||Aug 09, 2019
||3 yrs- 5 yrs
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.
• Provide Quality oversight for testing of clinical supplies (investigational products) to assure quality and compliance with Good Manufacturing Practices (GMP) and other applicable regulations and internal procedures.
• Coordinates the assignment of tasks to be performed by the assigned managers/Associates/Specialists.
• Assure the quality of manufactured products complies with all applicable regulations and guidelines.
- Conducts, plans, schedules, or supervises the review and approval of laboratory data, and other documentation as needed.
- Reviews and approves documents related to Quality Systems such as laboratory investigation reports (OOA, OOS), test method validation protocols or reports, test specifications, SOPs/WIs, change controls, raw material release, etc.
- Drafts and/or reviews Quality Agreements, as requested.
- Supports site operations during regulatory agency and third party inspections.
- Provides on-the-job training to Quality Operations personnel and GMP training to functional areas, as appropriate.
- Brings to the attention of the Quality Operations Management, any information relating to the impact of legislation on the functions of the department, system deviations, etc.
- Provides reports to Management related to timely CAPA implementation, as requested.
- Provides support to PD/DPST-Device Operations for overall quality system and review of protocols and procedures, as requested.
- Build and foster strong relationships and partnerships with stakeholders and support groups to meet the demands of a changing business culture and environment.
- Provides instruction and guidance on quality issues and serves as a resource for the site.
- Adherence to BMS core behaviors
Professional experience and qualifications
- Knowledge of science generally attained through studies resulting in B.S. or M.S. in chemistry, pharmacy or biology or a related pharmaceutical science
- A Ph.D. in a related science with 4-6 years of relevant experience within the pharmaceutical or healthcare industry, or a M.S. with 7-9 years experience, or a B.S. with 9-11 years experience; including 3-5+ years experience in a regulated function.
- Knowledge of biopharmaceutical analytical methods
- Experience within a QA/QC environment is required
- Technical expertise in resolution of deviations and development of effective CAPA
- Experience in Quality Management at development and/or commercial stage of pharmaceutical operations
- Broad experience in the manufacturing of sterile and non-sterile products
- In-depth knowledge of GMP regulations
- Strong problem solving, interpersonal and organizational skills
- Strong collaborative and influencing skills
- Effective written and verbal communication
- Computer literacy: Microsoft Office and SAP environment Trackwise®, PDLIMs, and other systems as required
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.