Director of Quality

The Director of QA will oversee QA and Microbiology operations for the New Jersey GMP manufacturing sites. This leader will ensure that all processes, systems, and activities comply with cGMP, GLP, and global regulatory requirements, while maintaining the highest standards of product and process quality. The role is critical in leading quality oversight, continuous improvement initiatives, regulatory compliance, and fostering a culture of quality.

• Develop, implement, and maintain robust QA and microbiology policies, procedures, and systems to ensure compliance with cGMP, GLP, and global regulatory standards.
• Lead QA oversight for manufacturing operations, ensuring consistent application of quality standards throughout the product lifecycle.
• Manage microbiological testing activities, environmental monitoring, and aseptic process support to ensure microbiological control across operations.
• Direct quality review and approval of batch records, deviation investigations, CAPA, and change controls.
• Prepare for and lead regulatory inspections and audits, ensuring inspection readiness and effective response to findings.
• Support product release processes, ensuring all QA and microbiological criteria are met.
• Drive continuous improvement initiatives to enhance compliance, efficiency, and product quality.
• Build, lead, and mentor a high-performing QA and microbiology team, including recruitment, training, and performance management.
• Ensure effective documentation practices and support the development of SOPs and training materials aligned with current regulatory expectations.
• Collaborate cross-functionally with manufacturing, technical operations, and validation teams to ensure integrated quality oversight.

• Bachelor's degree in Microbiology, Biology, Chemistry, or a related scientific discipline; an advanced degree is a plus.
• Minimum of 15 years of experience in the pharmaceutical or biotechnology industry, with at least 5-10 years in QA or Microbiology leadership.
• Demonstrated expertise in GMP regulations, microbiology testing, contamination control, and regulatory agency expectations.
• Successful track record managing regulatory inspections and leading QA and microbiology functions in a GMP environment.
• Previous experience in Quality Control, Compliance, and Auditing is strongly preferred.
• Strong leadership, communication, and problem-solving skills, with experience managing teams across multiple sites.