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Biotech & Pharma Clinical Trials Quality Assurance Manager (previous GCP exp. mandatory)

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Basic Job Info

 
Location
US-MD-Bethesda
 
Experience Required
5 to 12 years
 
Degree Required
4 Year Degree
 
Begin Date
2/6/2019
 
End Date
3/5/2019
 
Base Pay
N/A
 
Employment Type
Full-Time
 
Manages Others
True
 
Travel Required
Up to 25%
 
Relocation Covered
False

Job Description

RESPONSIBILITIES 

  • Plan and lead GCP audits (international and domestic), including clinical investigator sites, contract clinical laboratories, and CROs to determine compliance status and identify compliance risks.
  • Assess GCP compliance risk areas and develop and implement risk mitigation measures.
  • Ensure compliance with company’s procedures and regulatory requirements.
  • Conduct QA reviews of project-related Clinical Development essential documents (e.g. protocols, amendments, case report forms, tables and listings, informed consents, investigator brochures, and Clinical Study Reports).
  • Review and provide input in to non-clinical documentation (e.g. protocols, study reports).
  • Facilitate GCP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies.
  • Participate in the evaluation and selection of “CROs and other clinical and nonclinical service providers.
  • Provide guidance, interpretation and information on GCP regulations, standards and quality systems.
  • Develop and implement standards, policies and procedures for GCP regulatory compliance.
  • Develop and measure quality metrics to drive consistent quality standards relating to GCP activities.
  • INTERNATIONAL TRAVEL REQUIRED (up to 25%).

Job Requirements

REQUIREMENTS

  • Master’s Degree preferred with minimal 10 years’ experience in Biotech or Pharma and 5+ years’ experience in Quality Systems related to GCP.
  • Strong analytic skills with practical knowledge of how to identify key performance quality metrics to set targets for maintaining a state of compliance while identifying areas for improvement.
  • Extensive experience auditing clinical CRO’s, clinical sites and investigator sites.
  • Understanding of domestic and international regulatory requirements.
  • Outstanding communication skills (interpersonal, verbal and written).
  • Proven track record of industry success.
  • Strong leadership and management skills.

 

Technical Resources International is fully committed to Equal Employment Opportunity and to attracting, retaining, developing and promoting the most qualified employees without regard to their race, gender, color, religion, national origin, age, physical or mental disability, veteran status, or any other characteristic prohibited by state or local law.

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