Product Quality Lead
About The Position
The Product Quality Lead provides cross-functional quality leadership and supports program deliverables for assigned products and associated on-going life-cycle management activities including product transition from clinical to commercial, new product introductions and technology transfers across the network. The PQL is acting as main point of contact for providing assessment, guidance, and/or requirements relating to product quality aspects to cross-functional teams supporting the product lifecycle. The PQL is the quality representative of the development strategy of the product, ensuring global supply of IMPs and commercial products.
Requirements
- High-level education in pharmaceutical, biotech, or life sciences
- At least 10 years of experience in pharmaceutical and biotech products under GMP
- Proven experience in Pharmaceutical Development Organization being able to transition development projects into future commercial set-up.
- Strong leadership skills with a proven track record with Health Authorities
- Deep understanding of GMP & GDP requirements and strategic planning
- Fluent in English with excellent communication and interpersonal skills
Responsibilities
- Ensure end-to-end compliance for product manufacturing and life cycle management, from clinical phase the termination of the commercialization of the product (as applicable)
- Provide Quality inputs in submission dossiers
- Implement and maintain Quality Risk Assessment and KPIs
- Lead complex changes
- Coordinate product QA activities across markets (e.g. launch)
- Provide guidance on product quality aspects and support site transfers
- Participate in audits and inspections
- Design SOPs and contribute to operational development
- Contribute to input in Quality aspect of Due Diligence processes
- Advice / leads Complex quality issues and influence global solutions to ensure continuous drug supply to patients.
- Collaborates closely with the rest of the Quality functions to ensure product quality requirements, issues, or solutions are promptly communicated at all appropriate levels
- Support recall
- Responsible for coordination / issuing and approval of the APQR
- Contribute to developing and streamlining own operations
- Lead & coordinate Quality aspect for integration of new acquisitions
- Cooperate with team members and contribute to a positive work environment
Benefits
- Competitive compensation for your work
- Generous time off policy
- Opportunity to broaden your horizons by attending popular conferences
- Emphasis on work/life balance
- Collaborative and team-oriented environment
- Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
