Job Description

Job Title: Senior Manager – Manufacturing Quality Assurance

Location: North Carolina

Job Type: Full-Time

Work schedule: Normal business hours Monday-Friday 9 -5

Salary: $150,000 Yearly

Overview:
We are seeking a Senior Manager – Manufacturing Quality Assurance to lead quality operations in a fast-paced pharmaceutical manufacturing environment. The ideal candidate will have a proven track record in cGMP compliance, regulatory inspection readiness, and managing enterprise-level quality systems for sterile or parenteral production.

Key Responsibilities:

• Oversee QA operations, including batch record review, SOP management, deviation/CAPA investigations, and change control.
• Manage validation activities for processes, equipment, utilities, and computerized systems.
• Lead inspection readiness efforts and represent QA during FDA/DEA audits.
• Drive continuous improvement initiatives to enhance documentation accuracy and process efficiency.
• Recruit, train, and mentor QA staff while managing budgets and resources.

Qualifications:

• Bachelor’s degree in a scientific field (advanced degree preferred).
• 15+ years in manufacturing quality assurance with at least 5 years in leadership roles.
• Strong knowledge of cGMP, GLP, FDA/DEA regulations, and ISO standards.
• Experience in CAPA, change control, risk management, and tech transfer.
• Exceptional communication, problem-solving, and leadership skills.

Preferred:

• Experience with sterile manufacturing and aseptic operations.
• Prior front-/back-room leadership during inspections.
• Familiarity with ALCOA+ and quality metrics.

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