Associate Director, Shift Quality Operations

Vertex Pharmaceuticals; Boston (MA); On-site; USD 153,900 - 230,900; Full time

Job summary

Vertex Pharmaceuticals seeks an Associate Director, Shift Quality Operations to lead real-time QA on aseptic cell therapy manufacturing on-site in Boston. You will oversee deviations, investigations and CAPAs, ensuring inspection readiness and regulatory compliance across shifts while partnering with Manufacturing, QA and MSAT teams.

The role requires strong leadership, deep cGMP knowledge, and experience with quality systems and data analytics to drive continuous improvement on the shop floor.

Qualifications

• Bachelor's degree in biology, microbiology, chemistry, pharmaceutical sciences, engineering or related field is required.
• Master's degree or relevant comparable background preferred.
• 8+ years of relevant industry experience in biotech/pharma manufacturing or quality.
• 5+ years supporting aseptic manufacturing, sterile operations or parenteral production.
• Prior people leadership or supervisory experience is preferred.
• Experience with shop floor QA oversight in commercial or late-stage clinical manufacturing.

Responsibilities

• Provide shift-based QA oversight for aseptic manufacturing operations including formulation, filling and inspection.
• Ensure activities comply with cGMP, GDP, site procedures and aseptic standards.
• Serve as primary quality representative for escalating critical quality issues.
• Support batch disposition readiness through review of documents and observations.
• Utilize MES, LIMS, eQMS and analytics for quality oversight and improvement.
• Lead deviation triage, investigations, CAPA development and close-out.

Skills

cGMP regulations

Aseptic processing

Deviation management

CAPA investigation

Data analytics

Lean Six Sigma

Quality risk management

Team leadership

Communication

Education

Bachelor's degree in Biology, Microbiology, Chemistry, Pharmaceutical Sciences, Engineering, or related discipline

Master's degree preferred

Tools

MES

LIMS

eQMS

Data visualization tools

Job description

## Associate Director, Shift Quality Operations (Onsite)Applylocations: Boston, MAtime type: Full timeposted on: Posted Todayjob requisition id: REQ-29572**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**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.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.