Associate Director, Quality Assurance - MSD Ireland
Location: Ballydine, County Tipperary, Ireland
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Quality Assurance / Industries: Pharmaceutical Manufacturing
Requisition ID: R376246
Job Posting End Date: 01/5/2026
Job Overview
An amazing opportunity to lead quality assurance at our Ballydine site. You will report to the Quality Director and partner with the Quality Leadership Team to ensure our Drug Substance, Spray Dried Intermediate, and Drug Product are compliant and ready for downstream customers. This hands‑on, people‑centered role requires strong leadership, judgment, and a commitment to continuous improvement.
Responsibilities
Provide quality support to the Integrated Process Teams to ensure the facility meets all Good Manufacturing Practice (GMP) requirements for development, clinical, and commercial supply.
Participate as a team member in documentation review and approval, deviation management, quality risk management, change control, and new product introduction.
Lead and support GMP audits and regulatory inspections (internal, customer, regulatory). Serve as lead auditor for walkdowns and systems audits to maintain compliance and inspection readiness.
Accountable for the development and performance of the team, providing coaching on professional development and ensuring responsibilities are delivered following inclusion principles and behaviours.
Lead and support continuous improvement of quality and site processes.
Qualifications
Degree or postgraduate qualification in Science, Pharmaceutical or Engineering.
Minimum of 5 years experience in the pharma regulated industry with leadership experience; clinical and commercial GMP experience preferred.
Excellent knowledge of regulations and sources of regulatory information.
Experience with regulatory inspections.
Qualified Person qualification is an advantage.
Experience in high potency manufacturing, continuous manufacturing, spray drying, laboratory GMP and project management is desirable.
Demonstrated continuous improvement mindset and capabilities.
Dynamic individual with excellent organisational skills, capable of collaborating with cross‑functional teams.
About Us
We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
Apply
Invent solutions to meet unmet healthcare needs, please apply today.
We encourage you to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
#J-18808-Ljbffr