Senior Manager
Location: Dublin | Hybrid
About the Opportunity
My client, a leading biopharmaceutical innovator, is seeking a Clinical Product Senior Manager to champion product quality across a cutting-edge clinical portfolio. This is a senior individual contributor role-designed for seasoned Quality Assurance professionals or QPs who want to lead strategically, without managing direct reports.
As the Quality lead for investigational products spanning small molecules, biologics, peptides, and advanced therapies, you'll be at the forefront of clinical development-from early-phase studies to late-stage readiness and beyond.
What You'll Do
Serve as the Quality Lead for multiple clinical programs and modalities (vials, autoinjectors, tablets, etc.)
Partner cross-functionally with CMC, Regulatory, and Technical teams
Develop and drive quality strategies for early- and late-phase clinical manufacturing
Act as Quality SME for submissions (IMPD, IND) and responses
Chair Quality Subteams to align GMP, QP oversight, and compliance
Own product quality risk identification and mitigation
Guide CMO selection, onboarding, and Quality Agreements
Contribute to due diligence and integration of new assets
Support audit readiness and maintain critical documentation
What You Bring
5+ years' experience in GMP QA, ideally across Phases I-III
In-depth knowledge of global regulatory and GMP standards (Annex 16, ICH)
Proven expertise in managing outsourced GMP activities
Strong cross-functional collaboration, influence, and risk-based thinking
A degree in pharmaceutical or life sciences (BSc or higher)
Why This Role?
Lead without line management
Shape strategy across diverse therapies and modalities
Join a collaborative, science-driven environment
Make a tangible impact on early clinical development
Contribute to both internal pipeline and external partnerships
Interested?
If you're ready to bring QP-level expertise to a mission that matters-from first dose to first approval-we want to hear from you.
Join my client's quality leadership team and help ensure patients receive safe, effective, high-quality investigational therapies.
