EQA Vaccines Platform Lead

Encontrado en: beBee S ES - hace 3 semanas

Madrid, España MSD A tiempo completo

Job Description


Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.


We are currently seeking an External Quality Assurance (EQA) Vaccines Platform Lead (m/f/d) to provide Quality oversight for manufacturing, testing, storage, and distribution of vaccine products at external entity sites in the Asia-Pacific (AP) and Middle-East-Africa (MEA) regions. Establish and maintain effective relationships with external partners to ensure reliable supply of company products in accordance with all applicable regulatory requirements, filings, policies, and procedures.


Conduct due diligence audits and technical assessments to inform external entity selection decisions.


Provide subject matter expertise in sterile manufacturing best practices, quality management systems, vaccine technologies, and regulatory requirements. Work independently and lead complex, cross-functional initiatives to optimize Quality and business processes at both company and external sites. The incumbent may also serve as a representative of the company in external forums.


Main Responsibilities


  • Manage all aspects of end-to-end external entity performance and serve as the primary contact for the relationship
  • Establish clear expectations, measures, and periodic monitoring of operational and quality performance for each external entity in the platform
  • Lead quality due diligence assessments for pre-approval consideration of new external entities (contract manufacturing or alliance partners)
  • Lead significant manufacturing and laboratory investigations, inclusive of fact findings and regulatory notifications as required
  • Establish and maintain Quality Agreements and contracts
  • Effectively engage, both in person and virtually, with a global, multi-cultural team
  • Serve as member of the EQA Vaccines Leadership Team, supporting shared business objectives across all global platforms
  • Contribute to development and adherence to annual budget and efficiencies
  • Demonstrate company Leadership Behaviors in all interactions with company and external personnel
  • Collaborate with other functional teams to continuously improve quality and business outcomes

Minimum Education Requirement


  • Bachelor Degree in a Science, Engineering, or related areas of study

Required Experience And Skills


  • Minimum of five years’ relevant experience in the pharmaceutical industry and/or biotechnology industry
  • Minimum five years' sterile manufacturing experience, preferably supporting drug product
  • Communicates in English, both verbally and in writing
  • Must have strong interpersonal, communication, coaching, and negotiation skills to build strong relationships
  • Prior people management experience preferred

The role can be based in any of our locations in the US or EU


The Company


Our company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been established in Zurich, aimed at accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our mission to save and improve lives around the world.


We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us.


Who We Are …


We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.


What We Look For …


Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact 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.

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