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Senior Director, Quality Compliance

Company: Vertex Pharmaceuticals
Location: Boston
Posted on: June 25, 2022

Job Description:

Job DescriptionGeneral Summary:The Senior Director, Quality Compliance, is a key leadership role in the Quality organization that will provide strategic leadership and direction to the advancement of the framework, capabilities, and sustainability of the compliance function in driving leading practices and keeping pace with the evolving organization and industry. This role will provide strategic direction and oversee the vendor qualification and compliance oversight program across GxP areas ensuring effectiveness of risk management strategies across third parties and internal vendor management. This role will also provide strategic direction and oversee advancement of the inspection readiness framework with responsibility for strategic management and hosting of regulatory inspections, as well as, oversight of effective and sustained quality risk mitigation and continual improvement strategies.Key Duties and Responsibilities:

  • Directs and leads the design, execution and continual improvement of proactive compliance oversight strategies and programs for independent oversight of operational execution, effectiveness of quality systems and standards, and adherence to internal and external regulatory requirements and expectations
  • Oversees the overall performance and effectiveness of the Internal Audit program in assuring regulatory compliance, quality risk management/mitigation, and adequacy and adherence to controls for quality and compliance with global GxP regulatory requirements, guidance, etc.
  • Establishes the product lifecycle management oversight program ensuring GxP compliance/quality oversight across a product/program portfolio
  • Manages and mentors Quality professionals for a diverse portfolio of products, technologies, and geographic span (small molecule, diagnostics, continuous manufacturing, cells, vectors, combination devices, global/regional/country)
  • Oversees the GxP risk assessment profile across the Quality Management System with the objective of ensuring transparency for gaining insights regarding state of compliance and adherence with quality standards/requirements across operational and Quality areas providing strategic input to improvement initiatives for advancing operational excellence in quality.
  • Partners with other Quality Management area heads to ensure alignment of strategic and operational goals with priorities of the business and QA for delivery of results necessary
  • Represents Vertex to various health authorities; gain acceptance and build trust externally as well as internally across various functions.
  • Anticipates the impact of the changing domestic and international regulatory environment, exiting legislation and guidelines on the development of plans, implementation strategies and post-marketing maintenance.
  • Provides leadership and management of monitoring of the external environment for leading practices, emerging trends and projection of future industry and QA capabilities requirements.
  • Partners with key stakeholders for alignment in strategic and operational planning and delivery of business priorities and goals.
  • Represents QA organization and serves as consultant, trusted advisor and partner to internal and external customers, partners, and stakeholders.
  • Apply risk management principles to decision making and operational priorities.
  • As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.Knowledge and Skills:
    • Contemporary understanding of global regulations and ICH guidance; direct Regulatory Authority experience or significant track record of interaction with health authorities across multiple regions.
    • QA experience in a Sponsor company or organization; or Contract Organization (CxO) with 10 years QA leadership experience spanning Quality operations (e.g., audit, compliance, inspection, operational quality management).
    • Highly collaborative and skilled at establishing effective working relationships with cross-functional groups and reaching common understanding on quality issues.
    • Comfortable working in a demanding fast-paced, patient-focused organization, with start-up culture and evolving processes. Flexible and able to adapt to new situations as the business demands.
    • Excellent verbal, written and presentation communication skills are essential.
    • Experienced in pre-clinical, clinical, and chemical, manufacturing and controls (CMC) processes with demonstrated knowledge and application of quality and risk management approaches across GxP areas.
    • A "doer" and individual willing to "roll up their sleeves" is key; flexibility to adapt to a start-up environment is required.
    • Operational Excellence experience with proven ability to lead improvement projects-Experience with Root Cause
    • Analysis and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.
    • Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions.
    • Ability to travel up to 15%.Education and Experience:
      • Bachelor's degree in a scientific or allied health field (or equivalent degree)
      • Typically requires 12 years of experience in addition to 5 years of management experience or the equivalent combination of education and experienceCompany InformationVertex is a global biotechnology company that invests in scientific innovation.Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.

Keywords: Vertex Pharmaceuticals, Boston , Senior Director, Quality Compliance, Executive , Boston, Massachusetts

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