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Description

The Manufacturing Technical Operations (MTO) team, responsible for driving the most complex, cross‑functional, and high‑visibility quality investigations supporting cell therapy manufacturing at the Boston site. This role is heavily focused on investigations, including Deviations, CAPAs, Change Controls, and Analytical/Quality Control investigations within the electronic Quality Management System (eQMS). The Expert Lead ensures rigorous triage, advanced root cause analysis, SME alignment, and timely, compliant closure of records in a fast‑paced, highly regulated environment.

Key Responsibilities

• Lead high‑complexity deviation investigations, including triage, data mining, GEMBA walks, and coordination with multidisciplinary SMEs.
• Drive advanced root cause analysis using structured methodologies (5‑Why, Ishikawa, KT, GEMBA) to identify systemic issues and prevent recurrence.
• Own and execute complex CAPAs, ensuring robust effectiveness checks, cross‑functional alignment, and sustainable long‑term solutions.
• Initiate and guide Change Control records, ensuring accurate impact assessments, risk evaluations, and implementation strategies.
• Lead Analytical and QC investigations, including method performance review, data trending, and identification of quality risks.
• Ensure all quality records meet internal, regulatory, and industry standards for completeness, accuracy, and timeliness.
• Serve as a senior technical authority during internal audits, external inspections, and regulatory interactions.
• Partner with Manufacturing, QC, QA, MS&T, Engineering, and Supply Chain to resolve complex issues and strengthen process robustness.
• Identify patterns and recurring deviations, leading cross‑functional initiatives to reduce variability and improve manufacturing reliability.
• Mentor junior and mid‑level investigators, providing coaching on investigation strategy, documentation quality, and compliance expectations.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Biotechnology, Project Management, or related field.

• 10+ years of experience in pharmaceutical, biotechnology, cell therapy, or regulated manufacturing environment.
• Proven ability to independently lead high‑complexity investigations and CAPAs in a fast‑paced environment.
• Deep understanding of cGMP, FDA/EMA regulations, and quality systems.
• Extensive experience with electronic Quality Management Systems (eQMS).
• Exceptional analytical, problem‑solving, and technical writing skills.
• Strong leadership presence with the ability to influence and guide cross‑functional teams.
• Demonstrated ability to manage multiple high‑visibility records simultaneously while meeting aggressive timelines.

Preferred Skills

• Experience in cell therapy, biologics, aseptic processing, or advanced therapy manufacturing.
• Proficiency with MES, LIMS, TrackWise, or similar systems.
• Formal training in advanced RCA methodologies (Kepner‑Tregoe, Ishikawa, 5‑Why).
• Experience mentoring and developing investigation talent.

Benefits

• 12-month contract with possible extension
• Administrative shift
• Overtime availability