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Sr. Manager, Validation - Validation, CDMO, Good Manufacturing Practices, EU regulations

Company: Talent Search PRO
Location: Mountain View
Posted on: July 29, 2022

Job Description:

QUALIFICATIONS:Minimum of a Bachelors' degree in relevant discipline and strong track record (7+ years) in cell therapy, biologics or related field5+ years in management position in a dynamic, fast growth life sciences environment5+ years of Validation (Method, Equipment Qualification, etc.) experience.Extensive knowledge regulatory requirements, Good Manufacturing Practices (GMPs) and EU regulations.Working knowledge of CDMO business operations and modelsExperience in successfully coordinating across several complex functions to ensure comprehensive and consistent development, sale, delivery and support of products and/or servicesExperience with the preparation and delivery of reports and/or presentations/communications.COMPETENCIES/CANDIDATE PROFILE:Advanced technical understanding of Validation/Qualification Requirements and concepts as the apply to ATMPs, Biologics, and/or PharmaceuticalsCreative and compliant thinking for integration of the Quality SystemAdvanced knowledge validation instruments such as Kaye Validator, Tachometer, Multimeter ...etc.Ability to manage ever-changing client and business needs by prioritizing and delegating tasks, resolve inefficiencies, and re-allocate resources within the confines of the Validation department.Good inward/outward facing written and oral communication skillsStrong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environmentDriven to deliver high quality work in a timely manner and hold other team members accountable to critical timelines and deliverablesStrong business judgment and acumenAnalytical and problem-solving skillsCreative thinkingMeeting management / facilitation skills / teamworkMust have the ability to work in a team-oriented environment.

Keywords: Talent Search PRO, Mountain View , Sr. Manager, Validation - Validation, CDMO, Good Manufacturing Practices, EU regulations, Executive , Mountain View, California

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