• Full Time (Salaried)
  • Remote,

Company:  Confidential

Job Title: Sr. Manager/Assoc. Dir., GXP Quality

Job Number: 34834

Location: Remote, 

Job Description

An exciting new opportunity is available for a Senior Manager/Associate Director in GXP Quality (GCP/GLP/GVP). Responsibilities include ensuring quality and compliance of development programs per regulatory standards and supporting GLP studies. Reporting to the Director, Quality & Compliance.

Responsibilities

  • Provide GCP/GLP/GVP QA oversight and support to stakeholders.
  • Assist in developing the annual audit schedule.
  • Conduct audits as per schedule, including clinical sites, CROs/vendors, processes, systems, projects, and documents to ensure compliance.
  • Track and communicate deviation and audit trends.
  • Investigate and resolve quality issues.
  • Collaborate with QA counterparts at CROs/vendors.
  • Prepare for and host regulatory inspections.
  • Conduct QA reviews of protocols, consent forms, reports, and validation plans.
  • Perform additional responsibilities as needed.

Required Skills

  • Bachelor’s Degree in a scientific field; advanced degree preferred.
  • 7-10 years in pharmaceuticals with 5 years in GCP QA.
  • Strong grasp of GCP, GLP, and GVP regulations.
  • Familiarity with US and international clinical trials.
  • Willingness to travel domestically and internationally about 25% of the time.
  • Proficient in reviewing clinical documents with excellent communication skills.
  • Organized, independent worker with collaborative problem-solving abilities.

 

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