External Site Quality Lead (ESQL) API
MSD Switzerland
πριν από 6 μέρες


Are you ready to Invent, Impact, Inspire?

Join MSD and shape the future of healthcare in Ireland


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.


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 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 are hiring an External Site Quality Specialist ( API) to support EMEA / North America. The role will sit within the External Quality (API) organisation and report to the Director of External Quality API.

The successful candidate will possess a unique combination of analytical, scientific, business and diplomacy skills in order to effectively manage and control all activities necessary for support of a Quality Operations program to manufacture, test, package, store, and distribute, API intermediates and API’s.

They will receive guidance on policy issues and direction with regard to operations, but function independently. The location of the role is flexible within Europe or North America.

Activities include :

  • Responsibility for oversight of Contract Manufacturing Operations API / intermediates for one or more External Parties (EP’s) with the assurance that the goods were produced in conformance to all applicable policies and procedures of MSD and compliance with all governing regulations.
  • Responsibility for Quality Control functions including oversight for product testing, as well as other relevant components as determined by applied calibrated Quality oversight.
  • Incorporates strong risk management principles including special focus on data integrity at the EP and supports the end to end risk network risk management program (E2E) and the quality risk management (QRM) program.
  • 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.
  • Ensures permanent audit readiness, regulatory inspection support and monitoring, effective complaint management, change control oversight, metric review, and review of annual product reviews.
  • This also includes providing support to build effective quality systems at the partner and supporting continuous improvement activities.

  • Serves as an EQA and Manufacturing Division 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 Manufacturing Division.

  • Reviews all audit outcomes pertaining to the EP and ensures appropriate and timely corrective actions are identified and implemented.
  • 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.
  • Conducts quality due diligence assessments for pre-approval considerations of new EP’s or introduction of new products.
  • Develops presentations for Quality Council meetings.
  • Coordinates significant investigations including Fact Findings and product recalls as needed.
  • May act as the regulatory compliance liaison on MSD’s behalf to interface with regulatory agencies.
  • Build and maintain strong relationship with external parties, operations, technology and procurement.
  • Closely collaborates with appropriate business and functional areas to conduct Tier meetings, Joint Steering Committee meetings and Business Review Meetings to achieve Manufacturing Division and MSD objectives.
  • In addition to supporting the quality operations activities at the external partner, s / he will support the execution of Strategic Initiatives related to compliant supply, operationalizing quality and developing an engaged and capable workforce.
  • Qualifications

  • BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) preferred.
  • Minimum of 5 years’ experience in the pharmaceutical industry including API experience with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
  • Competent in analyzing complex product, production and testing issues and have demonstrated scientific problem solving capabilities.
  • Possess strong compliance mindset, demonstrated interpersonal skills, including leadership and coaching, motivation, communication and negotiation.
  • Some level of contractual and financial awareness is required.
  • 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.

    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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