QA Compliance- Associate Director
Merck Sharp & Dohme Corp.
Carlow, IE
12d ago

QA Compliance- Associate Director Job

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Enter your email to apply Requisition ID : QUA006898

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.

MSD Carlow are looking to recruit a QA Compliance - Associate Director, who will play a lead role in our quality team on site.

This role will manage a team of Quality Assurance Specialists and Senior Specialists. They will be responsible for all people aspects, such as coaching, talent development, recruitment and performance management.

This position is critical to ensure sustainable compliance of site processes, procedures and systems with our Manufacturing Division requirements and regulatory requirements and expectations.

The successful candidate will manage the following activities :

  • Serve as primary contact for regulatory agency inspectors. Lead the development of responses, CAPA implementation and effectiveness checks.
  • Manage the site auditing program.
  • Ensure recalls are executed as decided and appropriate agencies and contacts are notified in accordance with defined procedures.
  • Ensure that all regulatory commitments and related reporting are generated and submitted to the appropriate department or Regulatory Authority in accordance with established procedures.
  • Verify data and information in regulatory submissions and regulatory responses for quality, integrity and accuracy.
  • Manage site quality agreements with external and internal partners in line with established procedures. Contribute to the creation of quality agreements for multiple sites or on global level for such quality agreements that are relevant for the site.
  • Ensure that a system is in place to manage CAPA activities including generation, investigation, documentation, implementation, verification, closure, effectiveness, and trending.
  • Ensure that a system is in place to manage complaints handling and investigations and ensure its effectiveness.
  • Oversee and manage all data integrity activities of the site.
  • Education :

  • Third level qualification (Degree) in a Science or Techncial related discipline
  • Project Management qualification such as, Project Management Professional.
  • Evidence of Continuous Professional Development.
  • Preference for Lean Six Sigma Green Belt
  • Experience :

  • Minimum of 10 years’ experience in the FDA and / or EU regulated pharmaceutical environment; preferably in a manufacturing site in quality and / or manufacturing roles, which includes significant leadership roles with experience in a front-
  • line supervisory role in operations environment.

  • Demonstrated in-depth knowledge of global health authority regulations and quality and compliance requirements with the ability to effectively communicate these requirements.
  • Knowledgeable in Industry Best Practices for quality and compliance related topics.
  • Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and implementation of best practices across the site and Compliance functions on global and local level.
  • Proven ability to effectively initiate and drive change across the site.
  • Strong verbal and written communication skills, project management skills.
  • Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
  • Demonstrated ability to make and act on decisions while balancing speed, quality and risk.
  • Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.
  • 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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