Job Description

Must Haves:

• Bachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry) or related field; advanced degree preferred.
• 10-15 years of experience in quality assurance within the biotechnology or pharmaceutical industry.
• Proven leadership and team management skills.
• Experience in overseeing inventory management and handling deviations and CAPA processes.
• Strong knowledge of FDA regulations, GMP, and other relevant quality standards.
• Excellent problem-solving and analytical abilities.
• Strong communication and interpersonal skills.
• Detail-oriented with a commitment to maintaining high standards of quality.

Pluses:

• Master's Degree
• Biotechnology experience

Job Description:

Insight Global is seeking a highly skilled and experienced Senior Manager of Quality Assurance to join a growing pharmaceutical client in the Durham, NC area. The successful candidate will be responsible for overseeing all quality assurance activities within our biotechnology manufacturing operations, ensuring compliance with regulatory standards and driving continuous improvement in product quality.

Responsibilities:

• Lead and manage the Quality Assurance team, providing guidance, training, and development opportunities.
• Develop, implement, and maintain quality assurance policies and procedures to ensure compliance with FDA, GMP, and other regulatory requirements.
• Oversee the quality control processes, including raw material testing, in-process monitoring, and final product release.
• Conduct internal audits and manage external audits by regulatory agencies and clients.
• Collaborate with cross-functional teams, including R&D, manufacturing, and supply chain, to address quality issues and implement corrective actions.
• Monitor and analyze quality metrics to identify trends and areas for improvement.
• Ensure timely and accurate documentation of all quality-related activities.
• Oversee inventory management to ensure quality standards are maintained throughout the supply chain.
• Manage deviations and CAPA (Corrective and Preventive Actions) processes to address and resolve quality issues.
• Oversee a team of 22-25 employees, including 6 direct reports, across 24/7 manufacturing operations.
• Supervise shop floor personnel to ensure adherence to quality standards.
• Review batch records and cell banking processes to ensure compliance and accuracy.
• Review internal audits and make necessary corrections to Standard Operating Procedures (SOPs).
• Stay current with industry trends and regulatory changes to ensure the company remains compliant and competitive.
• Foster a culture of quality and continuous improvement throughout the organization.

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