QA Director

About McKinney Specialty Labs

McKinney Specialty Labs is an innovative scientific organization that draws upon decades of extensive expertise in testing nicotine and other aerosolized products. We employ subject matter experts with extensive scientific knowledge, utilize robust and validated analytical methods, and offer testing flexibility to meet the diverse needs of our clients.

Our mission is to deliver best-in-class product testing and global regulatory science solutions to our clients through our experience, people and technology. We accomplish this by offering our clients the highest quality testing services in a state-of- the-art facility, all conducted according to our Values: Excellence, Collaboration, Integrity, Innovation, and Respect.

We are a new and growing company located in Richmond, Virginia. We offer competitive pay and a comprehensive benefit package, including medical, dental, vision and 401 (k).

To learn more, please visit our company website: https://mckinneysl.com/

Position Overview:

The Director of Quality Assurance (QA) will oversee and lead the Quality Assurance program for our Chemistry and Good Laboratory Practice (GLP) compliant in vitro laboratory. This position ensures full compliance with regulatory requirements, internal quality standards, and client expectations while driving continuous quality improvement.

The QA Director will manage the QA team, oversee audits and inspections, maintain compliance programs, and ensure laboratory data integrity for in vitro toxicology and analytical chemistry studies supporting regulatory submissions to US FDA and international regulatory authorities. The QA Director will report to the CEO.

This position will be onsite in Richmond, VA. Ability to be onsite on a daily basis is required.

Essential Duties and Responsibilities:

• Lead and mentor the Quality Assurance team, fostering a culture of quality, compliance, and continuous improvement.
• Provide training on GLP/GMP requirements, data integrity, and quality best practices to laboratory staff.
• Ensure laboratory operations comply with GLP, FDA, OECD, ICH, and ISO 17025 regulatory guidelines.
• Develop, implement, and oversee Quality Management Systems (QMS) to maintain regulatory compliance.
• Lead internal quality audits, regulatory inspections, and client audits, ensuring timely resolution of findings and CAPAs (Corrective and Preventive Actions).
• Review and approve Standard Operating Procedures (SOPs), study protocols, data reports, and validation documents.
• Oversee data integrity, documentation practices, and electronic records compliance (21 CFR Part 11).
• Work closely with laboratory personnel to identify and mitigate compliance risks.
• Manage deviation investigations, out-of-specification (OOS) results, and non-conformance reports.
• Implement and monitor change control procedures to assess and document process modifications.
• Serve as the primary QA liaison to clients during inspections and submissions.
• Interface with clients and stakeholders to ensure quality expectations are met for contract research projects.

Necessary Qualifications:

To perform this job successfully, individuals must be able to perform each duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the duties and responsibilities.

• Bachelor’s or Master’s degree in Science, or a related field.
• 10 years of experience in Quality Assurance, with at least 5 years in a leadership role within a GLP, or ISO-accredited laboratory.
• In-depth knowledge of GLP regulations, regulatory compliance standards, and quality systems.
• Experience managing QA in an in vitro toxicology and analytical chemistry laboratory.
• Proven expertise in quality audits, inspections, CAPA management, and data integrity programs.
• Proven leadership experience, including team building, mentorship, and performance management.
• Excellent communication skills with the ability to present complex data to scientific and non-scientific audiences.
• Superior time management abilities

Preferred Skills:

• Certification in Quality Assurance (e.g., ASQ, RQAP-GLP, Six Sigma, or similar QA certification).
• Experience with electronic quality management systems (eQMS) and 21 CFR Part 11 compliance.
• Knowledge of OECD GLP, FDA CTP (for nicotine/tobacco studies) guidelines.
• Prior experience working with contract research organizations (CROs) or regulatory laboratories

The above statements are intended to describe the general nature of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties and skills required of employees so classified.

Application Process:

McKinney Specialty Labs is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. McKinney Specialty Labs does not discriminate in hiring or employment practices based on race, color, religion, gender, age, sexual orientation, marital or familial status, national origin, non-job-related disability, or status as a veteran.

If you are looking to make an impact in a dynamic and visionary company, we invite you to apply for this opportunity at McKinney Specialty Labs.