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Senior Manager, QA Commercial Manufacturing Operations

Company: Bristol Myers Squibb
Location: Devens
Posted on: May 31, 2021

Job Description:

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 Commercial Manufacturing Operations Senior Manager, provides supervision of process and personnel executing the release and allocation of drug substance, as well as shop-floor Quality activities. Assure the quality of manufactured products are in compliance with all applicable regulations and guidelines.

QA Commercial Manufacturing Operations - Senior Manager

  • Provides quality oversight of Quality disposition activities including change control reviews for impact to market allocation of drug substance, implementation of appropriate controls for market segregation, approval of procedures, and disposition recommendation of commercial bulk drug substance
  • Manage the drug substance material disposition schedule through effective staffing and prioritization
  • Reviews and approves drug substance disposition packages in accordance with SOPs for Quality Management signatory, as needed
  • Reviews and approves allocation of materials for forward processing and market-specific usage
  • Provides quality oversight of commercial manufacturing activities on a day to day basis, including direct oversight of QA field operations
  • Coordinates executed batch record review to ensure adherence to business target
  • Maintains schedule adherence and cycle time. Reports variances and communicates impact to cross functional groups.
  • Contributes to and supports the site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products
  • Hires, integrates and develops high quality talent, capable of delivering against the department goals and objectives
  • Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment enhances unit performance and integration across site department

Knowledge and Skill:

  • Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is required
  • A minimum of 8 years' experience in biopharmaceutical operations with 2 years of prior management experience desirable
  • Knowledge of biotech bulk and finished product manufacturing, Drug Substance or Drug Product disposition and batch record review is required
  • Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial biologics manufacturing is desired
  • Knowledge of US, EU and rest-of-world cGMP regulations and guidance
  • Knowledge and proven experience in FDA, EMA, or other regulatory authority.
  • Knowledge of applicable business systems including: SAP, LIMS, Maximo and Trackwise is required
  • Knowledge of manufacturing executions systems such as Syncade, SmartLab; and distributive control systems such as DeltaV is desirable
  • Experience in building and growing an organization into a high performance team
  • Demonstrated leadership, interpersonal, communication, and motivation skills
  • Excellent writing and oral communication skills are required

Contacts:

Incumbents have daily interaction with their staff and other members of the site Quality Assurance organization. Senior Managers have business needs to interact with any employee at any level of the Devens Facility with daily interactions with other Quality staff, Supply Chain, Digital Plant, Site Engineering and Manufacturing staff in support of disposition and allocation activities. Less frequent contact with general business functions including human resources, EHS and Finance and BMS staff at other locations, including corporate headquarters. Occasional contact with outside vendors and representatives from health authorities / regulatory agencies.

Working conditions:

Work is performed in a modern office environment and requires extensive computer work. Additionally, work is performed in state-of-the-art large-scale cell culture manufacturing facility, as well as support GMP areas, with environmental classified areas requiring appropriate personal protective equipment (PPE) and potential exposure to chemical hazards, pressurized gases and hot surfaces.

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

Keywords: Bristol Myers Squibb, Nashua , Senior Manager, QA Commercial Manufacturing Operations, Other , Devens, New Hampshire

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