Associate Director, Shift Quality Operations; Onsite

Position: Associate Director, Shift Quality Operations (Onsite)
## Associate Director, Shift Quality Operations (Onsite)
Apply locations:
Boston, MAtime type:
Full time posted on:
Posted Todayjob requisition :
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…