GSK, a global biopharma leader, is embarking on an ambitious journey to profoundly impact global health. With a strategic vision focused on early intervention, their "Ahead Together" strategy aims to prevent and alter the course of diseases, thereby protecting individuals and supporting healthcare systems worldwide. By 2031, GSK targets £40 billion in annual sales, fueled by a robust portfolio of vaccines, specialty medicines, and general medicines. This role offers a unique opportunity to be at the forefront of innovation and scientific excellence, developing groundbreaking treatments for critical health challenges.
The Opportunity: Global C&Q Director
GSK is seeking a highly experienced and strategic Global C&Q Director to lead and standardize commissioning and qualification (C&Q) activities across its global capital projects. This pivotal role ensures that all project equipment, systems, and processes meet stringent regulatory and company standards, safeguarding product quality and patient safety. You will be instrumental in establishing best-in-class C&Q practices, leveraging digital advancements and AI to drive superior performance and efficiency.
Key Advantages for Candidates:
- Strategic Leadership: Shape and implement global C&Q strategies, policies, and procedures, influencing the direction of critical projects and ensuring alignment with business objectives and regulatory mandates.
- Global Impact: Oversee C&Q for major capital projects across diverse geographies, contributing directly to GSK's mission of impacting billions of lives.
- Innovation and Technology: Drive the adoption of digital and AI solutions within C&Q, positioning you at the cutting edge of industry advancements and enhancing operational efficiency.
- Cross-Functional Collaboration: Work closely with engineering, quality assurance, manufacturing, and regulatory affairs teams, fostering a collaborative environment and building strong internal and external partnerships.
- Professional Growth: Opportunities for team development, mentoring, and acting as a global ambassador for diversity and GSK's Safety Life Saving Rules, contributing to your professional development and leadership acumen.
- Hybrid Work Model: This role offers a flexible hybrid working model, combining the benefits of on-site engagement with the flexibility of remote work, with preferred locations in major European or US-based GSK manufacturing hubs.
Key Considerations for Your Career Path:
- Extensive Validation Expertise: A strong foundation in project validation, with proven experience leading validation teams in the pharmaceutical or biotech industry is essential.
- Global Project Management: Demonstrated success in leading and managing complex, end-to-end global C&Q projects across multiple geographies is crucial.
- Regulatory Acumen: Deep knowledge of regulatory requirements (FDA, EMA, MHRA, GMP, GAMP, ICH) and experience defending validation plans and results during regulatory audits are critical.
- Technical Depth: Experience with biopharmaceutical-specific unit operations (drug substance/primary, DP/sterile filling, and packaging) and a comprehensive understanding of the capital project lifecycle are highly valued.
- Stakeholder Influence: The ability to build and maintain strong relationships with diverse stakeholders and exert influence across all organizational levels is key to success.
- Adaptability and Problem-Solving: Thrive in ambiguous environments and possess strategic thinking skills to effectively solve complex problems.
- Preferred Qualifications: Advanced degrees (Masters in Engineering, MBA), professional certifications (CSP, PMP), and a solid understanding of GSK's project processes and Quality Management Systems will enhance your application.
This role is an exceptional opportunity for a seasoned C&Q professional looking to make a significant impact within a purpose-driven organization. By joining GSK, you will contribute to a culture of innovation, collaboration, and a commitment to improving global health, all while advancing your career in a dynamic and supportive environment.