Quality Assurance Specialist
vor 1 Monat
Transforming Patients' Lives through Science
Bristol Myers Squibb is a leading pharmaceutical company that is dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Quality Assurance Specialist to join our team in External Manufacturing.
About the Role
This is a challenging and meaningful role that requires a strong understanding of cGMP regulations and quality systems. The successful candidate will be responsible for ensuring that our products are manufactured, packaged, tested, released, and distributed in compliance with all regulatory and corporate requirements.
Key Responsibilities
- Support the Quality Operations Manager/Sr. Manager in the Contract Manufacturing Management in relation to quality assurance activities.
- Ensure BMS products are manufactured, packaged, tested, released, and distributed in compliance with all regulatory and corporate requirements.
- Oversee 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.
- Manage change control requests.
- Process product complaints.
- Support the review of Annual Product Quality Review reports, as necessary.
- Participate in self-inspections as appropriate.
- Participate in external audits of contractor manufacturers and distributors as assigned.
- Ensure quality metrics are always up to date, consistent and accessible to the Virtual Plant Team (VPT).
- Performance of trend reviews and compilation of metrics.
- Support GMP/GDP site inspections, as assigned.
- Maintain compliance with personal training requirements.
Required Competencies
- In-depth knowledge of cGMP/GDP regulations pertinent to the USA, EU, and other international markets.
- Ability to assess the right balance between business targets and scientific and quality decisions.
- Strong analytical and problem-solving skills.
- Ability to build relationships, partnerships, and influence and/or enforce quality decisions at external/internal sites as appropriate.
- Good communication and organizational skills.
- Project management skills.
- Development, organization, and execution of the Pharmaceutical Quality System of BMS within the Global Quality Organization.
- Must have computer proficiency.
Required Qualification(s) and Desired Experience
- MSc or equivalent in Bio-Science-Pharmaceutical disciplines.
- At least 5 years of experience in a pharmaceutical company (MS&T and Quality is preferred).
- Experience and technical knowledge in chemical, biological, and/or pharmaceutical operations which enables firsthand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences, and interface with research & development.
- Direct experience interacting with Health Authorities and supporting Health Authority inspections, specifically FDA, EMA, and/or Swissmedic.
- Experience in interacting with external manufacturers and supporting quality at external manufacturing sites.
- Business Fluent in English; French and German good proficiency is an asset.
Why Join Us?
Bristol Myers Squibb is a company that is dedicated to transforming patients' lives through science. We offer a unique and inclusive culture that promotes diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based, and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role.
Equal Employment Opportunity
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.
Covid-19 Vaccination
BMS strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
Application Process
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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