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Job #02709

About our client Our client is a rapidly growing pharmaceutical company headquartered in San Diego that is focused on the development and commercialization of small molecule therapeutics for anti-infective and oncology applications. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Associate Director Quality Assurance San Diego, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Create, support and maintain company’s quality systems in accordance with GXPs and other regulations 2) Audit external contract vendors for acceptability 3) Assess quality systems, prepare audit reports and maintain surveillance audit documentation 4) Handle contract vendor maintenance with the Purchasing Department 5) Establish/maintain quality agreements 6) Handle multiple tasks like managing QA review/approval, Master Batch Records, manufacturing and stabilizing protocols, changing controls (specifications, test methods, reference standards), stabilizing data (each time-point, including raw data) and SRID Forms 7) Manage QA disposition, execute batch record reviews, drug substance/intermediates, drug product, clinical labeling and release test records reviews as well as batch disposition 8) Create, implement, maintain and verify Internal Quality System 9) Generate and review (applicable) SOPs 10) Manage documentation files in compliance with (applicable) regulations 11) Perform and/or coordinate internal audits and assess Quality Systems 12) Manage and direct other departments in quality planning activities 13) Support preparation of reports used in quality reviews related to purchased materials and services 14) Manage and assess corporate compliance with established standards 15) Prepare summary tables of data used in monitoring product quality 16) Draft summary reports of data as per standard formats 17) Support design control changes and maintain master files 18) Assist in FDA and regulatory audits 19) Support clinical regulatory filings, in the US, EU and (potentially) Canada 20) Ensure that clinical data meet GCP standards prior to submission of filings to regulatory agencies 21) Support preparation of the department’s overall budget 22) Prepare and maintain accurate spreadsheets of departmental as well as project budgets 23) Review invoices for accuracy and completeness 24) Initiate payments for vendors 25) Handle QA management for ongoing clinical trials 26) Ensure that all data required to support regulatory submissions for EU, US and (potentially) Canada are in compliance with applicable regulations 27) Handle all clinical research activities, including internal and external training activities, CRO qualification, internal and external GCP auditing 28) Write and ensure regulatory compliance of clinical trials with regulations and quality systems 29) Ensure that highest quality and ethical standards of the company’s clinical research activities are maintained 30) Audit investigative sites, CROs and study files to ensure compliance with all applicable regulations 31) Ensure that all ongoing clinical trials are conducted in compliance with applicable codes of Federal Regulations (CFR), ICH/GCP, declaration of Helsinki, the Belmont Report, other local regulations and approved SOPs 32) Maintain and update (as necessary) clinical SOPs in compliance with approved Quality System and FDA regulations 33) Ensure that all electronic files are in compliance with applicable regulatory requirements for Electronic Data Capture (EDC) and other clinical software applications 34) Reconcile clinical supply inventory and destruction as per SOPs 35) Ensure final reconciliation of clinical product shipped to clinical trial sites 36) Evaluate and qualify CROs and in-vivo research facilities to ensure compliance with regulations specific to performing pre-clinical research to ensure that all related documentation and GLP pre-clinical activities are appropriately reviewed for GLP compliance 37) Establish and manage internal GLP systems, documentation and training Requirements 1) Bachelor’s degree/some graduate work preferred 2) Minimum 5 years of experience in the biotechnology/pharmaceutical industry 3) Knowledge of quality standards such as the FDA Quality System regulations 4) Experience in using electronic document management systems 5) Strong GCP, GLP and GMP experience 6) 10 years of quality experience, including 5 years of quality management expertise in biotech or pharmaceuticals 7) Experience in auditing manufacturing facilities and conducting analytical testing in conformance with GMPs 8) Ability to coordinate multiple tasks and work in a team environment 9) Ability to work with minimal supervision 10) Good Laboratory Practice Standards and Good Clinical Practice Standards 11) Excellent organizational and communication skills