Vertex Pharmaceuticals

Vertex Pharmaceuticals

Associate Director, Shift Quality Operations

Boston, MA · Director

Sponsorship not specified$154k-$231kDetected 11 hours ago
Data AnalysisData VisualizationSupply ChainRecruitingGMPFDA RegulatoryLeadershipCommunicationCollaborationProblem SolvingCritical ThinkingGxP

About the role

  • Job Description General/Position Summary The Associate Director - Shift Quality Operations is an advanced technical resource in the principles and application of quality assurance and compliance.
  • The Associate Director provides quality leadership and oversight for manufacturing operations conducted across assigned shifts for cell therapy manufacturing.
  • Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

Requirements

  • Required Knowledge/Skills
  • Strong knowledge of:
  • Ability to assess quality risk in real time and make sound compliance-based decisions.
  • Ability to lead improvement projects. experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.

Nice to have

  • Production schedule adherence
  • Operational excellence
  • Tech transfer/startup activities
  • Process improvements
  • Act as a trusted advisor on quality risk and compliance decisions.
  • Bachelor's degree in Biology, Microbiology, Chemistry, Pharmaceutical Sciences, Engineering, or related discipline required.
  • Preferred master's degree or relevant comparable background.
  • 8 + years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment.

Skills

  • Ensure manufacturing activities are executed in compliance with cGMP, GDP, site procedures, and aseptic processing standards.
  • Serve as the primary quality representative for escalating critical quality issues appropriately.
  • Ensure adherence to Contamination Control Strategy (CCS) and aseptic behaviors on the manufacturing floor.
  • Ensure quality issues are documented, investigated, and closed in a timely and compliant manner.
  • Expertise in utilizing eQMS platforms for QMS activities.
  • Establish clear goals, performance expectations, and development plans.
  • Promote a culture of quality, accountability, inspection readiness, and continuous improvement.
  • Ensure adequate shift coverage and effective handoff across shifts.
  • Support internal audits, regulatory inspections, and client audits.
  • Ensure observations are addressed promptly and effectively.

Compensation

  • $153,900 - $230,900
  • 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.