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Job #03000

About our client Our client, a world-leading CRO, provides a broad range of services to the pharmaceutical, biotech and healthcare industries for the development and commercialization of various therapeutics. Position Location Associate Director of Quality Assurance San Diego, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee and coordinate the GCP QA program for assigned customer projects at a regional and/or global level 2) Provide support in the promotion as well as assessment of compliance with regulations, guidelines and operating procedures among sites within the region 3) Act as Line Manager for one or more QA staff 4) Provide guidance, interpretation, support, training and key input to Clinical Development Operational staff on interpretation of GCP regulations, guidelines, corporate standards and policies 5) Host customer audits and participate in review of corrective action plans 6) Recommend systems for audit 7) Write systems and procedures 8) Audit plans and coordinate scheduling, conduct, reporting and closure of internal systems as well as procedure audits 9) Plan, schedule, conduct, report and close audits of clinical research activities in any of the countries involved with corporate contracts 10) Serve as Global QA contact for assigned customers and company functional areas 11) Oversee documentation, reporting and closure of compliance issues 12) Support Director in proposal reviews and reporting QA metrics 13) Conduct trend analysis of audit results and provide QA management with initial root cause analysis 14) Ensure proper coordination of customer-initiated audits and mock regulatory inspections 15) Manage regulatory facility inspections 16) Recommend staff management actions in accordance with the organization’s policies and applicable laws 17) Train, coach and mentor employees 18) Plan, assign and direct work 19) Appraise performance and guide professional development 20) Reward and discipline employees 21) Address employee relations issues and resolve problems Requirements 1) Bachelor’s/primary degree in Life Sciences or medically-related field preferred 2) 7 – 10 years of QA experience in pharmaceutical, technical or a related area 3) Minimum 3 years of management experience or equivalent combination of education, training and experience 4) GCP quality assurance experience 5) Knowledge of word-processing, spreadsheet and database applications 6) In-depth knowledge of pharmaceutical research and development processes as well as regulatory environments 7) Understanding of quality assurance processes and procedures 8) Excellent problem-solving, risk analysis and negotiation skills 9) Superb interpersonal skills 10) Excellent organizational, communication, team-orientation and leadership skills 11) Ability to influence and guide others