Site Director, Development Quality
About The Position
The Site Director, Development Quality is a senior leadership role responsible for providing Quality leadership at the site and contributing to the global strategic direction of Development Quality. The role protects patients, ensures site GMP standards are met, and enables development teams to work with pace, confidence, and appropriate risk management. It partners with leaders across Development and Supply Chain globally to build quality into work from the outset and deliver business outcomes in compliance with internal standards and external regulatory requirements. Operating with a high degree of independence, the Site Director makes complex quality and compliance decisions with significant implications for development projects. The role shapes the Quality culture, sets high standards for Quality Leadership, and builds a Development Quality organization recognized as a proactive and valued business partner. It requires sound judgement and the ability to navigate changing regulatory expectations and the requirements of different pharmaceutical development stages. The role also leads the local site Quality team, develops talent, improves ways of working, and delivers agreed financial and headcount commitments while directing resources toward the greatest business and patient impact.
Requirements
- Relevant bachelor’s degree or equivalent scientific or technical qualification.
- At least 10 years of experience in a pharmaceutical GMP environment.
- Experience leading and developing teams.
- Strong Quality Assurance leadership experience and broad understanding of Pharmaceutical Quality Systems and GMP.
- Strong understanding of the pharmaceutical development lifecycle and the quality and regulatory considerations at different product development stages.
- Experience applying independent judgement and quality risk management in complex situations.
- Confidence and communication skills to influence senior leaders and clearly make and communicate difficult decisions.
Nice To Haves
- Experience with Oral Solid Dosage and inhalation products.
- Strong collaboration, networking, and relationship-building skills across organizational and functional boundaries.
- Ability to create effective teams and develop capability in others.
- Strong facilitation skills and ability to build alignment around complex issues.
- Ability to communicate with clarity, credibility, and conviction at all organizational levels.
- Experience leading change and continuous improvement.
- Track record of setting high standards while enabling people to perform at their best.
- Energy, curiosity, and ambition to continue developing the role and the wider Development Quality organization.
Responsibilities
- Contribute to the Development Quality Leadership Team and share responsibility for setting and delivering the function’s strategic direction.
- Partner with Quality leaders across the organization to support an integrated and consistent approach to quality and compliance.
- Act as a Quality Business Partner to senior Development leadership, providing a patient-focused quality perspective for business decisions.
- Lead responses to significant compliance issues, including issue management teams for complaints, recalls, and other quality events, keeping patient safety paramount.
- Sponsor and lead functional and cross-functional quality improvement initiatives, and ensure appropriate Quality Assurance input to major business improvement programs.
- Serve as a recognized senior expert in Quality Systems, Quality Assurance, and GMP application within Pharmaceutical Development.
- Ensure high-quality, timely Quality input to development project and supply teams to support project milestones and reliable supply of investigational products and comparators to clinical trials.
- Ensure appropriate Quality support for regulatory submissions and pre-approval inspections.
- Drive consistent, science- and risk-based application of Quality Policy, GMP standards, and quality practices across project and supply chain teams.
- Maintain the site's pharmaceutical licence to operate and provide Quality leadership during regulatory authority interactions.
- Build and lead the local site Quality team, driving performance and developing the capabilities needed for the future.
- Coach, develop, and inspire talent within the leadership team and across Development Quality.
- Establish effective ways of working and champion simplification and continuous improvement.
- Deliver agreed financial and headcount commitments while focusing resources on the areas of greatest business and patient impact.
Benefits
- Qualified retirement programs
- Paid time off, including vacation, holidays, and leaves
- Health coverage
- Dental coverage
- Vision coverage
- Eligibility for short-term incentive bonuses
- Equity-based awards for salaried roles
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What This Job Offers
Job Type
Full-time
Career Level
Senior
