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Job #02645

About our client Our client is a rapidly growing pharmaceutical company headquartered in San Francisco that is focused on the development and commercialization of cancer therapeutics. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. They continue to be well positioned financially to pursue multiple product candidates in parallel with the goal of bringing new treatment options to cancer patients as quickly as possible. Position Location Senior Quality Assurance Specialist San Francisco, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Perform a wide variety of activities to ensure compliance with applicable regulatory requirements 2) Draft regulatory submissions (APRs), oversee change control systems, develop quality systems, review documentation, conduct audits and perform training 3) Ensure timely processing of Change Control Requests (CCR) 4) Track CCRs and associated action items 5) Prompt others regarding upcoming deadlines 6) Provide senior management with insightful metrics regarding the performance of CC System 7) Generate submission-ready reports for approved changes 8) Review CMO-generated changes 9) Monitor the central receiving account for incoming ECCs 10) Process ECC items from a variety of (outside) sources (thus differing formats) 11) Ensure timely distribution to internal reviewers and prompt as deadlines are reached 12) Provide accurate and legible response to the originating sources 13) Write complex documents with multi-department input 14) Develop a quality system 15) Identify system deficiencies to correct complex system issues 16) Perform technical review of validation protocols and report for non-specified discrepancies, completeness and GMP compliance 17) Author annual product review and regulatory submissions (as requested) 18) Participate with the Internal Audit Team in auditing procedures and systems to assess and improve compliance with cGXPs and Standard Operating Procedures 19) Provide guidance and verify implementation of corrective actions 20) Lead external audits of raw-material suppliers and service providers 21) Participate in preparing and hosting audits by potential partners, consultants and regulatory agencies 22) Collaborate with functional groups to evaluate and address complex issues such as technical complaints, CAPA and failure investigations 23) Assist in designing cGMP training to ensure compliance with regulatory requirements 24) Act as back-up for presenting new employee orientation Requirements 1) Bachelor's degree in a scientific discipline along with 8 – 10 years of experience in quality assurance or a related field/Master's degree with 5 – 8 years of experience 2) 1 – 2 years of auditing experience 3) CQA a plus 4) Experience in quality control or manufacturing discipline within the pharmaceutical or biotech industry a plus 5) Regulatory submission experience, particularly Annual Product Reports or CMC section authorship 6) Ability to interpret cGMP regulations 7) Keen attention to detail 8) Ability to prioritize and coordinate activities to meet deadlines 9) Ability to work effectively with people and communicate negative information and obtain positive results 10) Strong ability to influence project teams and individuals in other departments 11) Good investigational, problem-solving and organizational skills 12) Superb project management and communication (verbal and written) skills 13) Good presentation skills 14) Willingness to take a leadership role regarding QA matters