Associate Director Quality – Pharm Operations & Centre of Excellence
MSD Ballydine develops and supplies the active ingredients and final formulated product for a range of innovative medicines at its manufacturing and R&D facilities. The plant, which has been operating in Tipperary for over 40 years, exports to over 25 countries around the world with primary markets being Europe, USA and Japan.
Our highly-skilled local workforce of 500 employees is now leading the way in the development of new medicines, including MSD’s treatment for hepatitis C, which is being manufactured in Tipperary for patients around the world.
MSD Ballydine’s existing portfolio and future pipeline offers team members the opportunity to operate at the cutting-edge of science and technology, and develop new treatments that positively impact patients across the globe.
Our Manufacturing Division, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
& SPECIFIC OBJECTIVES
- Reporting to the Director of Quality, the Quality Leader Oral Solid Dose IPT and Quality Systems CoE is a member of the site quality leadership team.
- The Quality Leader is a self directed, decision maker who is responsible for the management and oversight of the Quality Management Systems in the Drug Substance and Drug Product facilities and for the achieving the Quality deliverables in the Drug Product Integrated Process Teams (IPTs).
- The Quality Leader leads the QP team to ensure all Oral Solid Dose intermediate and finished product are released in compliance with GMP.
- The Quality Leader leads and develops the Quality Systems and Quality Drug Product teams, ensuring that the site meets all Manufacturer’s Licence requirements for clinical and commercial production and is audit ready for both customers and agency inspections.
- The role includes participation (as representative of MSD) in national quality organisations, staying abreast of regulatory developments, communication of such trends and developments to the Ballydine site and recommending appropriate action plans.
- The Quality Leader may delegate for the Site Quality Director.
- Responsible for providing leadership and guidance on site-wide quality assurance and regulatory compliance.
- Team Leadership: The Quality Leader is accountable for the development and performance of the Qualified Person team, Senior Quality Assurance Specialists and Quality Assurance Specialists in the COE and IPT teams.
- Responsible for the continuous improvement of the site quality management systems.
Quality Systems CoE Principal Accountabilities:
Lead the Quality Systems COE team to ensure timely and effective completion of the Quality Systems core functions, including;
- Quality Council System and Site Compliance Plan Management
- Creation, review and approval of Site Quality documentation including; Site Master File, Validation Master Plan, policies and procedures.
- MAH Licence maintenance and support for product filings
- Quality Agreement System Management
- Annual Review System Management
- Supplier and Customer complaints System Management
- Quality SME for Process, Cleaning, Water and Equipment Validation
- Quality SME for Change Control (Process / Analytical / Supplier)
IPT Drug Product Principal Accountabilities:
Lead the Drug Product QP and Quality Specialist team to ensure timely and effective completion of the Quality IPT core functions, including;
- Production support and quality compliance insight and guidance to ensure the facility meets and operates to all GMP requirements for development, clinical and commercial supply.
- Assist the IPT leadership team to deliver business results for the IPT in line with overall site goals.
The position reports to the the Quality Director
- A minimum of 5 year experience in the Pharma regulated industry with Quality leadership experience
- Demonstrated Continuous Improvement mindset and capabilities
- Experienced in aligning individuals and teams to business objectives
- Detailed knowledge of Pharmaceutical GMP and Regulatory expectations
- Oral Solid Dose manufacturing processes
- Demonstrated success in managing a team in a pharmaceutical production environment
- Highly developed people leadership and development skills
- Degree or post graduate qualification in Science, Pharma or Engineering field
- Qualified Person qualified (advantageous)
So, if you are ready to:
INVENT solutions to meet unmet healthcare needs
IMPACT the future by joining MSD, one of the world’s leading healthcare companies
INSPIRE your team to reach their full potential and push the boundaries of science and technology
Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.