Associate Director, Clinical Quality Assurance- San Diego, CA

Job Category: Quality Assurance/Safety Career Level: Manager (Manager/Supervisor of Staff) The Clinical Development Services division of Quintiles has more depth of therapeutic expertise and a broader range of services than any other service provider. We conduct both US and Global trials in all therapeutic areas.  In fact, Quintiles conducts more clinical trials than anyone else in the world.  Become involved in work that improves the quality of life for people around the globe.  Let your career soar! We are seeking an enthusiastic Associate Director, Clinical Quality Assurance to join our team!Purpose:  Oversee and coordinate the GCP quality assurance program for assigned customer projects at a regional and/or global level.  Provide support in the promotion and assessment of compliance with regulations, guidelines, and operating procedures among sites within the region.  Act as line manager for one or more QA staff.  Responsibilities: Provide guidance, interpretation, support, training, and key input to clinical development operational staff on interpretation of GCP regulations, guidelines, corporate standards, and policies. Host customer audits and participate in review of corrective action plans.  Recommend systems for audit, write systems and procedures audit plans and coordinate scheduling, conduct, reporting and closure of internal systems and procedures audits.  Plan, schedule, conduct, report and close audits of clinical research activities in any of the countries involved with corporate contracts. Serve as Global QA Contact for assigned customers and Quintiles functional areas. Oversee documentation, reporting, and closure of compliance issues. Support director in proposal reviews and reporting QA metrics. Conduct trend analysis of audit results and provide QA management with initial root cause analysis Ensure proper coordination of customer-initiated audits and mock regulatory inspections, and manage regulatory facility inspections. Recommend staff management actions in accordance with organization’s policies and applicable laws.  Recommendations include training, coaching, and mentoring employees; planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Prefer a Bachelor’s/primary degree in life sciences or medically related field; 7-10 years Quality Assurance experience in pharmaceutical, technical, or related area, including  GCP Quality Assurance experience. A minimum of 3 years of management experience; or equivalent combination of education, training and experience. Knowledge of word-processing, spreadsheet, and database applications. Strong knowledge of pharmaceutical research and development processes and regulatory environments. Considerable knowledge of quality assurance processes and procedures. Strong interpersonal skills. Excellent problem solving, risk analysis, and negotiation skills. Effective organization, communication, and team orientation and leadership skills. Ability to influence and guide others.