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.
PURPOSE AND SCOPE OF POSITION:
This position is responsible for Quality Assurance (QA) tasks involved primarily with external manufacturing of Celgene product at Contract Manufacturing Organizations (CMO). The QA function ensures at contract manufacturing organizations the cGMP compliant execution of the API production processes. The Position provides Quality oversight for a selection of contract manufacturing organizations used for the manufacture, packaging and testing of Commercial Drug Substances in accordance with Celgene policies, procedures and GMPs and ensures Celgene drug substances are available for further drug product processing as required. The incumbent will cover multiple products at multiple Contract Service Providers (CSPs) related to drug substance manufacturing. The position holder will report to the Director QA Operations at Celgene Chemicals being responsible for the quality of internal and external API manufacturing.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
DUTIES AND RESPONSIBILITIES
The position holder is responsible for the tasks below related to external API manufacturing being under Celgene Chemicals’ QA oversight. The list of tasks is non- exhaustive, according to business needs other tasks might be assigned to this position.
Partners with Technical and Analytical Operations to identify and qualify manufacturing facilities for the Manufacture, Packaging and testing of Commercial Products. Serves as the Celgene Quality single point of contact for the assigned CSPs with responsibility for Quality and Compliance performance. Acts as QA Lead for new projects or new products to be implemented at assigned commercial vendors sites:
participates to project meetings as appropriate,
defines the necessary action plan for QA aspects,
coordinates the implementation of resulting actions with the vendor and within Celgene,
reviews (or coordinates the review) and approves associated vendor QA documentation as required,
communicates relevant vendor related QA information within Celgene as appropriate including liaison with project Technical Lead.
Provides active support to assigned vendors for QA compliance tasks through a close partnership with vendor's representatives Oversees the Vendor Quality Management Systems to ensure Deviations, OOS and CAPA are managed in a compliant and timely manner.
Deviations/OOS and CAPAs related to events occurring at manufacturing/testing sites: review/assessment (in collaboration with other internal experts as appropriate), feedback to vendor, communication to appropriate Celgene functions, follow-up
Oversees vendor change control process and ensures that Celgene products are manufactured in full compliance with all applicable regulations.
Change Control events from or to the vendor: review/assessment and follow-up in collaboration with appropriate Celgene QA functions and according to local /global change control process requirements including regulatory assessment; liaison with vendor, follow-up.
Communicates Specifications and changes of specifications to vendors, reviews and approves vendor resulting specifications, coordinates with vendor and Celgene departments as appropriate and ensures implementation of Celgene global specifications into the vendor’s quality system Partners with Technical and Analytical Operations to identify Quality and Compliance risks and develop / implement plans to mitigate via a risk management approach. Implement the process to achieve Vendor Quality Qualification with appropriate continued monitoring to ensure maintenance of status. Final Quality approver for all GMP documentation associated with Batch Records, Validation documents, Investigation Protocols etc. Responsible for final Batch Disposition decisions. Reviews vendor’s Product Quality Review (PQR) and compiles Celgene’s APR Creates and concludes Technical and Quality Agreements (TQA) Performs QA tasks triggered by regulatory submissions: assessment of requests/needs, liaison with vendor and Celgene departments as appropriate, preparation of necessary QA documentation. Performs QA tasks triggered by QC topics: assessment/review of requests/needs, approval of documentation as appropriate, liaison with vendor and Celgene QC as appropriate. Provides support to other Celgene departments concerning requests for investigation or information pertaining to assigned quality topics. Participates in Celgene Corporate Vendor Audits and visits to external manufacturers as assigned Develop Quality metrics as part of a balanced scorecard to assess ongoing monthly performance. Coordinates periodic QA meetings with vendor reps as assigned or participates in business review meetings to identify areas for improvement in partnership with vendor Reviews and updates procedures for the Quality Management System of Celgene as per process ownerships and business needs.
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Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.