Quality Assurance Manager (Pharmaceutical)

Quality Assurance Manager (Pharmaceutical)

Job Summary

We are seeking an experienced Quality Assurance Manager to oversee quality systems, regulatory compliance, and quality assurance activities within a pharmaceutical manufacturing environment. The ideal candidate will have strong knowledge of cGMP regulations, quality management systems, laboratory operations, and regulatory requirements.

Key Responsibilities

• Manage and maintain Quality Assurance systems to ensure compliance with cGMP and regulatory requirements.
• Develop, review, and implement Standard Operating Procedures (SOPs).
• Review and approve change controls, CAPAs, deviations, and investigations.
• Oversee quality and compliance activities within QC laboratories.
• Review analytical method validation protocols, reports, and specifications.
• Provide quality oversight of Contract Development and Manufacturing Organizations (CDMOs).
• Support vendor qualification and management programs.
• Review batch records and support product release activities.
• Conduct internal audits and participate in external supplier audits.
• Prepare for and host regulatory inspections and assist with inspection responses.
• Manage and mentor QA personnel, ensuring timely completion of daily activities.
• Review and track customer complaints, quality documentation, and regulatory updates.
• Collaborate with cross-functional teams and senior management to maintain quality standards.

Qualifications

• Bachelor's degree in Chemistry, Biology, Chemical Engineering, or a related scientific field.
• Advanced degree in Science, Regulatory Affairs, or Quality Assurance preferred.
• 10–15 years of experience in the pharmaceutical industry or a related field.
• Strong knowledge of cGMP, GLP, and pharmaceutical quality systems.
• Experience with CAPA, change control, investigations, and regulatory compliance.
• Experience reviewing analytical laboratory data and batch records.
• Previous laboratory testing and management experience preferred.
• ASQ certifications are a plus.
• Strong leadership, communication, organizational, and problem-solving skills.
• Ability to work independently and manage multiple priorities in a fast-paced environment.
• Willingness to travel up to 15–20% as needed.

Preferred Skills

• Pharmaceutical Quality Assurance
• cGMP & GLP Compliance
• Quality Management Systems (QMS)
• CAPA & Change Control
• Regulatory Inspections & Audits
• Analytical Data Review
• SOP Development
• Vendor & CDMO Oversight
• Team Leadership & Continuous Improvement

Benefits

• Health Insurance
• Dental Insurance
• Vision Insurance
• Paid Time Off
• Career Growth Opportunities