Senior Manager, Manufacturing Quality & CAPA Operations

Biopharma Careers

Boston (MA)

On-site

USD 142,000 - 213,000

Full time

3 days ago

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Job summary

Vertex is seeking a Senior Manager, Manufacturing Technical Operations (MTO) to develop and execute the quality-record strategy for quality events supporting CGT manufacturing. You will oversee CAPAs, deviations, change controls, and investigations with end-to-end responsibility, partnering with Manufacturing and QA to ensure compliance and continuous improvement.

The role is on-site at the Boston site with 2nd shift/weekend availability to support manufacturing needs, and involves leading a

Qualifications

In-depth knowledge of current Good Manufacturing Practices (cGMP) in pharma/biopharma manufacturing.
Strong ability to lead cross-functional teams and complex projects.
Excellent analytical and problem-solving skills to identify trends and drive improvements.
Exceptional verbal and written communication to tailor messaging to audiences.
Proven leadership to influence and build relationships across functions.

Responsibilities

Lead and develop a high-performing quality-record execution team (CAPAs, deviations, change controls, investigations).
Provide strategic oversight for CAPA and change-control records.
Oversee cross-functional investigations to determine root cause and recommend corrective actions.
Promote best practices to advance quality-event center-of-excellence capabilities.
Ensure timely, compliant closure of quality records and readiness for inspections.