QA Manager

Req #: 1801533
Location:Boudry, NeuchatelCH
Job Category:Quality
Work Location: Route de Perreux 1 BOUDRY 2017
Organization: Celgene International SaRL
Schedule:40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:Switzerland- Boudry

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

The QA Manager will report administratively and functionally to the Director, QA Operations of Celgene Europe.

The primary role of the QA Manager is to perform routine quality assurance tasks and activities ensuring compliance with all regulatory and corporate requirements in support of Quality Operations for the Celgene Ext QA and EU Qualified Person function with particular focus of vendor quality oversight activities.

Direct management of QA professionals as assigned, performing line manager activities and supporting and developing reportees.

In addition, this position will assist in the development, organization, and execution of the Quality Assurance Management system of Celgene Ext QA within the Global Quality Organization which will ensure product quality and compliance with all regulatory and corporate requirements for Celgene Products within Europe and Rest of World Markets as applicable.

Responsibilities include, but are not limited to, the following:

For the assigned products and area of International Quality Operations:

• Manage and oversee for assigned Contracted Service Providers quality assurance activities to ensure product is manufactured, packaged, tested, released and distributed in compliance with all regulatory and corporate requirements.  This includes:
  
  
  
  • Building and maintaining good working relationships with the contractor
  
  
  • Leading discussions with the contractor on quality related topics, such as complaints, change control, deviations, OOSs, processes, methods, procedures, documentation, etc.
  
  
  • Approving master production/packaging records
  
  
  • Recommending quality related improvements to the contractor
  
  
  • Overseeing completion of contractor quality related activities, such as process, method and procedural improvements, quality investigations, corrective and preventive actions, etc.
  
  
  • Review batch records, both master production/packaging records and executed batch records ensuring compliance with GMP and registration requirements.
  
  
  • Preparation of batch documentation and associated quality assurance activities in support of Qualified Person certification
  
  
  • Handle change control requests as assigned. This includes, as necessary:
  
  
  • Initiating and approval routing of change control requests
  
  
  • Performing QA evaluation and endorsement/approval
  
  
  • Review of associated contractor change control requests
  
  
  • Monitoring progress of related action items
  
  
  • Escalation of change controls to Global Change Control as required.
  
  

• Process product complaints as assigned. This includes, as necessary:


• Recording complaint details


• Initiating and coordinating manufacturing investigation


• Communicating conclusions on investigations

• Review, edit, negotiate improvements to, and approve contractor documentation, including:


• Process validation protocols and reports


• Transfer validation protocol and reports


• Investigations, Deviations, OOSs

• Conduct review and approval of non-routine quality investigations related to batch deviations, batch disposition, validation activities, stability results, critical quality complaints, returns and other quality systems for assigned products
  
  
  
  • Support the compilation of Product Quality Review reports and provide reviews as necessary.
  
  
  • Develop and maintain Reference Master Files.
  
  
  • Draft or review, negotiate with contractors, and recommend approval for Quality Agreements.
  
  
  • Participate in self inspections as appropriate.
  
  
  • Participate in external audits of contractor manufacturers and distributors as assigned.
  
  
  • Ensure logs, databases and files related to the product quality activities are maintained.
  
  
  • Performance of trend reviews and compilation of metrics.

    For non-product related duties:

  
  
  • Support development and improvement of global quality management systems, as assigned.
  
  
  • Supervise and develop reportees
  
  
  • Author and/or revise standard operating procedures and associated work instructions, as assigned.
  
  
  • Review and provide recommendations on policies and standards, as assigned.
  
  
  • Support GMP/GDP site inspections, as assigned.
  
  
  • Maintain compliance with personal training requirements.

    Skills/Knowledge Required

  
  

• BS (or equivalent) in a technical or scientific discipline.


• Demonstrated pharmaceutical quality experience (equivalent to a minimum of 7years experience), including audit, batch record review, change control, complaint handling and investigations experience.


• Must have thorough knowledge of pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements (US and EU, particularly) ideally with experience of both sterile products and solid dosage forms.


• Must have demonstrated understanding of the processes and interactions essential for ensuring and maintaining regulatory compliance.


• Must have strong task management skills with the ability to prioritize, schedule, and control multiple projects and resources simultaneously under tight deadlines.


• Must have excellent communication skills, including excellent written, interpersonal, collaboration, and negotiation skills, with a team oriented approach.


• Must have demonstrated supervisory skills