QA Technical Operations Lead (R1551799-en-us)
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Bristol Myers Squibb is looking for a remarkable QA Technical Operations Lead to join our amazing team in Devens, MA! If you have strong quality assurance experience - this is your opportunity! As our QA Technical Operations Lead, you will provide Quality oversight and support for our Investigations Program. You will assure the quality of manufactured products is in compliance with all applicable regulations and guidelines. You will also support primarily through review and approval of investigations, as well as change control records and technical protocols. This role may assist in preparing for and hosting of regulatory and customer audits.
Provides quality support to Devens Site through quality review and approval of investigations and change controls.
Reviews and approves discrepancy reporting, investigations and corrections and actions associated with all areas of the manufacturing process including, incoming, manufacturing, facility, and utility systems.
Quality support of Quality Control laboratories, Technical Services programs, clinical product technical transfers, and equipment maintenance activities.
Participates as requested in the response team for audits and inspections by world health authorities.
Drives opportunities for continuous improvement through project leadership and group engagement.
Provides training on QA owned procedures.
May have direct supervision of non-exempt and/or exempt staff.
Role Qualifications & Experience:
Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
A minimum of 6 years of relevant experience in a regulated environment with at least 4 years focused on product quality.
Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.
Extensive knowledge of US and EU cGMP regulations and guidance.
Knowledge of Quality Risk Management principles preferred.
Knowledge of electronic systems including any of the following: SAP, Infinity (Veeva Vault), TrackWise, Maximo, DeltaV, and Syncade desirable.
BMSBL, BMSBLDMA, VETERAN
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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