Site Director, Development Quality

The Site Director, Development Quality is a senior leadership role with a significant opportunity to influence how Quality enables the delivery of our exciting development portfolio. At its heart, the role is about protecting patients, ensuring GMP standards are met at the site while creating an environment in which quality enables development teams to move with pace, confidence and appropriate risk management. The Site Director provides Quality leadership at the site and contributes to the strategic direction of Development Quality globally.

As a Quality leader, the role partners with leaders across Development and Supply Chain globally, helping teams build quality in from the outset and achieve business outcomes in compliance with internal standards and external regulatory requirements.

The Site Director also plays an important role in shaping our Quality culture. They set high standards for Quality Leadership, building a Development Quality organization that is recognized as an influential, proactive and valued business partner. Operating with a high degree of independence, the Site Director makes complex quality and compliance decisions that can have significant implications for development projects. This requires sound judgement and the ability to navigate evolving regulatory expectations and the different requirements associated with each stage of pharmaceutical development.

Accountabilities:

Development Quality leadership

Contribute as a member of the Development Quality Leadership Team, sharing responsibility with the Head of Development Quality and fellow leaders for setting and delivering the strategic direction of the function.

• Partner with Quality leaders across the organisation to support an integrated and consistent approach to quality and compliance.
• Act as a Quality Business Partner to senior Development leadership, delivering patient-focused quality perspective to business decisions.
• Lead the response to significant compliance issues, including issue management teams associated with complaints, recalls and other quality events, ensuring patient safety remains paramount while issues are effectively resolved.
• Sponsor and lead functional and cross-functional quality improvement initiatives and ensure appropriate Quality Assurance input to major business improvement programmes.
• Act as a recognised senior expert in Quality Systems, Quality Assurance and the application of GMP within Pharmaceutical Development.
• Ensure high-quality and timely Quality input to development project and supply teams, enabling delivery of 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 and science and risk-based application of Quality Policy, GMP standards and quality practices across project and supply chain teams.
• Ensure the site's pharmaceutical licence to operate is maintained, providing Quality leadership for any regulatory authority interactions.

People and organisational leadership

• Build and lead the local site Quality team, driving performance and ensuring it has the capabilities to meet the future.
• Coach, develop and inspire talent, both within the leadership team and across Development Quality, creating an environment in which people can grow and perform at their best.
• Establish effective ways of working and champion simplification and continuous improvement.
• Deliver against agreed financial and headcount commitments while ensuring resources are focused on the areas of greatest business and patient impact.

Essential Skills/Experience:

We're looking for an experienced Quality leader who combines deep technical credibility with the ability to lead people, influence senior stakeholders and make sound science and risk-based decisions in complex situations. You will bring:

• A relevant bachelor's degree or equivalent scientific/technical qualification, together with at least 10 years of experience in a pharmaceutical GMP environment. Experience within Oral Solid Dosage and inhalation products would be particularly valuable.
• Experience of leading and developing teams
• Strong Quality Assurance leadership experience and a broad understanding of Pharmaceutical Quality Systems and GMP.
• Strong understanding of the pharmaceutical development lifecycle and the different quality and regulatory considerations that apply as products progress through development.
• Experience applying independent judgement and quality risk management to complex situations.
• The confidence and communication skills to influence senior leaders and make and communicate difficult decisions clearly.

Desirable Skills/Experience:

Ideally, you will also demonstrate:

• Strong collaboration, networking and relationship-building skills across organisational and functional boundaries.
• The ability to create effective teams and develop capability in others.

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