Manager, Quality Assurance, Pharma QP Operations

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 .

POSITION SUMMARY

Bristol-Myers Squibb is looking to recruit a Manager, Quality Assurance to provide quality and compliance oversight support to Pharma QP Operations
This a 12 month fixed term contract position.

Qualifications & Experience

• Minimum 2 years experience in a regulated environment, preferably the pharmaceutical industry in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency.
• A BSc in a scientific discipline.
• Knowledge of cGMP regulations pertinent to the USA, EU and other international markets.
• Proven time management, organization and task prioritization skills.
• Ability to develop cross-functional and external working relationships.
• Strong communication and presentation skills.
• QP Eligible (desirable

• Directly support Qualified Persons within the QP team carrying out final release to market.
• Compile batch release documentation into QP pack for review by the QP.
• Complete QA Manager batch review checklists.
• Identify and resolve batch release documentation issues.
• Manage change controls, deviations and corrective actions associated with QP group activities.
• Generation and maintenance of Batch Certificate templates.
• Support cross-functional projects and continuous improvement initiatives.
• Generate and coordinate metrics programs in relation to QP group activities.
• Support QP activities relating to new product introduction, product launch preparation and technology transfer.
• Provide support as needed to the BMS Fact Finding (FF) and Product Review Committee (PRC) processes for major investigations involving Third Party products.
• Provide quality/compliance support as needed to the wider cross-functional Virtual Plant Teams.
• Provide quality support as needed to Global BMS functional groups such as Global Regulatory/CMC and the local country based regulatory managers in support of regulatory filings, product renewals, regulatory agency questions etc.
• Assist in the review of Quality Agreements with the Third Party Manufacturers and Alliance Partners.
• Support the Global BMS internal self-inspection program.

Qualifications & Experience

• Minimum 2 years experience in a regulated environment, preferably the pharmaceutical industry in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency.
• A BSc in a scientific discipline.
• Knowledge of cGMP regulations pertinent to the USA, EU and other international markets.
• Proven time management, organization and task prioritization skills.
• Ability to develop cross-functional and external working relationships.
• Strong communication and presentation skills.
• QP Eligible (desirable)

Why you should apply

• You will help patients in their fight against serious diseases
• You 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 of annual leave , access to BMS Cruiserath on-site gym and life assurance