Manager, Quality Engineering, Device and Combination Product Quality
Company: Bristol-Myers Squibb Company
Location: New Brunswick
Posted on: August 4, 2019
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
- 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
- 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,
- Direct Quality unit responsibility for the development and
commercialization of medical device/drug or biologic combination
- 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
- 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
- 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
- Ability to provide innovative, compliant ideas or alternatives
that create value including seeking new information and external
- 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
- 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
- Ability to develop win/win solutions.Ability to effectively
manage difficult people and situationsBristol-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.
Keywords: Bristol-Myers Squibb Company, New Brunswick , Manager, Quality Engineering, Device and Combination Product Quality, Executive , New Brunswick, New Jersey
Didn't find what you're looking for? Search again!