Site Director, Development Quality
About The Position
The Site Director, Development Quality is a senior leadership role responsible for providing Quality leadership at a site and contributing to the global strategic direction of Development Quality. The role protects patients, ensures site compliance with GMP standards, and helps development teams deliver 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 achieve 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 requires sound judgment and the ability to navigate changing regulatory expectations and requirements across pharmaceutical development stages. The Site Director helps shape Quality culture, sets high standards for Quality Leadership, and builds a proactive, influential Development Quality organization recognized as a valued business partner. The role contributes to the Development Quality Leadership Team's strategic direction, partners with Quality leaders to support consistent quality and compliance, and advises senior Development leadership as a Quality Business Partner. It leads responses to significant compliance issues and sponsors quality improvement initiatives. The Site Director provides expertise in Quality Systems, Quality Assurance, and GMP in Pharmaceutical Development; ensures timely Quality input to development projects and supply teams, regulatory submissions, and pre-approval inspections; and supports maintenance of the site's pharmaceutical licence to operate. The Site Director also builds and leads the local site Quality team, develops talent across Development Quality, establishes effective ways of working, champions simplification and continuous improvement, and delivers agreed financial and headcount commitments while prioritizing resources according to 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 that apply as products progress through development.
- Experience applying independent judgment and quality risk management to complex situations.
- Confidence and communication skills to influence senior leaders and clearly communicate difficult decisions.
Nice To Haves
- Experience within 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 levels of the organization.
- Experience leading change and continuous improvement.
- Track record of setting high standards while creating an environment in which people can deliver 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, bringing a patient-focused quality perspective to business decisions.
- Lead responses to significant compliance issues, including issue management teams for complaints, recalls, and other quality events.
- Sponsor and lead functional and cross-functional quality improvement initiatives and provide appropriate Quality Assurance input to major business improvement programs.
- Serve as a senior expert in Quality Systems, Quality Assurance, and applying GMP within Pharmaceutical Development.
- Ensure high-quality, timely Quality input to development projects and supply teams to support project milestones and reliable supply of investigational products and comparators for 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 for regulatory authority interactions.
- Build and lead the local site Quality team, driving performance and ensuring it has capabilities to meet future needs.
- 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 areas of greatest business and patient impact.
Benefits
- Eligibility for short-term incentive bonuses.
- Equity-based awards for salaried roles.
- Qualified retirement programs.
- Paid time off, including vacation, holidays, and leaves.
- Health coverage.
- Dental coverage.
- Vision coverage.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
