Job Description
General/Position Summary
The Associate Director – Shift Quality Operationsis 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
Pay Range:
$153,900 - $230,900
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
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.
#LI-Onsite
