To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #02974

About our client Our client is a biopharmaceutical company based in San Diego. They focus on in-licensing, developing and commercializing therapeutics for the treatment of cancer and infectious disease. Coupled with these is an experienced management team with significant product development, clinical, regulatory, finance and business management expertise. This is a great opportunity for the right individual to join a dynamic company! Position Location Associate Director of Quality Assurance San Diego, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage quality-related activities for drug substances and products 2) Develop and maintain quality system to meet applicable regulatory requirements (e.g. FDA and EMEA) 3) Maintain GxP compliance internally 4) Develop and maintain company SOPs, specifications and change control 5) Oversee quality of CROs as well as audits of analytical testing laboratories, drug substance and drug product manufacturers 6) Review batch records 7) Prepare for and participate in PAIs 8) Support in-house GMP activities such as inventory, sampling and storage of GMP materials (samples, labels, API and drug product) 9) Maintain employee training records as well as ensure job specific training is provided and documented 10) Operate to the highest ethical and moral standards 11) Comply with company policies and procedures 12) Adhere to quality and safety standards set by regulations as well as company policies, procedures and mission 13) Communicate effectively with supervisors, colleagues and subordinates 14) Assist in unrelated job areas when called upon and be committed to team effort 15) Provide knowledge-based expertise in related areas that can be applied to meeting strategic goals Requirements 1) Bachelor’s degree (Life Sciences preferred) 2) 8+ years experience in the pharmaceutical/biotech industry, with at least 4 years in a management role within Quality Assurance 3) Working knowledge of US and ex-US regulatory guidelines 4) Excellent organizational and communication skills 5) Ability to work well in a deadline-driven environment 6) Ability to support multiple projects simultaneously 7) Willingness and ability to travel (as needed)