Associate Director, Shift Quality Operations (Cell and Genetic Therapies)

Regulatory Jobs; Boston (MA); On-site; USD 154,000 - 231,000; Full time

Job summary

Vertex is seeking an Associate Director for Shift Quality Operations on-site at its Vertex Manufacturing Campus (VMC). You will provide real-time quality leadership across shifts for cell therapy manufacturing, ensuring compliance with cGMP and aseptic processing while coordinating with Manufacturing, QA, QC, MSAT, Engineering, Validation, and Supply Chain.

You will lead a team of quality professionals, drive deviation investigations, TRIAGE, CAPA processes, and maintain inspection readiness on

Qualifications

• 8+ years in biotech/regulated pharma manufacturing quality roles
• 5+ years supporting aseptic manufacturing or parenteral production
• Experience leading shift QA oversight on shop floor
• Strong knowledge of cGMP, aseptic processing, and contamination control
• Experience with deviation/CAPA/investigation systems and QA data analytics
• Ability to drive continuous improvement and lead teams on quality readiness

Responsibilities

• Provide shift-based QA oversight for aseptic manufacturing operations
• Ensure compliance with cGMP, GDP, procedures and aseptic standards
• Lead or support deviation triage, investigations, and CAPA development
• Manage and develop a team of shift quality professionals
• Maintain inspection readiness and support regulatory inspections
• Collaborate cross-functionally to support product quality and operational excellence

Skills

QA Leadership

GxP Compliance

Aseptic Processing

cGMP

Data Analytics

Root Cause Analysis

Education

Bachelor’s degree in Biology/Pharmaceutical Sciences/Engineering

Master’s degree preferred

Tools

MES

LIMS

eQMS

Job description

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

Quality Oversight

• 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.

Aseptic Operations Support

• 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.

Deviation, Investigation, and CAPA Management

• 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.

Team Leadership

• 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.

Inspection Readiness and Compliance

• 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.

Cross-Functional Collaboration

• 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

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Pay Range

$153,900 - $230,900

Disclosure Statement

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.

Flex Designation

On-Site Designated

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.

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 [e-mail]