Senior Manager/Associate Director, QC Engineering and Projects

Canton, MA

Job Req code: 988

Category: Quality Systems

We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. We offer a strong benefits package, opportunities for growth, and the chance to contribute to our mission: to provide an integrated portfolio of healing solutions that improve lives.

This position has responsibility for leading and mentoring a team of QC engineering professionals engaged in supporting internal and cross-functional projects across all corporate locations, CMO’s, and contract testing laboratories as related to existing and new wound therapy product portfolios regulated as Class I, II, and III Medical Devices, Biologics/Combination Products, and HCT/Ps.   The candidate must have a strong ability and proven track record for developing strategies for solving a diversity of complex engineering, technical, and scientific problems within a CGMP environment while complying with applicable regulatory requirements.  CGMP experience with process validation, analytical development and validation, stability studies, extractable/leachable studies, sterilization and cleaning validations, design control, and authoring sections of CMC submissions, IND filings, and NDA submissions is required. This position reports to the Assistant Vice President of Quality Control and QA Compliance.

Key Responsibilities:

  • Develop and execute QC operational strategy in conjunction with cross-functional groups and senior leadership across all sites and CMO’s.
  • Provide strategic direction and articulate quality requirements to cross-functional project teams.  
  • Develop and lead a high-performing team, facilitating goal setting and development of direct reports in alignment with corporate goals and objectives.
  • Determine method validation requirements, author and/or approve method transfer and validation plans, protocols and reports
  • Lead QC method validations in support of the lifecycle management of QC methods for in process, release and stability methods as they are improved, replaced, and/or introduced
  • Lead Design Control program
  • Manage product stability study programs across sites, carry out stability trending with the goal of shelf-life setting
  • Author stability reports and batch/stability sections in IND and NDA filings
  • Conduct data review and ensure data accuracy for release test and stability results
  • Represent the quality control function through all phases of the design and construction of new state-of-the-art QC laboratories
  • Initiate and provide support and guidance for the resolution of investigations, deviations, CAPAs, change controls, and other quality systems issues, as appropriate
  • Maintain close coordination with QA and regulatory, as well as other CMC functions, clinical and medical regarding safety-related questions on formulations and materials used in processing
  • Author responses to inquiries from regulatory agencies.
  • Contribute to and/or author regulatory sections (PMA, BLA, and IND level) related to change controls including but not limited to process validations, material qualifications, specification development based on appropriate statistical analysis, method descriptions and method validations.
  • Proactively pursue continual improvement and procedural changes.
  • In collaboration with key stakeholders, oversee external vendors/contract testing facilities
  • Liaise with stakeholders to determine testing and shipping logistics
  • Interface with CMC teams, Quality Assurance, Regulatory Affairs, Medical and Clinical Affairs, Manufacturing, Process Development, and R&D.
  • Ability to navigate and be successful in a fast-paced, highly matrixed work environment

Requirements

Preferred Education and Experience:

  • BS, MS, or PhD in Engineering discipline (Chemical, Biomedical, or equivalent), Biotechnology, Materials Science, or Analytical Chemistry with 15+ years of diverse experience within the Medical Device, Biologics, Pharmaceutical and/or other relevant fields with 7+ years of direct QC management responsibility. 
  • Expertise with (bio)materials, analytical, bioassay, and novel method development, qualification and validation highly desirable.
  • Proven track record of having authored sections of CMC submissions and/or responses to requests for information that have gained FDA (or other agency) approval.
  • CGMP and FDA experience required.
  • Able to lift 50 lbs. and 40% of time standing in workday.

Other Skills/Abilities:

  • Strong analytical, problem solving and critical thinking skills
  • Solid understanding of regulations and standards related to 21 CFR Part 820, 21 CFR Part 210, 21 CFR Part 600, 21 CFR Part 1271, ICH guidelines, CGMP and ISO 13485 requirements.
  • Experience executing and validating analytical test methods (FTIR, flow cytometry, qPCR, cell counting, ELISA, cell-based bioassays, etc),
  • Managing all aspects of stability studies, extractable/leachable studies, cleaning validations, and sterilization validations.
  • Experience in establishing Quality Control laboratories
  • Strong knowledge of materials science with the ability to guide project teams on the appropriate selection, testing, properties, and/or biocompatibility of (bio)materials relative to the intended application.
  • Experienced, self-motivated individual who can handle multiple priorities to meet project team goals and timelines
  • Ability to interface effectively with management and other groups, project teams and personnel at manufacturing sites and CMO’s
  • Experience with analytical techniques including but limited to HPLC, LC/MS, GC, FTIR, XRD, DSC, ELISA, Flow Cytometry, RAMAN Spectroscopy, BCA, SEM, SDS PAGE, Western Blot
  • Strong understanding and working knowledge of statistical methods and software for establishing statistically appropriate specifications and/or limits
  • Experience in regulatory inspections
  • Open, available, and transparent communicator with strong leadership, presentation and influencing skills, and problem-solving ability
  • Excellent leadership skills to lead cross functional teams to ensure project success
  • Excellent interpersonal skills with ability to manage conflict effectively.
  • Superb written and verbal skills and the ability to communicate clearly, concisely, and effectively is a must