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Director, Quality Assurance
Advion BioServices

Description:

The Director, Quality Assurance (QA) is responsible for establishing and maintaining quality standards and ensures that corporate quality is consistent with client and regulatory agency expectations and requirements. This position is responsible for successful planning and implementation of quality improvement projects, departmental budget, regulatory compliance training, and quality assurance unit (QAU) staff training. The Director, QA has responsibility for research, formulation, and implementation of strategically aligned quality programs to positively impact company performance. Providing clear direction to the QAU team that ensures the quality programs of Advion are consistent with industry trends and expectations is a responsibility of this position. 

PRINCIPAL RESPONSIBILITIES:

• Improves the quality and efficiency of company operations. Develops, evaluates and supports process and procedural improvements that are consistent with client and regulatory agency expectations.
• Works with all groups generating data submittable to regulatory bodies to provide the required quality assurance support. Sets QA priorities relative to all project priorities. Monitors the QAU staff performance to ensure priorities are followed and deadlines are met.
• Relays and implements regulatory agency rules and guidelines to provide defensible compliance to these regulatory requirements while providing flexibility to meet client needs and business goals. Stays current with industry trends and developments through active involvement with external QA groups.
• Leads audits and/or inspections of all laboratory facility, process, and study data generated from such to ensure regulatory compliance. Serves as the primary escort and coordinator of inspections by external visitors and regulatory agencies.
• Reviews all SOPs to ensure compliance to regulatory requirements and established company procedures.
• Participate in computer validation projects. Directs and supervises the QAU’s role in all computer systems validation projects.
• Provides feedback to senior and executive management regarding quality matters or compliance departures.

Requirements:

• A Bachelor’s degree in related field and relevant experience with significant progressively responsible experience (five or more years) required.  Previous experience working in a CRO is highly desirable.  An advanced degree is a plus.
• Must have regulatory experience.
• Affiliation with professional institutes and organizations highly desirable.