Associate Director, Device and Combination Product Quality

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 Associate Director, Device and Combination Produt Quality is responsible for QSR quality and compliance oversight of Device and Combination Product Quality. Under the general guidance of the Director Device, Combination Product and Packaging Quality, the Associate Driector Device Quality will lead efforts to support the development of devices and combination products. The incumbent will ensure that devices used in combination products are designed and developed and manufactured in accordance with regulatory and customer requirements and will be responsible for maintaining the design controls, development program product support and supplier management processes. Represents QA function to ensure product design requirements are documented and maintained per design control requirements He/She will serve as Quality Assurance representative of drug-device combination products in development and enagage regulatory personnel to ensure filing pathways and requirements are determined in a timely manner. This position is responsible to (i) review design control deliverables and ensure that appropriate design control processes are implemented during product development activities, (ii) ensure that appropriate risk management principles are incorporated, executed, and documented during the the development of the product and (iii) review and approve design control documents including risk management documents that are assoicated with medical device/combination products. Support IDE & Clinical Supply Team, provide feedback and communicates status. Support CMC assembling and review for combination products HA applications and are maintained in compliance with applicable cGMP regulations and BMS standards. 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 Associate Director, Device and Combination Product Quality has job responsibilities that include but are not limited to:

• Responsible Device Quality lead on medical device and combination product developmental teams including leading the quality related workstreams.
• Quality approver for Design Reviews (e.g. new or existing) and ownership of design control documentation. Serves as Quality expert, reviewer and approver. Assure all activities are in compliance with Design Controls and the relevant elements of the Quality System Regulations, with emphasis in site and corporate change control procedures for combination products and processes.
• Responsible for the development and adherence to Device Validation Master Plan for combination products in accordance with established regulations and approved standards and procedures
• Ownership of Quality Plans for the new combination products and ensure this plan is transferred appropriately to manufacturing site.
• Quality lead for HA meetings that are facilitated by GRS-CMC for combination products under development.
• Oversight of all quality activities that support commercialization of combination products (i.e., complaints process set up of new failure modes, MDR reportability recommendations etc.)
• Collaborate with Device Development and Device Packaging Technology to ensure that all Design Control and Design History File completed and translated into the DHF and are in compliance with Design Controls and the relevant elements of the Quality System Regulations
• Ensure inspection readiness. Support inspections of Device technical teams and GPDS sites. As needed support periodic audits of device component suppliers, external design houses, service providers, and contract manufacturers.
• 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. Review and approval of test methods, protocols and reports related to Combination Products.
• Oversee the authoring of comprehensive quality system documents including 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.
• Ensure the Design History File is complete by tracking deliverables and milestones.
• Responsible for medical device/drug quality metrics as required.
• Support Management reviews by developing and compiling input from different stakeholders.
• Provide internal or external training, as needed.
• As requested, leads investigations and serves as a subject matter expert for quality events related to the development, manufacturing, packaging, storage, transportation and distribution of medical device/drug or biologic combination products. Support root cause analysis activities for major manufacturing investigations and product complaint trends across groups in MS&T, leading investigations related to device constituent portion of the combination products
• Support complaints investigation, complaints trending and adverse events reporting activities. Support root cause investigations for internal and external field complaints in a timely and effective manner
• 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) prior to and 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 10 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..
  • Experience in a pharma industry quality organization is a plus

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.