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Senior Director Quality GLP, Research, and Biomarkers (Hybrid)

Semma Therapeutics

Semma Therapeutics

Sales & Business Development, Quality Assurance
Boston, MA, USA
Posted on Tuesday, February 13, 2024

Job Description

General Summary:

The Senior Director, Quality GLP, Biomarkers and Research has overall accountability for strategic leadership and oversight of the end-to-end quality assurance strategy for proactive, risk-informed, and sustainable quality oversight and compliance with regulatory expectations across Vertex processes for clinical evidence generation and product vigilance

Key Duties and Responsibilities:
• Serves as a strategic partner to functional leaders across product modalities responsible for Research (including both non-regulated and GLP work), Biomarker Development, and Diagnostics in assuring appropriate quality/compliance oversight of processes and systems supporting effective delivery of these programs and the rigor and integrity of associated data.
• Defines strategy for and oversees tactical execution strategic plan by direct reports to provide effective oversight of research, assay development in support of pre-clinical and clinical research, GLP animal studies, in vitro diagnostic development, and all R&D vendors. Assures operational quality activities are informed by risk and assure the integrity of data submitted to regulatory authorities and in external forums.
• Responsible for assuring that key research & pre-clinical studies (internal and external) are performed in accordance with good scientific practices, good laboratory practices, Vertex policies and procedures and relevant local, regional, and international requirements.
• Leads an operational quality team responsible for identifying and anticipating potential compliance issues that may impact the ability to meet business goals, developing and implementing methods of improvement and resolution in a pragmatic and effective manner
• Oversees effective, timely, and appropriate identification, remediation, and escalation of quality issues in key Research, GLP, Biomarker, IVD and vendor governance-related activities across Vertex.
• Provides periodic updates on the overall health of Research, GLP, Biomarker, and IVD development-related processes and systems to functional leaders across Research, Biomarker Development, and Diagnostics.
• Oversees and assures timely and effective communication of summary trending and other insights on the quality of delivery in research, preclinical, biomarker, IVD work, and vendor performance to relevant business and quality leaders and in relevant forums.
• Oversees Inspection Readiness activities in collaboration with business and Quality Assurance partners related to research, GLP, biomarkers, IVD development activities.
• Chairs relevant operational governance meetings (e.g. QLT)
• Serves as the R&D Quality lead and oversees and guides staff participating in strategic cross-functional initiatives (e.g. Research Ethics, TRPM to improve quality, data integrity, and compliance to regulatory requirements and standards, ensuring a aligned Quality point-of-view is represented.
• Maintains an in-depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to Research, GLP, Biomarker, and IVD activities.
• Drives and oversees implementation of new and evolving regulatory requirements related to areas of responsibility.
• Leads and/or participates in industry forums and external initiatives related to areas of responsibility to influence policy development related to oversight of these activities, as aligned with functional leadership and Vertex interests.
• Provides strategic direction, oversight, coaching and mentoring to direct reports.

Education and Experience:

  • M.S. (or equivalent degree) and 10 +years of relevant work experience, or
  • B.S. in a scientific or allied health field (or equivalent degree) and 15+ years of relevant work experience, or relevant comparable background

Hybrid-Eligible Roles

In this Hybrid-Eligible role, you can choose to be designated as:

Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility.

#LI-Hybrid #LI-AR1

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.