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Associate Director, Vendor Management, Quality Assurance
at Vertex
Boston, MA

Associate Director, Vendor Management, Quality Assurance
at Vertex
Boston, MA

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Description

Job Description:

Vertex Pharmaceuticals is looking for a GMP/GDP/GVP QA Associate Director to join our Quality Assurance team reporting to the Director, QA Vendor Oversight. The QA Vendor Management team is responsible for proactively supporting vendor compliance and quality for vendors participating in GxP regulated environments using a risk-based model.

This position is responsible for managing quality oversight, issue management and opportunities for improvement and developing relationships with a variety of GMP, GDP, and GVP vendors used by Vertex. Experience with key performance indicators, vendor oversight and quality metrics is advantageous.

KEY RESPONSIBILITIES:
  • Will have responsibility for Vendor Management of early phase development to commercial Quality function to ensure appropriate and timely vendor qualification and maintenance
  • Maintains and manages risk-based model for management and quality oversight of GMP, GDP and GVP vendors
  • Manage improvements and contribute to the advancement of the GMP, GDP and GVP QA Vendor Management program by identifying opportunities and implementing risk-appropriate enhancements to the Vendor Oversight infrastructure.
  • Oversee quality and compliance monitoring across GMP, GDP and GVP vendors using vendor oversight strategies, that include but are not limited to:
    • Serving as GMP, GDP and GVP QA interface to vendor QA partners in support of quality management, inspection readiness and continuous improvement
    • Partnering with business stakeholders for ensuring adequate governance and quality oversight across vendors, including representing Vertex GMP, GDP and GVP QA in Joint Operating Committees for selected vendors
    • Guiding Vertex QA teams and business functions/teams to assess risk management strategies, vendor selection /remediation, and quality metrics monitoring (Vendor Performance Dashboards /Quality Scorecards)
  • Ensure adequacy of and compliance to Quality Agreements, in part through ensuring development and evolution of integrated quality scorecards across GMP, GDP and GVP vendors
    • Monitoring 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) across GMP, GDP, GVP vendors
    • Maintain and evolve the Vendor Change Notification Process
    • Maintain and evolve the Vendor definitions and Approved Vendor List
  • Partner with QA Audit team to input and influence audit of vendors across GMP, GDP, GVP
    • Manage/Conduct vendor audit as applicable
      • Onsite participation
      • Directed/For-Cause audit participation
  • Partner with Functional QA teams for sharing and aligning on risks, issue management, CAPA, improvements and quality outcomes, including inspection readiness
  • Provides Quality oversight and 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
  • Lead and/or participate in GMP, GDP and GVP QA teams process improvement projects both within GMP, GDP and GVP QA as well as more broadly
#LI-RS1

Qualification:

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

Additional Minimum Qualifications:
  • Demonstrated working knowledge and application of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and/or Good Pharmacovigilance Practice (GVP) , 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
    • Familiarity with the principles of 21 CFR Part 11
    • Basic knowledge of 21 CFR Parts 56 , Advanced Therapy Medicinal Products (ATMP) preferred, but not required
  • 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, requirements, language, roles and skillset to conduct audit
    • Inspection Management and Preparation
  • Strong communication, influence and facilitation skills
  • Project Management, Planning and Prioritization skills
  • Technical writing skills
  • Adaptability / flexibility
  • Strategic "big picture" thinking while maintaining ability to execute at a tactical level / attention to detail
  • Adheres to the QA department goals and ensures linkage to individual goals

PREFERRED QUALIFICATIONS:

Experience with the following:
  • Vendor Management or vendor QA experience would be a differentiator
  • Use of electronic audit management systems
  • Quality metrics, dashboards, analysis and improvement programs

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