QA Manager, cGMP Biopharma & Compliance

CAMRIS International, LLC; Silver Spring (MD); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with employer matching

Tuition and professional reimbursement

Paid time off and holidays

Job summary

CAMRIS International, LLC seeks a Quality Assurance Manager for the Walter Reed Army Institute of Research Pilot Bioproduction Facility in Silver Spring, MD. Lead QA activities, oversee cGMP compliance, and drive audit readiness and document control.

You will manage the QA team, implement risk-based compliance, coordinate with clients and external stakeholders, and contribute to continuous improvement including training programs and SOP approvals.

Qualifications

• BS/BA in biology or related field with 12 years of biotech/pharma experience.
• Experience in phase 1 manufacturing (vaccine production, mRNA, monoclonal antibodies).
• QA management/supervision with documentation control, raw material management, instrument calibration, validation, audit competency, and training expertise.

Responsibilities

• Manages QA at WRAIR PBF overseeing cGMP compliance, release, policies, and training.
• Guides PBF in advancement of compliance initiatives for expansion of capabilities (multiplatform manufacturing, mAb and mRNA GMP).
• Interfaces with PBF clients, WRAIR Quality and QA counterparts representing both PBF and CAMRIS.
• Leads audit preparation, responses, and tracks outstanding compliance initiatives.
• Oversees QA responsibilities including inventory of in-process/final products, raw materials, staff training, document control, and validation/maintenance.
• Implements cGMP systems: training, deviations, investigations, change controls, CAPAs, audits.
• Establishes and implements risk-based compliance approaches.
• Reviews/approves IOQ documents, batch records, and SOPs.
• Dispositions drug substance/product produced at PBF for clinical testing (final signatory).
• Prepares briefs on QA matters including Quarterly Management Review.
• Supervises the site quality team.
• Provides technical assistance to CAMRIS HQ and participates in proposals when requested.
• Maintains a safe workplace and adheres to safety procedures.

Skills

QA management

Audits

Documentation control

Regulatory compliance

Vendor oversight

Education

BS/BA in biology or related field

Job description

CAMRIS International, LLC seeks a Quality Assurance Manager for the Walter Reed Army Institute of Research Pilot Bioproduction Facility in Silver Spring, MD. Lead QA activities, oversee cGMP compliance, and drive audit readiness and document control.

You will manage the QA team, implement risk-based compliance, coordinate with clients and external stakeholders, and contribute to continuous improvement including training programs and SOP approvals.