Associate Director - Quality
- Experience Level
- Assures adequate release of product that meets requirements per product specifications to applicable geographies.
- Collaborate with Production and Manufacturing Sciences management in the areas of cGMP compliance and quality systems.
- Provides direction in the event of manufacturing incidents that may potentially affect quality or compliance.
- Responsible for management of investigations, CAPAs, batch record review, product release, change control, requalification and product annual review.
- Responsible for review and approval of changes to process, equipment, procedures, and systems.
- Support the facility during external and regulatory inspections.
- Implement lean concepts to continuously improve cycle times within the area or responsibility
- Participate to core team meetings and support division-led improvement projects
- Act as QP delegate and lead the weekly QP meetings
- Must have 8-10 years’ experience
- 5 years experience in leadership, supervisory or management experience in the pharmaceutical or biotechnology within Quality
- University degree or equivalent in Engineering, Chemistry, Life Science or other job related discipline.
- Certification desired in ASQ, Green Belt, Lean or equivalent
- Strong knowledge of cGMP (US, Swiss, EU, Canadian, Japan) required
- Demonstrates proficiency in multiple quality systems including exception management, change control, document control, product release, supplier quality, etc. with strong decision-making skills utilizing risk management.
- Lead multiple tasks/projects within timeline: strong verbal, written, oral communication skills. Able to present business indicators to senior management.
- Fluent in English and in French.
- Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
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