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Director, Quality Compliance, Cell & Gene (Hybrid)

Semma Therapeutics

Semma Therapeutics

Legal, Quality Assurance
Boston, MA, USA
Posted on Thursday, February 1, 2024

Job Description

General Summary:

The Quality Compliance Director provides strategic leadership for quality culture, inspection readiness, clinical to commercial transition, and escalation process for the cell and gene therapy business unit. The role has specific focus on external and internal manufacturing/testing inspection readiness and ongoing compliance to changing regulatory expectations. This position focuses not just on the “what” but the “how”, ensuring phase appropriate quality compliance.

***This is a hybrid role working 3 days on-site and up to 2 days remotely.**

Key Duties and Responsibilities:

  • Provides tactics to address compliance gaps or determines enhancements to improve the overall quality culture of the programs
  • Leads inspection and compliance programs both internally and externally. Works cross-functionally across many different functional areas and programs.
  • Provide leadership, strategic thinking, and mentorship to staff, focusing on employee development and leadership skills
  • Leads and manages complex projects/teams within corporate objectives and project timelines
  • Monitor and interpret cGMP regulatory guidelines and trends in the breakthrough therapy regulatory space and incorporate into inspection readiness and control strategies
  • Collaborate with internally and external business partners to resolve complex quality issues to ensure compliant solutions
  • Be directly involved in and where appropriate, lead multiple process/product improvement projects which may include quality system process improvements, development of new methodologies and improving existing methodologies, data generation, report development and presentation
  • As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.

Knowledge and Skills:

  • Expert knowledge of global GMP requirements governing CGT products

    • Superb facilitation, Communication, and Coaching/influencing skills with proven ability to lead teams

    • Ability to evaluate quality matters and make decisions utilizing risk-based approach

    • Solid quality culture knowledge and understanding of how to influence and improve overall compliance

    • Strong presentation skills and ability to influence others

    • Proven ability to identify and analyze performance indicators.

Education and Experience:

  • Bachelor's degree in a scientific discipline, operations research, operations management, or a related field
  • Typically requires 10 years of relevant experience and 2 years of supervisor/management experience, or the equivalent combination of education and experience

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid, or On-Site-Eligible role, you can choose to work:

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.

#LI-AR1 #LI-Hybrid

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