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Associate Director, GMP/GDP Vendor Management

Semma Therapeutics

Semma Therapeutics

Boston, MA, USA
Posted on Saturday, December 16, 2023

Job Description

General Summary:

The Associate Director, Vendor Quality Management is responsible for proactively and comprehensively monitoring vendor quality and compliance risk for small molecule GMP/GDP vendors. This position is responsible for developing, maintaining, and disseminating vendor data and analytics, including but not limited to vendor key performance indicators, vendor quality metrics, and a vendor risk scorecard, to QA and to key business partners at the enterprise and program levels. The role also drives continuous improvement in Vertex vendor quality processes and governance to assure Vertex remains adherent to regulatory expectations and supports QA operational quality oversight and management of complex vendor issues within the GMP/GDP small molecule space.

Key Duties and Responsibilities:

  • Responsible for Vendor Management of early phase development to commercial to ensure appropriate and timely vendor qualification and maintenance
  • Maintains and manages risk-based model for management and quality oversight of GMP and GDP vendors
  • Manage improvements and contribute to the advancement of the GMP and GDP Vendor Management program by identifying opportunities and implementing risk-appropriate enhancements to the Vendor Oversight infrastructure.
  • Oversee quality and compliance monitoring across GMP/GDP vendors using vendor oversight strategies, that include but are not limited to:
    • Serve as GMP/GDP interface to vendor QA partners in support of quality management, inspection readiness and continuous improvement;
    • Partner with business stakeholders for ensuring adequate governance and quality oversight across vendors, including representing Vertex GMP/GDP in Quality to Quality meetings and/or Joint Operating Committees for selected vendors;
    • Develop/mature Vendor Performance Dashboards /Quality Scorecards
      • Guide Vertex QA teams and stakeholders to assess risk management strategies, vendor selection /remediation, and quality metrics monitoring
  • Ensure adequacy of and compliance to Quality Agreements, in part through ensuring development and evolution of integrated quality scorecards across GMP/GDP vendors.
  • Monitor metrics and dashboards for emerging trends across vendors
  • Support Functional Area QA and QA Audit Team to resolve observations and quality issues arising across vendors, including but not limited to:
    • Risk/impact assessment, specifically with respect to impact across vendors;
    • CAPA development, execution, effectiveness assessment;
    • Coordination and facilitation of cross functional teams internal to Vertex and with vendors as appropriate for management and application of CAPA to correct and prevent quality issues/observations, trends and risks.
  • Maintain and evolve models and mechanisms for ensuring awareness and application of QMS requirements (e.g. qualification, quality agreements, vendor change notification process) across GMP/GDP vendors.
  • Partner with QA Audit and Inspection Management team and provide input to audits and qualification of GMP/GDP vendors
  • Provides Quality consultation/direction to internal Technical Operations, Pharmaceutical Science Operations organization and external support for all Vertex Contract Manufacturing Organizations (CMOs) that manufacture and test Commercial Products.
  • Serve as SME and participate in inspection preparation and management activities for selected vendors as appropriate.
  • Support vendor segmentation of GMP/GDP vendors
  • Lead and/or participate in process improvement projects to evolve quality systems/processes

Knowledge and Skills:

  • Demonstrated working knowledge and application of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) including US and international/global regulatory requirements and associated guidances and standards.
  • In depth knowledge of ICH Q7, ICH Q8, ICH Q9 , ICH Q10, 21 CFR Part 210, 21 CFR Part 211, 21 CFR Part 620, and/or 21 CFR Part 820.
  • Strong working knowledge of:
    • Risk Management
    • Event/Quality Issue Management process and requirements, including CAPA and Effectiveness Checks;
    • Root Cause Analysis and Investigation process tools and techniques;
    • Auditing process
    • Inspection Readiness
  • Strong oral and written communication and interpersonal skills
  • Project Management, Planning and Prioritization skills
  • Technical writing skills
  • Adaptability / flexibility and ability to work in a fast-paced environment and act with urgency
  • Strategic “big picture” thinking while maintaining ability to execute at a tactical level / attention to detail.
  • Strong analytical thinking skills, with the ability to translate data into risk-informed insights that drive decision-making.

  • Experience advising, coaching or mentoring junior staff

Education and Experience:

  • Master’s degree and 5-8 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 10+ years of relevant work experience, or relevant comparable background.

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:

1. On-Site and work 5 days per week with ad hoc flexibility;

2. Hybrid and work remotely up to two days per week on regularly scheduled days; or select

#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