Associate Director, Shift Quality Operations (Onsite)

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. This role is responsible for ensuring ongoing compliance with cGMP, aseptic processing requirements, site quality systems, and regulatory expectations while enabling safe, reliable, and efficient manufacturing.

The position partners closely with Manufacturing, Quality Assurance, Quality Control, MSAT, Engineering, Validation, and Supply Chain to support batch execution, deviation management, investigations, line clearance, contamination control, and continuous improvement. The Associate Director also leads and develops a team of quality professionals providing real-time shop floor quality oversight.

This On-Site role is located at Vertex's VMC

Key Duties & Responsibilities

• Provide shift-based QA oversight for aseptic manufacturing operations, including formulation, filling, inspection, and supporting activities as applicable.
• 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.
• Support batch disposition readiness through review of manufacturing documentation, events, and quality observations.
• Demonstrated understanding of digital quality systems, data management, automation, and emerging AI technologies within regulated GxP environments.
• Responsible for using platforms such as MES, LIMS, eQMS, data visualization tools, and advanced analytics to perform Quality oversight.

• Oversee quality execution for critical aseptic operations, material flow and contamination control practices, line clearance, and cell therapy manufacturing including chain of custody and identity.
• Ensure adherence to Contamination Control Strategy (CCS) and aseptic behaviors on the manufacturing floor.
• Provide real-time decision-making support during quality events and atypical situations.

• Lead or support deviation triage, investigation, root cause analysis, impact assessments, and CAPA development.
• Ensure quality issues are documented, investigated, and closed in a timely and compliant manner.
• Identify recurring issues and drive sustainable improvements to prevent repeat events.
• Expertise in utilizing eQMS platforms for QMS activities.

• Lead, coach, and develop a team of shift quality professionals.
• 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.

• Maintain a constant state of inspection readiness for aseptic manufacturing areas.
• Support internal audits, regulatory inspections, and client audits.
• Ensure observations are addressed promptly and effectively.

• Partner with site leadership and cross-functional teams to support:
  • Production schedule adherence
  • Product quality
  • Operational excellence
  • Tech transfer/startup activities
  • Process improvements
  • Act as a trusted advisor on quality risk and compliance decisions.

Required Education Level

• Bachelor's degree in Biology, Microbiology, Chemistry, Pharmaceutical Sciences, Engineering, or related discipline required.
• Preferred master's degree or relevant comparable background.

Required Experience

• 8+ years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment.
• 5+ years of experience supporting aseptic manufacturing, sterile operations, or parenteral production.
• Prior people leadership or supervisory experience strongly preferred.
• Experience with shop floor QA oversight in a commercial or late-stage clinical manufacturing environment preferred.

Required Knowledge/Skills

• Strong knowledge of:
  • cGMP regulations
  • Aseptic processing principles
  • Annex 1, FDA sterile manufacturing expectations, and contamination control concepts
  • Deviation/CAPA/investigation systems
  • Batch record review
  • Risk management and quality systems
• 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.
• Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.
• Critical Thinking and Problem Solving skills

Other Requirements

Up to 5% travel

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Onsite

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