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Manager Clinical Quality Control, Analytical Testing

Company: Seqirus
Location: Holly Springs
Posted on: August 7, 2022

Job Description:

Job Description Job Summary: The Manager of Analytical Testing is responsible to define and implement the strategy to utilize a lean organization to successfully support and maintain cGMP analytical testing of pre-clinical and clinical trial material using complex and challenging methods within an accelerated timeframe. The responsibility of the position is to oversee clinical trial cGMP analytical testing needs at the Holly Springs site including clinical raw materials, components, intermediates, drug substance, final products, and stability originating internally or from external contract manufacturing operations (CMOs) and or suppliers. This individual is responsible for proactively managing the Clinical QC analytical testing lab to ensure adherence to all required processes and procedures. This position is based in Holly Springs, NC Major Accountabilities: Ensure adherence to phase appropriate clinical Quality Control processes and procedures Ensure adherence to clinical phase testing processes and procedures consistent with regulatory requirements and corporate standards for testing clinical trial material. Provide QC oversight and approval of cGMP QC documents (change controls, deviations, CAPAs, procedures, etc.). Provide Oversight of Quality Control Analytical Testing of for Clinical Trial Material Collaborate with internal and external partners to ensure compliant, timely and successful testing supporting clinical product release and stability. Provide technical and operational leadership for the analytical testing team, implementing new operational models that improve the efficiency and compliance of the team. Partner with quality assurance and Technical Development to proactively identify and mitigate issues/concerns. Continuously improve quality control processes to reduce cost and improve quality Collaborate with business partners including quality leaders, functional leadership, clinical supply chain leadership and others to identify improvement opportunities. Provide Quality Control team leadership Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve. Quality Control Issue and Risk Management Represent Seqirus during audits and inspections Minimum Requirements: Bachelor---s degree in life sciences required; advanced degree preferred Minimum of 7 years--- experience in a pharmaceutical or biopharmaceutical company in roles with increasing responsibility in quality management. Minimum 6 years of managerial experience preferred Experience working in a highly regulated GMP environment as it applies to laboratory and stability functions Experience in preparing and complying with required regulatory guidelines including inspection readiness and follow-up. Experience with testing methods and processes including raw materials testing, stability testing, and sample management. Experience with assay development and validation techniques. Experience with implementing root cause analysis and effective investigation practices. LEAN experience preferred Our Benefits Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus. About Seqirus Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus. We want Seqirus to reflect the world around us As a global organization with employees in 35 countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at Seqirus. Do work that matters at Seqirus Watch our ---On the Front Line--- video to learn more about Seqirus

Keywords: Seqirus, Cary , Manager Clinical Quality Control, Analytical Testing, Executive , Holly Springs, North Carolina

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