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Job #02923

About our client Our client is a young venture-backed biotechnology company that focuses on the development and commercialization of therapeutics for CNS disorders. The company has a marketed product and an exceptional management team, yet they remain small enough where committed people can make a visible impact on the organization's future direction. This is a strong opportunity for someone that wants to put their drive and initiative to work! Position Location Senior Manager Quality Assurance Compliance San Francisco, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee compliance programs and activities 2) Handle product return and product complaints 3) Oversee CMO 4) Manage internal and external audits 5) Ensure vendor quality 6) Prepare for and facilitate inspections 7) Manage annual product review reporting 8) Oversee lot disposition program 9) Manage QA tasks to support equipment calibration, equipment/utility validation and preventive maintenance as well as facility shutdown/restart processes 10) Handle the disposition of manufacturing supplies, raw materials, intermediates and product 11) Manage QA role in the handling and disposition of manufacturing supplies and raw materials 12) Investigate compliance and product quality issues 13) Facilitate Material Review Board meetings 14) Determine and collect information as well as metrics to support management review program 15) Guide Operations staff regarding compliance and product quality issues 16) Identify trends and implement improvements 17) Provide intra and interdepartmental GMP training 18) Write and revise SOPs and forms 19) Provide operational support for other QA functions 20) Manage and develop staff Requirements 1) 8 years of experience in QA and 3 years of supervisory experience 2) Knowledge of and experience in US and EU cGMPs (commercial biopharmaceutical organization preferred) 3) Drug background (will not consider medical device) 4) Experience in Japanese and Korean cGMP requirements a plus 5) Experience in managing staff and group responsibilities 6) Experience in commercial manufacturing QA (not clinical stage manufacturing) 7) Excellent organizational and documentation skills 8) Superb leadership skills and the ability to collaborate 9) Excellent communication with other functional areas and sites 10) Proficient in computers (MS Word, Excel and Access) 11) Ability to provide technical solutions to difficult issues 12) Ability to work independently and in a team environment 13) Detail-oriented individual