Vertex Pharmaceuticals

Vertex Pharmaceuticals

Associate Director, GMP Operational Quality

Boston, MA · Director

Sponsorship not specified$95k-$142kDetected 4 days ago
ComplianceNegotiationRecruitingGMPFDA RegulatoryLeadershipCommunicationCollaborationRegulatory Affairs

About the role

  • Job Description General Summary: The Associate Director, GMP Operational Quality Assurance is a Quality leader and advanced technical resource responsible for strategic and operational Quality oversight across multiple complex programs.
  • The role provides Quality oversight for drug substance disposition from development through process performance qualification, ensuring decisions align with patient safety, product quality, regulatory expectations, and business continuity.
  • Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

Responsibilities

  • Lead cross-functional collaboration with Manufacturing, Quality Control, MSAT, Regulatory Affairs, and other Quality functions to resolve complex deviations and align decisions with patient safety, product quality, and regulatory compliance
  • Lead drafting, negotiation, and oversight of Quality Agreements with CDMOs, suppliers, and Vertex, as needed
  • Review and approve master and executed batch records to support external drug substance disposition activities
  • Analyze Quality Metrics and performance trends to identify risks, drive continuous improvement, and inform Quality leadership decisions
  • Develop and recommend strategies to address compliance gaps and strengthen cross-functional quality systems
  • Lead or contribute to operational review and escalation meetings to ensure Quality issues are appropriately prioritized, assessed, escalated, and resolved for external drug substance manufacturing operations
  • Drive completion of assigned QLT action items by coordinating stakeholders, clarifying expectations, and ensuring timely follow-through
  • Provide technical Quality guidance during partner and regulatory agency audits
  • Drive Quality readiness for major development milestones including IND/IMPD submissions, clinical supply manufacturing, PPQ, and regulatory inspections

Skills

  • Demonstrated ability to operate independently, exercise sound judgment, and provide quality leadership for large, multifaceted projects
  • Experience leading complex event investigations, root cause analysis, CAPA strategy, and effectiveness assessments
  • Education and Experience:
  • Bachelor's degree in a scientific or allied health field (or equivalent degree)

Compensation

  • $94,600 - $141,800
  • The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting.
  • This role is eligible for an annual bonus and annual equity awards.
  • Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.
  • Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

Benefits

  • This role is eligible for an annual bonus and annual equity awards.

Company info

  • 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
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This listing is sourced directly from Vertex Pharmaceuticals's careers page and normalized into a canonical job model.