GMP Operational Quality Senior Manager

Job overview

The GMP Operational Quality Senior Manager role is onsite in Boston, MA. Compensation is not specified. The role supports quality assurance and compliance activities, including GMP disposition of drug products and devices. This senior technical resource coordinates complex quality work and helps ensure compliant product disposition and quality systems. The role investigates deviations, assesses risks and product impact, reviews batch records and controlled documents, and supports audits and corrective actions.

What you'll do

• Collaborate with business partners to resolve quality issues
• participate in cross-functional teams
• draft and enforce quality agreements
• initiate and assess change controls
• conduct investigations and review corrective action plans
• identify and approve CAPAs
• review batch records for disposition
• review GMP documents
• communicate risks and mitigation plans
• support internal and external audits.

What we're looking for

Skills & competencies

gmp quality

boston ma

senior manager

quality assurance

gmp compliance

biologics

medical devices

capa

change control

batch records

quality investigations

audit support

Work arrangement

• Weekend coverage required

Benefits & perks

• One-year contract with possible extension
• administrative shift.

Why this role

Emphasis on GMP disposition of drug products and devices, biologics, and contract manufacturing organizations.

About the employer

BioPharma Consulting JAD Group is hiring for this role. Industry: Human Resources Consulting Services. Sector: 54.