The QA Associate Director, Compliance supports the optimization of the strategic direction for quality strategies, systems, policies, and procedures and manages the compliance training program which includes the implementation, optimization, maintenance, and assessment of company-wide training and management of support staff for a role-based electronically tracked training program as needed. In addition, this position will manage oversight for the vendor management program including maintenance of the Approved Supplier List, annual vendor reviews, and support companywide efforts to maintain acceptable levels of compliance with internal procedures, corporate requirements, and applicable regulations (i.e. FDA, EMA, etc. as applicable). The position will foster a collaborative environment and work closely with affected departments to ensure compliance by providing training modules, supporting inspections, assisting with internal audit program, product quality reviews, and key performance indicator trending.
BS, MS, or equivalent pharmaceutical/biotechnology industry experience (15+ years) with at least 10 years in a Quality function. Must be proficient in EDMS and Training Mgmt. software with a specialty in implementation and management of role-based training curricula and staff. Must have extensive experience in vendor management and the management/performance of internal audits. CBA/CQA certification preferred. Must be a dynamic, hands-on manager with a clear practical understanding of GXPs, the ability to support regulatory inspections, and to assist with the creation of training materials and modules. Experience with product quality reviews, the management of key performance indicators, and review of validations is desired. Excellent written and verbal communication skills and proficiency in Microsoft software applications. Strong Communication and listening skills required. Ability to work and communicate with all levels within the organization in a constructive and positive manner.