement, inspection readiness, root cause analysis and improvement.
- Manage health authority inspections/third-party audits; manage responses and corrective actions.
- Lead APQR compilation/review; support licenses/dossiers; health authority reporting/correspondence.
Qualifications/Skills:
- Bachelor’s (science or related).
- 12+ years in Cell Therapy/biotech/pharma; Quality Management System leadership.
- Extensive knowledge of FDA/EMA/PMDA and ROW GMP/ATMP; ICH Q10, ICH Q9, 21 CFR Part 11.
- Experience with health authority/third-party audits; deviation/CAPA/change control/QRM; document & records/electronic systems.
- cGMP training (LMS), leadership, strong communication, project planning, MS Office; Quality systems/statistical electronic tools.
Compensation/Benefits (if applicable): $235,080–$284,867; additional incentive cash/stock possible. Benefits include medical/dental/vision, wellbeing support, 401(k), disability/life insurance and related protections; paid time off per role/location eligibility.
Application instructions: Apply; if role doesn’t match perfectly, apply anyway.