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Job #02861

About our client Our client is a leading drug company with close to $10B in sales and over 10,000 employees worldwide. The company has strong financials, an experienced management team and a loyal customer base. They have developed an industry-wide reputation for a positive work environment and an aggressive training program that ensures employees are up-to-date on current trends and best practices. This is a strong opportunity for someone that wants to put their drive and initiative to work. Position Location Quality Assurance Manager – Contract Manufacturing (Small Molecule) San Francisco, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide quality oversight and expertise for manufacturing small molecule API and drug product at contract manufacturing organizations (CMOs) 2) Build strong relationships with internal operation units and external CMOs as well as partners 3) Participate in due diligence visits to assess CMOs quality systems for processing clinical products 4) Negotiate and maintain quality agreements with selected CMOs and ensure that the requirements are fulfilled 5) Ensure that product-specific requirements are met 6) Follow-up on any corrective action identified as a result of company audits 7) Ensure processing of clinical supplies of company small molecule and ADC products at CMOs is conducted in accordance with cGMP 8) Write facility/process GMP commissioning plans and ensure that they are executed successfully 9) Review and approve master batch records for compliance to clinical trial protocols, regulatory filings, pertinent product requirements (e.g. storage/handling, sampling, etc.) and cGMP compliance 10) Perform person-in-the-plant activities (as required) during GMP manufacturing 11) Participate in the review of CMC sections of regulatory filings 12) Willingness and ability to travel (up to 25%) 13) Participate in the design, implementation and maintenance of quality systems for small molecules for execution of the above functions Requirements 1) BS/BA in a relevant scientific discipline or equivalent 2) Minimum 5 years of relevant pharmaceutical experience in small molecules 3) Minimum 2 years of direct experience in QA (pharmaceutical operations) 4) Experience in contract manufacturing audits (supplier quality) 5) Experience in API manufacturing and/or solid dosage forms preferred 6) Working knowledge of QA and manufacturing principles 7) In-depth knowledge of US cGMPs with ability to apply sound judgment and decision-making skills to evaluate product release 8) Understanding of applying GMPs appropriate for particular stage of development 9) Knowledge of worldwide cGMP regulations and ICH guidelines (ICH Q7) 10) Excellent interpersonal and negotiation skills 11) Excellent communication skills (written and verbal) 12) Willingness and ability to travel – up to 25%