Job Description
Global Head of Quality
Location: Hybrid (Dublin, Ireland)
Contract Type: Permanent
* Lead the global Quality function for a fast-growing pharmaceutical company, providing strategic direction across headquarters and all affiliate sites to drive effective Pharmaceutical Quality Systems and support major international expansion
* Ensure full GxP compliance and inspection readiness across UK, EU/EEA, Australia and New Zealand markets while acting as Responsible Person / Deputy Responsible Person for Wholesale Distribution sites
* Champion continuous improvement through Quality Management Reviews, ICH Q9 Risk Management, e-QMS implementation and hands-on execution of quality and business projects
* Oversee business development due diligence, product acquisitions and partner relationships to maintain the highest standards of manufacturing and distribution
* Competitive salary package with excellent opportunities for professional development, team leadership and real strategic impact in a high-growth environment
* Dynamic hybrid working model with up to 25% international travel in an ambitious, entrepreneurial pharmaceutical business
CHR Life Sciences are exclusively recruiting for our client, a fast-growing and ambitious global pharmaceutical company with significant operations in the UK, Australia and an expanding European footprint, seeking a Global Head of Quality to define and implement their global Quality operating model and support continued geo-expansion.
Position Overview:
As the Global Head of Quality, you will report directly to the Chief Technical Officer and provide senior leadership to the Quality function at Global Headquarters and all affiliate sites. This is a hands-on leadership role operating cross-functionally to ensure the Pharmaceutical Quality System remains effective, controlled and continually improved as the business grows. You will oversee the introduction of acquisition products into the portfolio and play a key part in regulatory strategy and business development activities. The role is hybrid (Dublin-based) with up to 25% travel, including regular visits to the UK headquarters and global partners.
Responsibilities:
- Management and strategic direction of the Quality function at the Global Headquarters and all affiliate sites, working across business functions to ensure the Pharmaceutical Quality System is effective and the company’s ambitious geo-expansion initiatives are achieved
- Ensuring the company’s Pharmaceutical Quality System is in control, effective and continually improved as the business expands its operations
- Ensuring the company’s GxP Global Marketing Authorisation Holder responsibilities are maintained in control and continually improved
- Maintaining the company’s regulatory GxP compliance with UK, EU/EEA, Australia and New Zealand pharmaceutical legislation and guidance; ensuring inspection readiness at all times and hosting regulatory inspections as required
- Acting as a Responsible Person and/or Deputy Responsible Person for the Wholesale Distribution sites in Ireland and the UK
- Working with the Chief Technical Officer to perform business development and product acquisition due diligence activities
- Hands-on approach assisting with the execution of Pharmaceutical Quality System and business activities, ensuring projects are executed on time and in budget
- Development, coaching and mentoring of the Quality function personnel
- Working closely and maintaining excellent relationships with the company’s partners to ensure appropriate standards of manufacturing and distribution are maintained in relation to GMDP matters
- Managing and delivering the Quality Management Review and Quality Metrics, presenting data and identifying continuous improvement actions with the Senior Leadership Team
- Implementation and ownership of ICH Q9 Risk Management system to proactively identify, mitigate and control risks
- Provision of GxP and technical support for the selection, implementation and validation of GxP computerised systems including a planned e-QMS implementation
Requirements:
- Proven senior Quality leadership and management experience
- A strong background in pharmaceutical quality assurance, Good Distribution Practice and Good Manufacturing Practice
- In-depth knowledge of UK and EU/EEA Pharmaceutical legislation and guidance (experience in Australia and New Zealand markets is desirable)
- Experience of Marketing Authorisation Holders and CDMO oversight and management
- Must be eligible to be nominated as a Responsible Person in Ireland and/or the UK (eligibility as a Qualified Person is preferred)
- Lead auditor trained
- Proven experience of developing and coaching personnel
- Comfortable working hands-on at an operational level and thriving in a fast-paced, challenging, entrepreneurial and team-oriented environment while managing multiple activities simultaneously
- Strategic approach with strong organisational skills
- Experience in Technology Transfer and New Product Introduction
- Experience in a wide range of dosage forms including tablets and sterile small molecule products
- Highly motivated, hardworking and driven individual who can work independently as well as part of a cross-functional team
- Excellent communication skills and empathy to build positive, productive and proactive relationships with internal and external stakeholders
- Self-driven, takes ownership and demonstrates high levels of personal accountability, with a proven ability to oversee and collaborate with complex teams