Bristol Myers Squibb QA Tech Ops Projects 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.
Quality Assurance Tech Ops Projects Lead
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. This role will be responsible for driving process improvements within the Quality Assurance Technical Operations Team as well as support through review and approval of investigations, change control records, and technical protocols as needed. 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 materials, manufacturing, laboratories, 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.
Participates as requested in the response team for audits and inspections by world health authorities.
Receives little supervision and identifies and reports and discrepancies from normal practices or procedures to management, recommending and implementing corrective actions.
Represents QA in cross functional meetings and makes sound decisions by exercising judgment within generally defined practices and policies, and applies appropriate notification to management as appropriate
Drives opportunities for continuous improvement through project leadership, Quality systems program ownership, and group engagement.
Provides training on QA owned procedures.
May provide guidance to less experienced staff.
May have direct supervision of non-exempt and/or exempt staff.
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 leading cross functional initiatives from concept to closure.
Strong Project Management skills required.
Experience with Continuous Improvement tools such as Six Sigma, Lean, DMAIC.
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.
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 firstname.lastname@example.org . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol Myers Squibb
Req Number: R1564584
Updated: 2022-11-27 04:49:02.994 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.
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