Quality Operations Associate Manager/ Deputy of the Responsible Person
Bristol-Myers Squibb
Cham,Switzerland
vor 2 Tg.

Bristol-Myers Squibb is a global

Biopharma company committed to a single mission : to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development.

Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Position Summary :

The Deputy RP supports the RP to ensure quality assurance related compliance with all relevant national and international regulations issued by the relevant authorities as well as with BMS internal guidelines and its Quality Management System (QMS).

Key Responsibilities and Major Duties :

  • Act as Deputy of the Responsible Person (Fachtechnisch verantwortliche Person - FvP) for Manufacturing and Trade Abroad of non-ready- and ready-to-use medicinal products in accordance with the Swiss law on Medicinal Products
  • Disposition (release or reject) medicinal products independently from management and commercial functions
  • Ensure that the released batches of the medicinal products manufactured under oversight of and traded by the Swiss Branch of Swords Laboratories meet the specifications in force and are manufactured and transported in accordance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)
  • Provide review of and input to deviations, changes and quality complaints
  • Qualification of customers supplied with pharmaceutical products
  • Support the development and implementation of local procedures according to national and international regulations and BMS QMS
  • Participate in local and global quality and business related meetings to ensure alignment of activities
  • Provide support to the Quality Operations and to the wider Supplier Relationship Management, Global Procurement, Supply Chain and Manufacturing Science and Technology teams in support of projects, technical transfers programs, supplier selection programs, etc.
  • Support the preparation and update of Quality Agreements with internal and external manufacturers, laboratories and customers supplied with pharmaceutical products
  • Required :

  • Master's Degree in Pharmacy, Chemistry, Biology, Chemical Engineering or equivalent
  • Minimum of 5 years' experience in the pharmaceutical industry, with solid quality and compliance experience
  • Practical experience in manufacturing batch records review, product and / or shipment release
  • Experience in Quality Systems and Quality Assurance including good knowledge of GMP, GDP, ICH and other quality guidelines and standards, and ability to interpret and apply them
  • Good computer literacy (Microsoft Outlook, Word, Excel, PowerPoint)
  • Strong interpersonal communication (both verbally and in writing), collaborative and leadership skills in dealing with a broad variety of cultures
  • Demonstrated ability in technical writing and communication skills
  • Ability to work in a matrix organization in virtual international environment
  • Experience with GMP / GDP applications such as ERP, SAP, TrackWise, etc.
  • Fluency in German and English
  • Ideal Candidates Would Also Have :

  • Previous experience as Responsible Person (RP) or Deputy RP
  • Experience in bio-pharmaceutical manufacturing and / or regulatory area
  • Demonstrated technical expertise in conducting investigations, developing effective CAPA and use of risk assessment
  • Direct experience in interacting and effectively communicating with Health Authorities, managing Health Authority inspections
  • Ability to be decisive and influence management with demonstrated leadership skills to drive change
  • Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

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