Director, Quality Control

Select how often (in days) to receive an alert:The Director of Quality Control will lead the Quality Control and Analytical functions for release, stability, raw material testing and method validation/transfer functions in compliance with FDA and other international regulatory requirements for research, pre-clinical, clinical and commercial pharmaceutical products at Bachem.What you will doMaintain the quality control laboratories and stability program per FDA cGMP parts 210 and 211, ICH Q7 and Q9 requirements for drug substances and ISO 13485 for raw materials used in device and diagnosticsDevelop annual master analytical validation plan and ensure validations are conducted per ICH guidelines, including cleaning validations and analytical test method validationEnsure continuous improvement and effectiveness of the quality control labsOversee and conduct cGMP, ICH and ISO stability programs to comply with regulatory requirementsOversee work of direct reports; distribute workload, and cross-train staff on different quality areas. Interview, hire, train, develop and manage employeesOversee the document control function, including issuing records, maintaining electronic and hard copies of master records, and maintaining hard copies of history recordsInvestigate and document out-of-specification results and deviations during product testingAssure and oversee QC laboratory testing and documentation under cGMP conditionsMaintain laboratory performance matrices and other activities as assigned.QualificationsMaster’s degree in chemistry or chemical engineering (or equivalent) with a minimum of 5 years’ work experience in GMP manufacturingBachelor’s degree in chemistry or chemical engineering (or equivalent) with a minimum of 8 years’ work experience in GMP manufacturingPhD in Chemistry/Chemical Engineering (or equivalent) with a minimum 1 year of relevant work experienceAt least 4 years management experience including people management at a leadership role.Experience with peptides and oligomer manufacturing processes (preferred)Experience with Master Control (preferred)Experience with SAP (preferred)Knowledge of cGMP and FDA regulationsKnowledge in Method Qualification/Validation and Analytical TransfersKnowledge in routine QC functions including OOS/OOT, Deviations, CAPA’s and Change Controls.Experience with overseeing regulatory audits (preferred)Excellent written and oral communication skillsBasic computer knowledge, including Microsoft Word, Excel and PowerPointFamiliarity with laboratory electronic systems including LIMS/ELNAbility to effectively organize, multitask, and work in a fast-paced, deadline driven work environmentAbility to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues.Detail oriented with the ability to troubleshoot and resolve complex scientific problemsAbility to work independently and manage one’s time effective time managementCommunicate effectively and ability to function well in a team environment

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