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Job #03482

About our client Our Client is a leading producer of therapeutic peptides for pharmaceutical and biotech companies. Our Client operates from two locations in Brussels, Belgium and in Torrance, California. They are committed to serving the pharmaceutical and biotech industries with the production of cost effective and high quality bulk peptide APIs, based on close and long term relationships with the customers. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the longterm professional development of its employees. Position Location Quality Assurance Manager California Salary Highly competitive package, commensurate with experience Responsibilities 1) Proficient in current FDA regulations and ICH guidelines applicable to API's 2) Accountable for managing the accurate and timely execution of all aspects of the QA department 3) Accountable and responsible for ensuring GMP compliance throughout the company 4) Responsible to inter phase with customers and FDA officials during audits and as needed 5) Responsible for reviewing and approving all related documents in QA/QC/Production including but not limited to data from testing (in-house and outside testing), notebooks, log books, finished product data files, raw material release files, notebooks, Master batch records, executed batch records for release of drug substance, deviations, CAPA/investigations and out-of-specification reports 6) Responsible for generating, maintaining, and controlling all related SOP's 7) Responsible for writing "chemistry manufacturing control" documentation packages for customer filings and drug master files as needed 8) Responsible for carrying out responsibilities in accordance with the Organization's policies and procedures enforcing cGMP regulations within the laboratory and ensuring that staff is properly trained and comprehends all updated SOP's, and test methods 9) Responsible for internal audits 10) Troubleshoot potential issues that may arise during the project execution 11) Confirm client directives are executed accurately and consistently 12) Responsible for final reports released & delivered to clients for compliance with verbal/written instructions and confirm receipt of final reports by clients 13) Prioritize schedules with Production Department and VP of Operations as required 14) Responsible for hiring and evaluating the performances of all QA personnel as required 15) Responsible for cGMP training of employees 16) Perform related duties as assigned Requirements 1) Proficient in Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), International Conference on Harmonization (ICH) and other regulatory requirements 2) Ability to implement goals, objectives and practices for effective, efficient and cost effective management of allocated resources 3) MS with at least 8+ years in QA experience 4) Analyzing problems, identifying alternative solutions, and implementing recommendations for resolution of problems 5) Handling multiple projects and tasks 6) Possess good oral and written communication skills and ability to work in a team