Senior Specialist, QA Manufacturing Operations

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Summary BMS Cruiserath Biologics is seeking to recruit a fixed term contract (FTC) Senior Specialist, QA Manufacturing Operations. Reporting to the Senior Manager, QA Manufacturing Operations, the Senior Specialist, QA Manufacturing Operations will support the execution and maintenance of the QA activities related to Manufacturing operations and site operations on extended days shift (12/7) in Cruiserath.

QA support of manufacturing operations (commercial operations and new product introductions) Batch record review and on the-floor support of manufacturing activities QA Operations review of events and investigations Authoring, review and approval of QA-related procedures Review and approval of functional area documentation Support the Disposition process for Drug Substance Participation in GMP reviews for new facility construction and new equipment support systems QA support for implementation of Manufacturing Execution System (MES) and development of batch records QA support for implementation for Automation changes QA support for validation activities QA support for implementation of the BMS Enterprise Resource Planning System (SAP) including data verification and integration testing for the Quality function Change control assessment and CAPA evaluation/CAPA close-out Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements. Support OpEx programs and champion continuous quality improvement initiatives. Participate in the product recall and health authority notification process in accordance with BMS procedures. Engage in Quality Culture initiatives This is a 12/7 shift role.  Qualifications & Experience BSc in Science or related discipline 2 years’ minimum QA or related experience in a pharmaceutical environment A clear understanding of cGMP requirements for manufacturing and/or systems and compliance Required to work on his/her own initiative in addition to working as part of a team, and must be open to shift work. Must be able to work across a team matrix in order to meet accelerated timelines Excellent communication and presentation skills are essential Excellent time management and organisational skills along with a proven ability to multi-task Employees are expected to display the BMS Biopharma Behaviours, which enable them to be successful and perform at their highest level 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 We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway. How We Work Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a