Bristol-Myers Squibb Company

Manager, Quality Engineering, Device and Combination Product Quality

Location
New Brunswick, NJ, United States
Posted
Sep 08, 2019
Ref
R1517112
Required Education
Bachelors Degree
Position Type
Full time
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Summary:

The Manager, Device and Combination Product Quality, New Brunswick Quality Operations is responsible for QSR quality and compliance oversight of Device and Combination Product Quality. The incumbent will ensure that devices used in combination products are maintained post approval and manufactured in accordance with regulatory and customer requirements and will be responsible for maintaining the design controls, commercial product support and supplier management processes. Represents QA function to ensure product design requirements are documented and maintained per design control requirements. Support post market activities associated with combination products. This position is responsible to (i) review design control deliverables and ensure that appropriate design control processes are implemented during life cycle management activities, (ii) ensure that appropriate risk management principles are incorporated, executed, and documented during the life cycle management of the product, (iii) review and approve design control documents including risk management documents that are associated with medical device/combination products, and (iv) support site and above site quality and compliance activities for device and combination products (e.g. investigations, complaints, etc.). Review upcoming regulations and facilitate remediation activities. Additionally, the position will support audits of device component suppliers, external design houses, service providers, and contract manufacturers as an SME.

Major Duties and Responsibilities:

The Manager, Device and Combination Product Quality has job responsibilities that include but are not limited to:

  • Collaborate with Device Development and Device Packaging Technology to ensure that all Design Control and Design History File activitiesare compelted and translated into the DHF and are in compliance with Design Controls and the relevant elements of the health authority requirements.
  • Provide above-site quality oversight and support to Device and Packaging Engineering and Global Procurement.
  • Ensure inspection readiness. Support inspections of Device technical teams and GPS sites. As needed support periodic audits of device component suppliers, external design houses, service providers, and contract manufacturers.
  • Represent Device Quality on medical device/drug or biologic combination product post approval teams as needed. Work with cross-functional teams to assist in the development of engineering studies, design verification protocols, stability studies and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans.
  • Author or coordinate the writing of comprehensive quality system documents. Initiate, update, review, or assist in the drafting of the quality manual, policies, directives, standard operating procedures and work instructions.
  • Ensure risk management is executed through Risk Management Plans, Risk Files, Hazard analyses, and risk analyses eg dFMEA, pFMEA, uFMEA etc. throughout the life cycle of the product. Ensure management oversight of RM activities.
  • Participate in Design Reviews for (e.g. new or existing) product teams as the Quality expert, reviewer and approver.
  • Ensure the Design History File is complete by tracking deliverables and milestones for commercial combination products.
  • Generate, update or assist in the drafting of policies, procedures, and work instructions related to product quality metrics (eg, risk assessment for product quality complaints, product quality complaint surveillance thres hoIds).
  • Ensure medical device/drug quality metrics are tracked and trended.
  • Provide internal or external training, as needed.
  • As requested, serves as a subject matter expert for quality events related to the development, manufacturing and packaging of medical device and combination products.
  • Reviews and approves change control proposals as required, deviations, investigations, and corrective action/preventive action reports as part of quality support. Support evaluation of changes (component, product, process) post design transfer for impact on manufacturing process, documentation and design control elements.

Serve as SME for evaluating the impact and applicability of new device/combination product regulations via the PEARL process by overseeing activities performed by personnel with QMS Lead responsibilities.

Education:

The position requires a minimum of a Bachelor of Science degree. A life science degree is preferred, e.g., Pharmacy, Chemistry, Biology, Engineering.

Experience/Knowledge
  • Direct Quality unit responsibility for the development and commercialization of medical device/drug or biologic combination products.
  • Minimum of 7 years experience in medical device/drug combination product development and manufacturing role, in a Quality, Technical, or Regulatory position or a combination thereof.
  • Direct experience in supporting commercial manufacturing sites and HQ groups through global health authority inspections.
  • Experience in Quality System Regulation, Part 4, Combination Product Guidance and CGMP.
  • Demonstrated experience leading and contributing through influence and working in cross functional teams to investigate and manage quality and compliance related issues.
  • Demonstrated ability to make and act on decisions while balancing speed, quality, and risk.
  • Knowledge in combination product design, development, and manufacturing, Quality Assurance, Validation, Technology Transfer, Supply Chain, Packaging, Surety, and Logistics.
  • Ability to think clearly and in a decisive manner; remain calm under adverse conditions.
  • Indepth knowledge of Quality system principles and applications
  • Demonstrated ability to work independently and with groups of people/teams in a complex changing environment.
  • Excellent oral and written communication skills.
  • Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments.
  • Ability to provide innovative, compliant ideas or alternatives that create value including seeking new information and external insights.
  • Pragmatic in approach with demonstrated ability to make sound, risk based decisions
  • A minimum of 2 years of CGMP/QSR auditing experience, preferably certified device auditor (e.g., ISO RAB, etc).
  • In depth knowledge of product attributes as they relate to regulations.


Skills/Competencies
  • Knowledge of effective styles of communication, change management, and leadership.
  • Ability to analyze and solve complex problems.
  • Ability to work independently and use initiative.
  • Ability to prioritize work and rapidly change priorities when necessary.
  • Ability to develop win/win solutions.

Ability to effectively manage difficult people and situations

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 the resources to pursue their goals, both at work and in their personal lives.