Quality Operations – External Manufacturing – QA Senior Specialist

at  BristolMyers Squibb

WORKING 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. Read more: careers.bms.com/working-with-us.

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.
  If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Ensure BMS products are manufactured, packaged, tested, released, and distributed in compliance with all regulatory and corporate requirements; this includes but is not limited to:

• Building and maintaining a good working relationship with 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.
• 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 requirement

RESPONSIBILITIES

Support 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; this includes but is not limited to:

• Building and maintaining a good working relationship with 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.
• 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