Bristol Myers Squibb QA Technical Operations Lead in Devens, Massachusetts
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 in Devens, MA is looking for an experience QA Technical Operations Lead to join our phenomenal team! As our QA Technical Operations Lead, you will provide Quality oversight and support for Manufacturing, Manufacturing Science and Technology, Technical Services, Automation, Validation, Quality Control laboratories, and Site Engineering projects. Assure the quality of manufactured products is in compliance with all applicable regulations and guidelines. Support through review and approval of investigations, change control records, and technical protocols. 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.
Assures consistent, effective use of the site change control system for all change requests. Ensures supporting documentation and change deliverables meet external regulatory and internal Global BMS guidelines and requirements.
Provides quality support and oversight for Manufacturing Science and Technology and Validation protocols and reports.
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.
May provide guidance to less experienced staff.
Drives opportunities for continuous improvement through project leadership and group engagement.
Represents QA in cross functional meetings.
Provides training on QA owned procedures.
Receives little supervision and identifies and reports and discrepancies from normal practices or procedures to management, recommending and implementing corrective actions.
Makes sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate.
May have direct supervision of non-exempt and/or exempt staff.
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, LIMS, Infinity (Veeva Vault), LES, Maximo, Vault and Syncade desirable.
Experience working in a team based environment with a diverse group of people.
Excellent writing and oral communication skills are required.
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.
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 any part of the recruitment process direct your inquiries to firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Company: Bristol Myers Squibb
Req Number: R1543945
Updated: 2021-08-03 02:57:11.811 UTC
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Bristol Myers Squibb
- Bristol Myers Squibb Jobs