Associate Director (M2) External Site Quality Leader (ESQL)- EQA Sterile (EU) Job - Ireland
MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
MSD Manufacturing Division, MMD, 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.
The Associate Director, ESQL, External Quality Assurance will be managing a group of quality professionals responsible for implementing Divisional, and Company policies, procedures and guidelines and for effectively managing the QA/QC responsibilities at External Partners (EPs) manufacturing Merck products.
These activities include the broadest possible involvement in every aspect of manufacturing and testing operations related to the quality and compliance of products produced. The incumbent is responsible for the release of all manufactured products at an EP governing manufacture, testing, packaging, storage, and distribution of sterile pharmaceutical products and to assure they have been produced from approved processes in conformance to all applicable regulatory requirements and Company policies.
1. Adapts functional plans and priorities to address resource and operational challenges.
2. Anticipates and interprets customer and stakeholder needs to identify solutions.
3. Directs the EQA EU cGMP program including maintaining permanent inspection readiness at sterile EPs.
4. Assures that the Quality Operations staff operate within established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, EPA, etc.), both domestic and foreign.
5. Maintains and directs an on-going continuous improvement program to improve efficiency in the department through introduction of new technology, new methods and new procedures to streamline the Quality processes.
6. Ensures talent is managed and developed appropriately to create an engaged and capable workforce
7. Serves as an EQA and MMD subject matter expert in specific Quality systems, technology platforms, regulatory expectations and/or EP management. Utilizes this expertise to drive improved and compliant processes/systems for EQA and MMD.
8. Assures the development and maintenance of a Quality Agreement with the EP. Provides input into the development of contractual agreements with the EP.
9. Executes a program of calibrated Quality oversight based on the product type, capabilities, and quality and compliance performance of the EP.
10. Responsibility for oversight of an EP involving releasing sterile pharmaceutical products, with the assurance that the goods were produced in conformance to all applicable policies and procedures of Merck and compliance with all governing regulations. Before shipment, he/she will assure that products manufactured by the plant have the correct quality and identity, meet all pertinent specifications and special requirements, and have been produced by approved processes and under proper conditions.
11. Has responsibility for Quality Assurance and control functions to include direct support to EPs, coordination and oversight for product testing, as well as other relevant components as determined by applied calibrated Quality oversight. These components may include review of batch documentation and deviation investigations.
12. Has responsibility for maintenance and oversight of ongoing EP management to include regulatory inspection support and monitoring, internal complaint management, internal customer feedback coordination, and review of annual product reviews.
13. Reviews all audit outcomes pertaining to the EP’s and ensures appropriate and timely corrective actions are identified and implemented.
14. Monitors efforts to improve the EP’s quality and reliability through ongoing oversight and formal communication programs and forums.
15. Provides support to the EP’s to facilitate and validate new product introductions.
16. Conducts quality due diligence assessments for pre-approval considerations of new EP’s.
17. Develops presentations for Quality Council meetings. Provides oversight for presentation content and may support issuance of minutes.
18. Coordinates significant investigations including Fact Findings and product recalls as needed.
19. May act as the regulatory compliance liaison on MSD’s behalf to interface with regulatory agencies.
20. Closely collaborates with appropriate business and operations areas to achieve MMD and MSD objectives.
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.
• Degree or 3rd level qualification (Chemistry, Microbiology, Production, Mechanical, Minimum of 10 Years of Experience in the Pharmaceutical industry, including Aseptic Processing and Quality Operations experience.
• People management experience required.
• Extensive experience in Contract Manufacturing Oversight (CMOs, Labs, etc.) required.
• Quality Agreement negotiation and implementation skills are required.
• Strong understanding of Merck Sterile Standards required.
Job: Qual Assurce - 3rd Party Manuf Job Title:Associate Director External Site Quality Leader (ESQL)- EQA Sterile (EU)
Primary Location: EMEA-Ireland-Munster-Brinny
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings: 1
External Job Board Posting: Ireland – IrishJobs – Advanced
Company Trade Name:MSD
Job Segment: Microbiology, Medical, Medical Technologist, Manager, Pharmaceutical, Science, Healthcare, Management