Driven to uphold the highest standards in pharmaceutical compliance? Step into this role where your expertise ensures operational integrity and supports the delivery of safe, effective treatments worldwide.

Hobson Prior is seeking a dynamic and highly experienced Head of Quality & GMP Operations to lead and evolve Quality Management Systems and ensure unwavering compliance within our manufacturing environment. This pivotal role requires a seasoned quality leader who can not only manage complex quality processes but also drive cultural transformation, build high-performing teams, and strategically align quality with business objectives.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

Lead the development, optimization, and remediation of robust Quality Management Systems (QMS) in alignment with global GMP regulations (FDA, EMA, ICH).
Expertly manage core quality processes including deviations, CAPAs, change control, document management, and comprehensive audit readiness
Apply deep understanding of aseptic processing principles, environmental monitoring, cleanroom behaviours, and sophisticated contamination control strategies to ensure product integrity.
Champion and lead significant cultural and operational transformation initiatives within the quality function and across the organization.
Build, reshape, and continuously foster a strong quality culture within a dynamic and fast-paced environment.
Drive accountability for quality and compliance across all cross-functional teams, extending beyond the Quality Assurance department.
Create and champion an environment where compliance goals are seamlessly integrated with and actively support broader business objectives.
Mentor, coach, and develop Quality Assurance professionals, fostering a high performing and engaged team.
Work collaboratively and effectively with manufacturing, technical operations, and supply chain teams, understanding and supporting their operational priorities while consistently upholding stringent quality standards.
Capable of engaging, influencing, and communicating effectively at all organizational levels, from floor staff to executive leadership.
Transparent, persuasive, and adept at leading through influence, skilfully managing resistance, and building crucial buy-in for new systems, tools, and ways of working.
Drive efficiency by simplifying and streamlining QA processes without compromising compliance or effectiveness.
Make informed, data-driven decisions, understand when escalation is necessary, and apply sound risk management principles to QA decision-making and process optimization

Key Skills and Requirements:

Experience in drug product manufacturing, with strong technical expertise. Biologics, steriles, and aseptic manufacturing experience are all relevant.
A proven culture builder who can inspire a team. We are looking for a leader who can create a positive vision and identity for the Quality team-not a "police-type" leader.
Experience with CDMOs is preferred but not required. Candidates without this experience must demonstrate a commercial mindset and the ability to thrive in a fast-paced environment.
Experience leading a whole Quality team, acting as a Site Head.
Experience hosting regulatory inspections (FDA is a must; Swissmedic is a bonus).
Experience with people-focused change management.
Language: Professional English is required. German is a benefit, or at least a willingness to learn

For more information, please contact Jacob Tutt.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.hobsonprior.com/privacy-policy.