Director of Quality Assurance (QA)
Location: Lincolnton, NC
Job Type: Direct Hire
Company: Openwork
Salary: 0
Category: Quality Operations
Job Description Apply Now
Director of Quality Assurance (QA)
The Director of Quality Assurance (QA) plays a vital leadership role in supporting quality initiatives and ensuring that compliance with current Good Manufacturing Practices (cGMPs) is maintained across the organization. This position is integral to upholding the highest standards of product quality, safety, and regulatory compliance within the pharmaceutical or life sciences industry. The Director of Quality Assurance (QA) is responsible for guiding the Quality organization, developing staff, and implementing effective systems and processes to meet or exceed regulatory expectations.
As a Director of Quality Assurance (QA), you will be expected to provide strategic direction and operational oversight over multiple quality functions, including Quality Assurance, Quality Systems, Quality Affairs, and Quality Control. Your leadership will be essential in making decisions that impact the organization's compliance status, business risk, and ongoing product excellence. You will collaborate with cross-functional teams and maintain strong relationships with regulatory agencies to ensure seamless execution of regulatory inspections and industry-standard practices.
Working as a Director of Quality Assurance (QA) offers an opportunity to make a significant impact within the pharmaceutical and life sciences sector. The role requires a forward-thinking approach, a deep understanding of both analytical and microbiological methodologies, and the ability to mentor and develop a high-performing team. The organization values commitment to quality, continuous improvement, and long-term strategic growth, making this position ideal for professionals seeking to advance their careers in quality leadership and regulatory compliance.
The Director of Quality Assurance (QA) role is essential for driving the company's mission to deliver safe and effective products. If you are passionate about quality, compliance, and operational excellence, we encourage you to apply now by clicking the job application button to join a dynamic and mission-driven organization.
Director of Quality Assurance (QA) - Summary- Lead the Quality organization in upholding cGMP compliance and fostering a culture of quality excellence.
- Drive strategic and operational decisions that impact quality outcomes and organizational direction.
- Mentor, develop, and guide Quality Assurance, Quality Systems, Quality Affairs, and Quality Control teams.
- Oversee regulatory inspection readiness and execution, ensuring compliance with FDA and other regulatory agencies.
- Establish and maintain relationships with key opinion leaders and regulatory officials.
- Provide leadership and strategic direction to the Quality department.
- Mentor and develop staff within Quality Assurance, Quality Systems, Quality Affairs, and Quality Control.
- Make critical decisions on quality-related strategic and operational matters.
- Direct activities and outcomes of Quality Assurance with organization-wide and product-wide impact.
- Set and align departmental goals with corporate objectives to further the mission and vision of the company.
- Oversee, prepare, coordinate, and execute all regulatory inspections, including those conducted by the FDA and other agencies.
- Develop and maintain external relationships with regulatory officials and key opinion leaders in the field.
- Direct the implementation of systems, practices, and processes for effective review of product design and manufacturing changes.
- Lead the response to significant deviation events that could affect compliance or business risk.
- Supervise analytical and microbiology laboratories, including raw material/component release, in-process testing, finished product release, stability testing, and environmental monitoring.
- Review and approve essential quality documents such as deviations, annual product reviews, customer complaints, validation protocols/reports, and change controls.
- Competitive base salary commensurate with experience and qualifications.
- Comprehensive benefits package available.
- Opportunities for performance-based incentives and long-term career advancement.
- Supportive company culture focused on professional growth, collaboration, and innovation.
- Bachelor's degree or higher in life sciences, engineering, or business.
- Over 15 years of pharmaceutical quality experience in manufacturing, CMO, or technology-driven life sciences companies.
- Demonstrated proficiency in analytical and microbiological methodologies, especially for semi-solid drug products and excipients.
- Extensive knowledge of cGMP and regulatory compliance requirements.
- Proven history of successfully leading quality and analytical teams and driving strategic growth initiatives.
- Experience managing the product development lifecycle, including concept, design, implementation, verification, and validation for commercialization.
- Strong leadership, influence, and cross-functional teamwork skills.
- Experienced leader with a strategic mindset and hands-on approach to quality management.
- Proactive problem-solver with strong decision-making abilities in high-impact situations.
- Excellent communicator, able to effectively interact with regulatory authorities and internal teams.
- Skilled mentor and developer of talent within quality-focused teams.
- Adaptable professional who thrives in dynamic, fast-paced pharmaceutical or life sciences environments.
- This Director of Quality Assurance (QA) position offers a unique chance to contribute to the ongoing success and reputation of a leading organization in the pharmaceutical or life sciences industry.
- Join a collaborative and forward-thinking workplace committed to high standards of quality and regulatory compliance.
- Apply now to take on a rewarding leadership role—click the job application button to start your application process today.