Director, Quality Assurance
About The Position
The Director, Quality Assurance provides strategic and operational leadership for the Quality Assurance function, ensuring compliance with current Good Manufacturing Practices (cGMP) and applicable regulatory requirements, including FDA, DEA, and other global regulatory agencies. The role leads quality systems, regulatory inspection readiness, internal and external audit programs, supplier qualification, validation oversight, batch disposition, investigations, and continuous quality improvement initiatives. The Director partners with Manufacturing, Research & Development, Engineering, Technical Services, Regulatory Affairs, and other business functions to maintain compliant quality systems, drive corrective and preventive actions (CAPA), and ensure products, processes, facilities, and vendors meet regulatory and company quality standards. This supervisory leadership role oversees 3 direct reports and 18 indirect reports. Work takes place in office and pharmaceutical manufacturing environments, with periodic travel within manufacturing areas and to vendor or contract manufacturing sites. The position is exempt and salaried, with a stated annual pay range of $170,000 to $200,000 and eligibility for an annual bonus aligned with individual and company performance.
Requirements
- Bachelor's degree in Biology, Chemistry, Biochemistry, Pharmacy, or a related scientific discipline.
- At least 10 years of progressive Quality Assurance leadership experience in a cGMP-regulated generic pharmaceutical manufacturing environment.
- Experience overseeing Oral Solid Dosage (OSD) manufacturing, quality systems, validation, regulatory inspections, and Quality Assurance personnel.
- Extensive knowledge of cGMP, cGLP, FDA and DEA regulations, and applicable domestic and international pharmaceutical regulatory requirements.
- Comprehensive understanding of pharmaceutical manufacturing, quality assurance, quality control, validation, investigations, CAPA, change control, supplier qualification, and audit management.
- Demonstrated experience leading regulatory inspections and managing responses to regulatory observations.
- Strong knowledge of QMS and risk-based quality management principles.
- Experience interpreting and implementing regulatory guidance, industry standards, and quality compliance requirements.
- Strong analytical, problem-solving, leadership, organizational, and communication skills.
- Proficiency with electronic Quality Management Systems (eQMS), Microsoft Office Suite, and applicable quality documentation systems.
- Meet the employer's minimum English proficiency requirements.
- Be legally authorized to work in the United States for any employer; visa sponsorship or takeover of visa sponsorship is not available.
Responsibilities
- Provide strategic leadership and oversight of the Quality Assurance department to ensure compliance with cGMP, FDA, DEA, and other applicable regulatory requirements.
- Direct and maintain quality systems to support inspection readiness and regulatory compliance across manufacturing operations.
- Coordinate regulatory inspections, including FDA, DEA, customer, and third-party audits, and ensure timely resolution of observations.
- Oversee quality for manufacturing operations, contract manufacturers, contract packagers, contract testing laboratories, and suppliers.
- Develop and maintain quality compliance strategies, policies, procedures, and systems aligned with business objectives and regulatory requirements.
- Lead CAPA activities and ensure investigations are effective and corrective actions are implemented and sustained.
- Review and approve validation protocols and reports, quality system documentation, investigations, deviations, change controls, and other QMS records.
- Make independent batch disposition decisions, including approving or rejecting manufactured products based on quality standards.
- Ensure deviations, nonconformances, and manufacturing investigations are evaluated, documented, and resolved in accordance with regulatory expectations.
- Develop, implement, and manage the internal self-inspection program to assess compliance, identify risks, and drive improvement.
- Oversee vendor qualification and auditing programs, including audits of suppliers, packaging vendors, contract manufacturers, and contract laboratories.
- Collaborate with Research & Development, Manufacturing, Engineering, Technical Services, and Regulatory Affairs to establish compliant processes for product development and commercial manufacturing.
- Interface with regulatory agencies and external stakeholders on quality matters and represent the organization during inspections and compliance activities.
- Facilitate implementation of quality systems, technologies, and process improvements to enhance compliance and operational efficiency.
- Chair or participate in Site Management Review Board (MRB) meetings and provide quality leadership for organizational decision-making.
- Lead, coach, manage performance, and support professional development of Quality Assurance personnel while fostering a culture of quality and regulatory compliance.
- Evaluate training needs and ensure personnel maintain competencies related to cGMP regulations and quality systems.
Benefits
- Annual bonus aligned with individual and company performance.
- 401(k) matching, vested immediately.
- Medical insurance.
- Dental insurance.
- Vision insurance.
- Employee Assistance Program.
- Employee discount through Life Mart.
- Flexible Spending Account and Dependent Care Account.
- Paid holidays.
- Paid Time Off.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
