Senior GMP Quality & Compliance Manager (Biologics/Devices)

BioPharma Consulting JAD Group

Boston (MA)

On-site

USD 150,000 - 230,000

Full time

2 days ago

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Benefits offered by this job

1 year contract with possible extend

Administrative shift

Job summary

BioPharma Consulting JAD Group is seeking an experienced GMP Operational Quality Senior Manager to lead QA/GMP disposition of drug substances, products, and devices. You will coordinate cross-functional teams and collaborate with CMOs to resolve complex quality issues and ensure compliant solutions.

The role requires extensive knowledge of cGMPs in biologics and devices, with experience in investigations, CAPA, and risk management.

Qualifications

In-depth knowledge of cGMPs in biologics + devices pharma setting.
Experience managing complex projects with CMOs/partners.
Experience leading investigations, RCA, and CAPA.
Proven ability to manage quality risk and compliance programs.

Responsibilities

Coordinate or execute QA/GMP disposition activities across multiple projects.
Lead cross-functional teams to resolve complex quality issues and ensure compliant solutions.
Draft and enforce Quality Agreements with CMOs and suppliers as needed.
Support Change Control processes and assess deviations and CAPAs for adequacy.
Review master and executed batch records for DS/DP/FG disposition.
Contribute to risk assessments and communicate mitigation plans.