Sr. Manager, Validation - Validation, CDMO, Good Manufacturing Practices, EU regulations
Company: Talent Search PRO
Location: Mountain View
Posted on: July 29, 2022
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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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