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Quality Assurance (QA) Manager Job
Eingestellt von Yoh
Gesuchte Skills: Client
Projektbeschreibung
TOP SKILLS SHOULD YOU POSSESS:
- Quality and compliance guidance
- CAPA
- Root cause analysis
WHAT YOU'LL BE DOING:
- Provide quality and compliance guidance for the development and implementation of corrective and preventive actions; monitor their status and timely closure
- Ensure adequate regulatory inspection and audits preparation
- Provide leadership and guidance during the development and execution of corrective and preventive actions (CAPA)
- Lead formal investigations of issues as they arise, ensuring timely escalation to line management if critical observations are not resolved in due course
- Represent QA in interactions with internal and external contacts and Health Authorities, as appropriate
- Ensure that compliance commitments are fulfilled on time
- Provide interpretation of GCP regulations and company standards, guidelines, policies and procedures to personnel
- Closely cooperate with the Development QA Quality Systems Excellence, Auditing and Compliance Excellence groups to ensure consistency of quality and compliance activities and effective communication..
WHAT YOU NEED TO BRING TO THE TABLE:
- Ten (10) plus years of experience in clinical development and the pharmaceutical industry, preferably with at least 3 years in Quality Assurance/Compliance roles.
- Thorough and extensive knowledge of international GCP regulations including FDA/EU GCP, ICH, pharmacovigilance, new drug regulations, other key HA guidance's, and current industry practice
- Capable of working independently as well as part of a cross-functional team demonstrating the ability to influence and create alignment across multiple functional areas.
- Considerable organization awareness (eg interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams
WHAT ARE YOU WAITING FOR? APPLY NOW!
RECRUITER: Kara Lloyd
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. If you are an individual with a disability and you require an accommodation in the application process, please email.
J2W: CLINICAL
MONJOBJ2WNECLIN
Ref:
SFSF: LS
Projektdetails
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Einsatzort:
East Hanover, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung