Head of Quality Assurance

Company Profile
Ace Pharmaceuticals (Ace) is an independent pharmaceutical company operating in the niche market of medical need products to satisfy the unmet demand of small patient groups. By doing this, the company makes a valuable contribution to society. Via its state-of-the-art facility and C(D)MO’s, Ace carries out the development, production, and distribution of its products. In addition, Ace manufactures and distributes pharmaceutical compounded products for pharmacies. For more information: www.ace-pharm.nl

Position Summary
The Head of Quality Assurance is ultimately accountable for safeguarding product quality while enabling business continuity through balanced, risk based decision making, timely product release, and sustainable regulatory compliance. The Head of Quality Assurance is a senior leader and member of the Management Team, reporting directly to the CEO. The role requires sound judgement, a pragmatic leadership style and the ability to balance regulatory requirements with business objectives with much focus on product quality and patient safety. This role holds end to end accountability for product releases, Quality Management System, GMP compliance, inspection readiness and overall quality performance within a fast paced, private equity backed pharmaceutical environment.

Primary Value Creation

• Ensure timely and compliant product disposition and batch release to safeguard uninterrupted patient supply.
• Make balanced, risk based quality decisions that appropriately consider product quality, patient safety, regulatory compliance, commercial priorities and product availability.
• Exercise sound judgement in determining when quality issues require escalation and ensure timely, transparent communication to the CEO and MT where appropriate.
• Maintain an effective, scalable and inspection ready Quality Management System that supports continued business growth.
• Lead successful Health Authority inspections and customer audits while maintaining full GMP, GDP and GxP compliance.
• Drive continuous improvement of quality systems, quality processes and organizational effectiveness.
• Provide strong leadership and development to the Qualified Persons and the QA Operations, QA Systems and QA Validation teams, creating a high performing quality organization.
• Build a proactive quality culture in which compliance, operational excellence and business performance reinforce each other.

Candidate Profile

Experience

• 15+ years of experience within the pharmaceutical industry.
• At least 10 years of progressive leadership experience within Quality Assurance.
• Experience within a mid-sized pharma company, private equity backed, entrepreneurial and transformational environment is a strong plus.
• Proven leadership of multidisciplinary quality organizations within a GMP regulated manufacturing environment.
• Extensive experience interacting with regulatory authorities and successfully leading GMP inspections.
• Demonstrated experience balancing quality, compliance and operational performance in a commercial manufacturing environment.

Functional Expertise

• Deep expertise in GMP, GDP and applicable GxP regulations.
• Extensive knowledge of Quality Management Systems (QMS).
• Product disposition and batch release processes.
• Quality Risk Management.
• Deviation, CAPA and Change Control.
• Validation and Qualification.
• Supplier Quality Management and oversight of external manufacturing partners.
• Inspection management and Health Authority interactions.
• Thorough understanding of pharmaceutical manufacturing processes and quality oversight across the product lifecycle.

Leadership & Competencies

• Demonstrates excellent judgement and consistently makes balanced, risk based decisions, recognizing both quality requirements and business priorities without compromising patient safety or compliance.
• Pragmatic, solution oriented and able to distinguish between critical issues and operational noise
• Commercially aware while maintaining uncompromising standards for product quality and regulatory compliance
• Provides calm, credible and visible leadership in a regulated environment.
• Knows when to decide independently and when timely escalation is required to ensure appropriate executive involvement.
• Leads through influence, collaboration and accountability rather than hierarchy.
• Strong people leader with a proven track record in coaching, developing and retaining high performing teams.
• Drives a culture of ownership, continuous improvement and operational excellence.
• Resilient and effective under pressure, particularly during inspections, product quality issues and business critical situations.
• Strong communication and stakeholder management skills with the ability to challenge constructively when required.

Education

• Master’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Chemistry, Biotechnology or a related scientific discipline.
• Additional education in Leadership, Quality Management and Operational Excellence

Languages

• English: full professional proficiency (must-have); Dutch: preferred

Compensation & Benefits
Ace Pharmaceuticals offers a competitive compensation package, aligned with the scope, seniority, and strategic impact of the role. The total remuneration will be tailored to the experience, track record, and overall fit of the selected candidate.

Contact
Ace Pharmaceuticals has exclusively appointed Ms. Saskia Richmond, Recruitment Lead at Ace, to manage this search. Potentially interested candidates are invited to reach out in confidence for further information or to express their interest.

Please contact Ms. Saskia Richmond via e-mail at [email protected] or by phone at +31 6 20 58 50 29. All enquiries will be handled with the utmost discretion.