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Associate Director, GCP QA Inspection Readiness Hybrid

Semma Therapeutics

Semma Therapeutics

Quality Assurance
Boston, MA, USA
Posted on Wednesday, July 10, 2024

Job Description

General Summary:

This individual will have overall responsibility for lifecycle review of risks to quality through ensuring appropriate oversight, mitigation strategies and plans enabling clinical quality outcomes and real time inspection readiness.

This individual will partner closely with the Therapeutic Area leads and program leadership in the design and execution of program quality strategies and provide transparent insights into program risks and issues to will deliver proactive and sustainable clinical quality and compliance.

This individual will utilize their regulatory intelligence and technical expertise to optimize interdisciplinary understanding, synergy to integrate activities across GCP QA and functional stakeholders to optimize inspection readiness and preparedness objectives.

This individual is responsible to support the PQL/SQL in the development and oversight of internal and external inspection readiness management, as well as supporting inspections within GCP QA organization.

Key Duties and Responsibilities:

  • Manage Program GCP QA inspection readiness plans (in real time) in conjunction with PQLs, communicate/escalate inspection risks to Senior Leadership and functional stakeholders.
  • Develop strategy and lead efforts to shift from heavy reliance on readiness plans to operating in an inspection ready state.
  • Provide input into inspection risks, supporting the identification of inspection and quality risks and appropriate mitigation plans to achieve compliant solutions/optimize inspection outcomes.
  • Assist with guiding teams (in conjunction with PQL) to develop oversight of mitigation plans and ensure visibility of mitigation plans are established for any critical observation detected.
  • Mentors Clinical Quality QA teams as well as business operations to optimize inspection readiness and preparedness.
  • Monitor and interpret GCP regulatory guidelines and trends and incorporate into phase appropriate compliance strategies.
  • Supports global regulatory inspection activities at Vertex hosted inspections or Clinical Investigator Sites, as required.
  • Identifies, consults and escalates on quality issues as associated with clinical trials providing appropriate recommendations/solutions for immediate and long-term resolution.
  • Provide leadership and direction for ongoing projects, to cross-functional teams, and at management review meetings on GCP related activities/issues.
  • Assist in the evaluation of the health of the Quality Systems and associated KPIs and supports development of mitigation plans as necessary.

Knowledge and Skills:

  • Expert knowledge and awareness of ICH GCP E6 R2 and applicable global regulations and guidance for clinical development (e.g., FDA, EMA, MHRA, etc.)
  • Extensive and demonstrated experience with all phases of clinical trial development involving drugs, biologics, devices, and drug/ device combinations.
  • Considerable technical depth in Event Management processes and requirements, including investigation, root cause analysis, CAPA plan development and Effectiveness Checks.
  • Ability to understand and translate customer needs and develop innovative and creative approaches to quality management, requiring sophisticated analytical and interpretive thinking.
  • Adept at communicating professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers.
  • Ability to work independently with minimal guidance, organizing and prioritizing work effectively for timeliness, accuracy and quality.
  • Significant depth of specialized scientific knowledge to manage quality oversight for highly complex clinical trials; understands medical terminology, standards of care and disease states to assure the ethical treatment of subjects.
  • Significant background in risk management principles and tools to manage risks and risk mitigation efforts.
  • Strong leadership skills with demonstrated success in mentoring and developing team members.
  • Ability to communicate effectively across all organizational levels.
  • Excellent analytical, critical thinking, and soft skills to build collaborative relationships enabling effective and harmonious interactions with internal and external stakeholders.
  • Advance knowledge with quality metrics, dashboards, analysis and improvement programs.
  • In depth knowledge of ICH E6, 21 CFR Part 312 and/or 21 CFR Part 58
  • Basic knowledge of 21 CFR Parts 56 and 314 preferred.

Education and Experience:

  • A Bachelor’s degree in a scientific or allied health field (or equivalent degree).
  • Typically requires 8-10 years of experience or the required combination of education and experience in pharmaceutical, medical device or biologics company.

#LI-Hybrid

#LI-AR1

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

Company Information

Vertex 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.

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