Director, Quality Assurance – Value Chain Management
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Job Description
Quality leadership role overseeing end-to-end quality program for antibody drug conjugates. Collaborating with teams for high-quality product supply throughout the commercial lifecycle.
Responsibilities:
- Oversee the end‑to‑end quality program for an assigned product value chain in antibody drug conjugates.
- Be a core member of the Value Chain Management Team, partnering across functions to ensure a reliable supply of high‑quality products throughout their commercial lifecycle.
- Lead end‑to‑end quality oversight for the product program, ensuring compliance with procedures and regulations.
- Develop and maintain the Product Quality Strategy and Product Analytical Strategy in line with supply strategy.
- Partner with Quality, Regulatory, Technical, Supply Chain, and site Quality teams to align priorities and resolve issues.
- Strengthen and harmonize Quality Management Systems and ways of working, sharing best practices across sites.
- Stay current with regulatory requirements, support or lead inspections, and drive ongoing inspection readiness.
- Provide quality leadership to product focus teams, the Value Chain Management Team, and related working groups.
- Lead quality communications across the network, including meetings, updates, and escalation of issues and risks.
- Support analytical siting strategies and broader value‑chain projects, ensuring quality input and follow‑through.
- Track and interpret change control, complaints, and quality performance data to identify trends.
- Review Annual Product Reviews, evaluations, and post‑marketing product reviews to assess and communicate risks.
- Monitor, report and mitigate quality and supply chain risks across the franchise.
Requirements:
- At least 10 years of experience in the pharmaceutical industry, including experience in a leadership role.
- Quality and/or technology experience in vaccines or large molecule products is an advantage.
- Experience in continuous improvement or analytical science is desirable.
- Strong project management skills and the ability to drive complex initiatives to completion.
- Clear, confident communication skills, both written and verbal.
- Experience leading multi-functional teams to deliver strategic outcomes.
- A degree or postgraduate qualification in a relevant Science, Pharmacy, or Engineering field.
- Proven ability to drive change and improvement initiatives.
- Strong leadership and stakeholder management skills, with the ability to influence at multiple levels.
- Commitment to continuous professional development and continuous improvement.
- A track record of success in team environments (for example, project teams, Six Sigma teams, or continuous improvement teams).
Benefits:
- Flexible working hours
- Professional development opportunities
- Willingness to travel 10-15% for assignments
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