Sr. Spclst, External Manufacturing

Job title: Sr. Spclst, External Manufacturing

Company: MSD


Job description: Job DescriptionAbout the RoleAn amazing opportunity has arisen for an External Manufacturing Operations Senior Specialist. This role is essential in ensuring customer demand is met through a seamless partnership with our External Partners. You will be accountable for excelling in compliance, supply management, continuous improvement, and cost efficiency through effective leadership and coaching of cross-functional teams.What you will do:

  • Relationship and Team Management: Oversee the company’s relationship with External Partners and lead the Focus Factory Team, promoting collaboration among cross-functional members from Supply Chain, Quality, Technical Operations, and Procurement while championing diversity and inclusion.
  • Strategic Planning and Compliance: Develop and align annual relationship priorities with company strategy, ensuring compliance with quality standards like Quality Risk Management and Change Control while driving operational excellence in production planning and resource management.
  • Risk Assessment and Resolution: Proactively assess risks across the value chain, managing disputes and technology issues, and ensuring effective oversight of shop floor operations to mitigate risks and maintain quality and safety standards.
  • Performance Monitoring and Improvement: Conduct site evaluations through GEMBA walks, lead Continuous Improvement and Lean Six Sigma initiatives, and prepare annual performance reports that summarize successes and lessons learned in external relationships.
  • Collaboration on Commercial Aspects: Engage with External Manufacturing Procurement, Quality, and Technology on partner selection, contract negotiations, and capacity assessments to ensure alignment with operational needs and improvement strategies.
  • Inventory and Agreement Management: Maintain the integrity of the Master Supply Agreement and oversee inventory control, documentation, and material disposition while supporting strategic initiatives and contributing to the development of the External Manufacturing Organization Handbook.

What You Bring:In order to excel in this role, you will more than likely have:

  • Educational and Professional Qualifications: Bachelor’s degree in Engineering and/or Science, with a minimum of 5 years’ experience in commercial/business and manufacturing roles (operations, quality, technology, planning), including at least 3 years of operational experience in a manufacturing environment (ideally in Active Pharmaceuticals or equivalent), with a focus on Execution Excellence.
  • Proven ability to achieve compliance goals through a risk-based approach, with a deep understanding of Good Manufacturing Practices (GMP), Environmental Health and Safety (EHS) compliance, and quality compliance risks; direct experience with Health Authority audits is desirable.
  • Demonstrated Lean Six Sigma capabilities to deliver compliant supply while achieving the highest quality, lowest cost, and shortest lead times, along with strong business and financial acumen to inform strategic business decisions.
  • Proven management-level expertise in manufacturing modalities (API, Drug Product, Sterile) and the ability to visualize and identify strategic opportunities that add value and mitigate risks across the value chain.
  • Excellent interpersonal, communication, collaboration, and negotiation skills for effective cross-boundary work
  • Willingness to travel 25% to 50% for new product introductions, including potential shift and weekend work as needed.

Why Join Us?As a company, 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.We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.So, if you are ready to make an impact in manufacturing please apply today.Current Employees applyCurrent Contingent Workers applySearch Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements: RemoteShift:Valid Driving License:Hazardous Material(s):Job Posting End Date: 04/8/2025*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Expected salary:

Location: Dublin

Job date: Thu, 27 Mar 2025 00:32:07 GMT

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