Quality Assurance Manager / Sr. Manager - Deviations and CAPAs (Biopharma)

Location: Fully site-based in Durham, North Carolina, USA; not remote.

Company

Biopharmaceutical manufacturing organization focused on biotechnology-derived products and regulated quality systems.

What you will do

• Lead, mentor, and develop QA Specialists and investigators while balancing workloads to support manufacturing and batch release timelines.
• Manage site QA oversight of deviation triage, investigation review and approval, and the CAPA program.
• Review and approve manufacturing, facilities, engineering, and excursion deviations and CAPAs in collaboration with functional teams.
• Coordinate client communications, address comments with internal subject-matter experts, and represent Quality in client meetings.
• Report quality-system metrics, improve site processes, and support manufacturing operations, client audits, and regulatory inspections.
• Collaborate with Global QA Compliance and other sites on SOPs, training materials, process alignment, and trainer development.

Requirements

• Bachelor’s degree in pharmaceutical science, biology, chemistry, or a related scientific discipline.
• At least 5 years of leadership experience in pharmaceutical, biological, or quality assurance environments.
• Thorough knowledge of GMP guidelines as they apply to quality systems and compliance.
• Knowledge of worldwide regulatory requirements, particularly those for biotechnology-derived products.
• Experience managing data and metrics and presenting information to senior management.
• Strong interpersonal, teamwork, attention-to-detail, and problem-resolution skills.

Culture & Benefits

• Full-time, site-based work supporting manufacturing and batch release activities.
• Collaboration with global QA teams and cross-functional site groups.
• Opportunities to mentor QA personnel, investigators, and qualified trainers.
• Equal opportunity employer committed to workforce diversity.