Manager, Clinical Supply Chain QualityWorking with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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 with the resources to pursue their goals, both at work and in their personal lives.
The Role BMS External Manufacturing is looking to recruit on a permanent Contract Manager, Clinical Supply Chain Quality, reporting to Director, Clinical Supply Chain, QP.
PDQ Good Manufacturing Practice (GMP) serves as the Quality Assurance Unit overseeing manufacture, testing and distribution of clinical supplies (investigational products) to assure quality and compliance with Good Manufacturing Practices (GMP) and other applicable regulations and internal procedures.
Key Duties and Responsibilities: Compiles Qualified Person batch release dossiersSupports Packaging & Labeling activities performed at EUWH.Provides Quality Assurance support in the Use Date Extension process.Provides Quality Assurance support (GMP/GDP guidance and training) for CSO Regional Logistics.Support in a timely manner, the investigations of non-conformances and quality incidents. Resolves and documents into Quality Management System deviations or problems pertaining to the review of documents. Conducts appropriate follow-up as required. Tracks deviation, investigations and CAPAs.Authors ISR related Quality agreements, keeps agreements current and manages updates required.Prepares release dossiers for ISRsPrepares and reviews procedural documents as requested by supervisor.Support preparation of training materials.Contribute to improving and maintaining CSCQ QMSPrepare and approve supply chain flow maps, and product specification files.Authoring, review, and approval of QA-related proceduresSupporting generation of/updates existing Quality Agreements.Adherence to BMS core behaviors(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)Qualifications, Knowledge and Skills Required: Science, engineering or Pharmacy degree or similar required.At least 3 years' experience, 5 years' experience preferred, in biopharmaceutical/pharmaceutical industry.Experience in Pharmaceutical Industry Quality function a preferenceExperience in EU release of Pharmaceutical or Biopharmaceuticals a preferenceStrong knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes and principles of Quality AssuranceProven ability to learn quickly and keep up to speed in fast paced work environment.Proven clear communication supporting delivery for the business.Proven ability to continually work to improve services, and work processes.Proven ability to contribute as part of a team.Proven ability to influence others.Proven ability to work under pressureTravel may be required for this position and is anticipated to be approximately 10% of the time.Why you should apply You will help patients in their fight against serious diseasesYou will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.You'll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 27 days annual leave, access to BMS Cruiserath on-site gym and life assurance.
#J-18808-Ljbffr
