Sr. Director, Quality Assurance Operations
1 month ago
Title: Sr. Director, Quality Assurance Operations
Location: Bridgewater, NJ
Hybrid role: onsite 2-3 days per week, must live near the site or willing to relocate.
Status: Full-time direct hire
Compensation: $250,000 to $280,000
Ideal candidates will have experience in small molecules, biologics, and combination/ medical devices.
Reporting to the Executive Director Quality GMP Compliance, the Sr. Director, Quality Operations will play a key role in managing Quality oversight activities. Responsible for Quality related activities for commercial products including transition from development (Phase III) into commercial.
Responsibilities:
- Responsible for final product Quality release/rejection and related processes.
- Partner with other Regional Quality Directors to ensure transparent communication and assess any product related issues. Impact assessment includes proper evaluation for Health Authority reporting (FAR, Quality Defect, Recalls, etc) and escalation within QA.
- Responsible for supplier day to day relationships of critical suppliers. Using influence, active engagement, and an understanding of compliance requirements, work with critical suppliers to ensure quality, consistent supply.
- Review and approve deviations, CAPAs, SOPs and Change Control related to manufacturing operations
- Partners within QA team to execute supplier risk mitigation strategies, supplier assessments, and Quality Agreements. This may include active participation on Joint Steering Committees, frequent communication with QA Leadership, and direct support of Person In Plant (PIP).
- Responsible for QA representation in Design Control Process for medical device products and combination products.
- Lead the quality assessment for product lifecycle changes, efficiency projects, and continuous improvement projects.
- Manage the performance and development of 3-6 direct reports.
- Support supplier and internal audits as necessary.
Desired Qualifications:
- BS degree in Chemistry, Engineering, Life Science or related discipline and a minimum of 15 years of relevant Quality Assurance experience; advanced degree and a minimum of 10 years relevant experience required
- Minimum 7 years’ experience working in 21CFR211 regulated environment required
- Extensive knowledge of cGMPs and pharmaceutical and medical device manufacturing quality assurance.
- Commercial drug manufacturing site QA head experience preferred
- Ability to drive functional, technical, and operational excellence. Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness.
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