Director, Quality Assurance

The Director, Quality Assurance (QA) proactively develops, leads, and drives the execution of the organization's global quality assurance strategy. They establish and implement policies, procedures, specifications, the Quality Management System (QMS), direct QA staff and manage the department's daily business.

The Director, QA partners with the organization on continuous process and systems improvements, maintaining ATCC's industry leadership position in quality. The Director QA leverages data, regulatory requirements, and in-depth knowledge of organizational objectives to drive improvement activities. They establish and assure adherence to budgets, schedules, work plans, and performance requirements.  Decision making and establishment of Quality Vision are key components of this position, and these have a significant impact on the overall success of the organization.

ATCC's culture and mission necessitate a collaborative and coaching approach approach from QA. An individual who is skilled in collaboration, negotiation and who exhibits high EQ can be highly successful at ATCC.

The director, QA has responsibility for ATCC QA globally. The role's “home base” can be located either at ATCC's Gaithersburg, MD site or at ATCC's Manassas, VA site. Support of both sites on a weekly cadence is required. Hybrid situations are negotiable.  The Director, Quality Assurance reports to ATCC's Chief Quality, Regulatory and Safety Officer.

Responsibilities

1. Manage ATCC's Quality Assurance (QA) group. Develop and build the group's capabilities to Support ATCC's product offerings, compliance and regulatory strategies.
2. Ensure corporate compliance with all business-relevant ISO and cGMP standards.
3. Partner with the ATCC business and operational departments to drive KPI's, accountability, and RACI.
4. Identify improvement opportunities and garner corporate support for Quality improvement initiatives.
5. Continue to develop ATCC's QA validation/engineering program, Quality Management System (QMS), supplier and post-market QA, and RCCA programs.
6. Enhance ATCC's capabilities for quantitative process analysis and data-driven improvement activities.
7. Define and oversee ATCC's quality goals each year.
8. Oversee ATCC's QA-Management engagement including executive leadership team and CEO interactions.

Qualifications

Education and Experience:

• Bachelor's degree in science or engineering and 12 or more years' experience, including 6 or more years' supervisory experience or equivalent experience.  
• Previous management, supervision of a QA team is required.
• Direct experience working with regulators and/or accreditation & certification bodies is a must.
• Experience working in a complex, matrixed environment is strongly preferred.
• Strong QA and/or Operations experience in highly regulated environments such as bioprocessing, med device, life sciences, aerospace, automotive are strongly preferred.
• Demonstrated mastery of the ISO9001 standard plus experience in an “advanced” standard such at ISO13485, TS16949, AS9000, or cGMP required.
• Experience hosting customer and regulatory audits required. Formal training/certification in auditing is desirable.
• ASQ certification/credentials preferred.
• Experience using OpEx tools, six sigma or LEAN, structured problem solving preferred.

Other Duties:

• Perform other duties as assigned.

Founded in 1925, ATCC is a non-profit organization with a mission to acquire, authenticate, preserve, develop, standardize, and distribute biological materials and information for the advancement and application of scientific knowledge.

ATCC is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.