Associate Director –External Site Quality Leader (ESQL) - External Quality Assurance (EQA) Sterile
MSD Switzerland
Portugal
há 6 dias

Description

Associate Director External Site Quality Leader (ESQL)

MSD Brinny

Are you ready to Invent, Impact, Inspire?

Join MSD and shape the future of healthcare in Ireland

INTRODUCTION

At MSD Ireland, we are committed to Inventing for Life’ in all that we do. 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.

THE COMPANY

MSD Ireland is one of the country’s leading healthcare companies, having first established here over 50 years ago.

We currently employ over 1,700 employees, across four sites in Ballydine, Co Tipperary, Brinny, Co Cork, Carlow and Dublin and, in addition, operate substantial Human Health and Animal Health businesses.

In total to date, we have invested $2.5 billion in our Irish operations and our annual turnover ranks us as one of Ireland’s top 20 companies.

Currently, our Irish sites manufacture approximately half of MSD’s top twenty products, saving and enhancing lives in over sixty countries around the world.

With almost 70,000 employees operating in more than 140 countries, you will be joining one of the world’s largest pharmaceutical companies.

MSD BRINNY

MSD Brinny is a leading facility for the development, testing and manufacturing of new biologics and vaccines, exporting to over 90 countries across the world.

With a team of approximately 500 people, MSD Brinny specialises in the late-stage development and commercial supply of biotech products, including some of the company's most successful and life-

changing treatments for oncology, hepatitis C and rheumatoid arthritis.

The Brinny site has been a vibrant part of the local Innishannon community for nearly 35 years and is now one of the region’s largest employers.

MSD has invested €130m in the site since 2016 as a result of increased global demand for MSD medicines and vaccines which will see MSD Brinny further expand its production facilities and capacity to meet this demand.

  • Responsibility for quality oversight of External Party (s) (EP) that manufacture sterile pharmaceutical products for MSD, ensuring that the goods were produced in conformance to all applicable policies and procedures of MSD and compliance with all governing regulations.
  • Prior to shipment 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.

  • 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.

  • Monitors efforts to improve the EP’s quality and reliability through ongoing oversight and formal communication programs and forums.
  • Provides support to the EP’s to facilitate and validate new product introductions
  • Will provide on site quality support for all Regulatory Authority Inspections at the EP.
  • Conducts quality due diligence assessments for pre-approval considerations of new EP’s
  • Coordinates significant investigations including Fact Findings and product recalls as needed.
  • Closely collaborates with appropriate business and operations areas to achieve Manufacturing Division and MSD objectives.
  • Assures the development and maintenance of a Quality Agreement with the EP. Provides input into the development of contractual agreements with the EP
  • Executes a program of calibrated Quality oversight based on the product type, capabilities, and quality and compliance performance of the EP.
  • Directs the EQA EU cGMP program including maintaining permanent inspection readiness at sterile EPs

    Qualifications

  • 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.
  • Experience in Contract Manufacturing Oversight (CMOs, Labs, etc.) required.
  • Quality Agreement negotiation and implementation skills are required.
  • Strong understanding of MSD Sterile Standards required.
  • Qualified Person (desirable but not a mandatory)
  • 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.

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    Search Firm Representatives Please Read Carefully :

    MSD is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails.

    All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and / or method without a valid written search agreement in place for this position will be deemed the sole property of MSD.

    No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.

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