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Job Details


Bristol Myers Squibb

Senior Manager QA Operations (R1560370-en-us)

Operations

Security Operations

Yearly

No

Syracuse, New York, United States

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.

The QA Operations Manager is responsible for managing the Syracuse site quality release and quality investigation teams. The QA Operations Manager is responsible for managing the quality requirements of distribution of drug substance and cell banks to the biologics network, assuring documented evidence of quality to support disposition decision and assuring control of batch characteristics to distribute to various markets in alignment with regulatory approvals and commitments.

Duties/Responsibilities:

  • Manage a team of Quality department personnel to ensure on time release of manufactured materials (cell banks, drug substance, Intermediates). Ensure all release packages are in accordance with standard operating procedures for Quality Management signatory of approval. Responsibilities include updates to Drug Substance lot status in applicable quality systems.

  • Provide quality oversight of manufacturing floor and laboratory activities through approvals of; master batch records, standard operating procedures, change controls, deviations, and corrective/preventative actions.

  • Prepare and issue Certificates of Compliance and Certificates of Analysis where required.

  • Responsible for QA related issues for Cell Banks including obtaining final release as required.

  • Responsible for authorizing shipments of product from the Syracuse site including verifying the market the material is approved for use in and assignment of “Use By Date” or “Expiration Dates” where applicable.

  • Perform and manage QA review and approval of Quality and Manufacturing SOPs and batch records.

  • Provide oversight to Quality walkthroughs for shutdown and inspections readiness activities and ensures program management complies with site and corporate procedures.

  • Contribute to and support the site team, which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products.

  • Directly participate in internal audits or reviews as well as global health authority inspections. May include representation on inspection response and corrective/preventative action teams.

  • Hire, integrate and develop high quality talent, capable of delivering against the department’s goals and objectives.

  • Define and enforce performance measures, provide developmental feedback and coaching and create a collaborative environment enhances unit performance and integration across site departments.

  • Provide strategic foresight to identify and implement changes to enhance long-term goals of the department and drive operational excellence and process robustness.

  • This position will require daily contact with all production areas, Manufacturing Sciences and Technology, Facilities and Engineering and Quality Control Laboratories.

  • Establish and communicate performance objectives for Quality personnel that are consistent with the Quality and business unit goals.

Qualifications:

  • Minimum of a Bachelor’s degree in engineering, science, biochemistry or related discipline

  • At least 10 years experience in pharmaceuticals or biologics industry with at least 5 years of management in Quality Assurance, Supply Chain or related technical function and increasing cross-functional responsibility.

  • Strong knowledge of FDA, EU and ICH regulations and guidance and cGMPs.

  • Strong knowledge of supply chain principles.

  • Strong root cause investigation knowledge and experience leading quality and compliance investigations.

  • Strong project management and technical team facilitation skills.

  • Strong presentation, organization and technical writing skills.

  • Demonstrated leadership, interpersonal, communication and motivation skills.

  • Ability to understand topics which are often complex and technical in nature with an ability to apply sound judgment and appropriate quality risk management principles in the decision making process.

  • Strong communication skills and experience in preparing for and interacting directly with regulatory and external inspection auditors Syracuse Site .

  • Knowledge of biologics bulk and finished product manufacturing and analytical testing is highly desirable.

  • Knowledge of SAP, LIMS, Maximo and Trackwise or equivalent quality systems is needed

  • Knowledge of Delta V and Syncade is desirable Education/Experience/

  • Lean and/or Six Sigma green, black or master black belt certification is desirable.

  • Supply chain planning or management certification are preferred.

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.