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

Biopharma Careers

Boston (MA)

On-site

USD 154,000 - 231,000

Full time

10 days ago

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Job summary

Vertex is seeking an Associate Director - Shift Quality Operations to provide senior QA leadership for aseptic cell therapy manufacturing at the VMC site. You will ensure cGMP compliance across shifts and leverage MES/LIMS/eQMS tools for real-time quality oversight.

You will lead a quality team, manage deviations and CAPAs, and partner with Manufacturing, MSAT, Validation, and Supply Chain to enable safe, reliable production and continuous improvement, while staying inspection-ready.

Qualifications

8+ years in biotech/regulated pharmaceutical environment
5+ years supporting aseptic manufacturing or parenteral production
Prior people leadership or supervisory experience preferred
Experience with shop floor QA oversight in a commercial or late-stage clinical setting

Responsibilities

Provide shift-based QA oversight for aseptic manufacturing operations across formulation, filling, and inspection activities.
Ensure activities comply with cGMP, GDP, site procedures, and aseptic standards.
Lead or support deviation triage, investigation, and CAPA development.
Mentor and develop a team of shift quality professionals; ensure coverage and effective handoffs.
Maintain inspection readiness and support internal audits, regulatory inspections, and client audits.

Skills

cGMP regulations

Aseptic processing

Quality systems

Root Cause Analysis

Data analytics

Education

Bachelor's degree in Biology/Microbiology/Chemistry/Pharmaceutical Sciences/Engineering

Master's degree preferred

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.

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