• Job Description

  Req#: R289420

  Job Description

  A fantastic opportunity has arisen for a Senior Specialist - External Manufacturing Operations. within our Manufacturing & Supply Division This will be an EU based role, preferably based in Ireland or Lucerne.

  Bring energy, knowledge, innovation to carry out the following:

  • Ensure Compliance: You will be responsible for ensuring compliance with quality risk management, deviation management, product release, and change control processes.
  • On-site Presence and Relationship Building: You will maintain a presence at the external partner's site, either physically or virtually, to build a strong co-dependent relationship with the site's leadership team.
  • Risk Assessment and Mitigation: You will drive risk assessment across the value chain in close collaboration with the Focus Factory team and the external partner. This involves managing and mitigating risks to ensure an uninterrupted supply chain and 100% compliance with quality, environmental, health, and safety requirements.
  • Cross-functional Collaboration: You will participate in and represent External Manufacturing on cross-functional teams with supply chain management, product source management, procurement, and integrated development and supply teams.
  • Capacity Planning and Supply Agreement: You will work with the external partner to understand their capacity and future capacity plans. You will also be accountable for maintaining the integrity of the Supply Agreement, ensuring alignment with supply and quality agreements, and managing appropriate document revision and distribution control.
  • Inventory Control and Operational Excellence: You will be accountable for inventory control and ensuring adequate documentation of material disposition. Furthermore, you will act as the operational excellence leader and coach for your own team, working with external partners and lean manufacturing resources to identify and implement continuous improvement opportunities.
  • Business and Operations Review Meetings: You will support the Focus Factory Lead with periodic Business and Operations Review Meetings with the external partner.

  Skills you will need:

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

  • Bachelor’s degree preferably in the Engineering, Science or Business
  • Minimum 3 years’ experience in commercial / business and manufacturing (sterile operations, quality, technology, planning); Sterile Drug Product and /or Vaccines operations experience would be a distinct advantage.
  • Work Environment – Adaptability to work in remote setting with remote teams.
  • Compliance – Has experience and ability to achieve compliance goals, through a risk-based approach has a deep understanding of GMP and EHS compliance and quality compliance risk. Direct Health Authority Audit experience desirable.
  • World Class Supplier Mindset – Has experience with Lean Six Sigma skills to deliver compliant supply and achieve highest quality, lowest cost and shortest lead-time.
  • Strategic Thinking – Can Visualize the way forward, identifying opportunities that add value to the work and proactively mitigate risk across the value chain.
  • Working Across Boundaries – Must possess excellent interpersonal, communication, collaboration, negotiation skills to work outside boundaries as a norm.
  • Business Outcomes /Drive Results – Ability to use deep knowledge and expertise in production operations to drive results and business outcomes.
  • End to End Mindset – Ability to apply understanding of end-to-end supply chain within external and internal network and stakeholders across the network to achieve results and contribute supply chain optimization

  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.

  As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

  We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

  Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model

  So, if you are ready to:

  Invent solutions to meet unmet healthcare needs, please apply today.

  Current Employees apply HERE

  Current Contingent Workers apply HERE

  Search 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:

  Regular

  Relocation:

  VISA Sponsorship:

  Travel Requirements:

  Flexible Work Arrangements:

  Remote

  Shift:

  Valid Driving License:

  Hazardous Material(s):

• About the company

  Merck & Co., Inc.,

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