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Job Details

Reg. Affairs – CQA - Senior Manager & GCP Auditor

Company: RBW Consulting
Location: Central New Jersey
Reference: RAA-SMRACQAA-CNJ
Closing Date: 11 Jan 18
Type: Full Time
Salary (£): 100,000+
Benefits: Competitive Benefits Package

Job Summary:

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at 617 982 1238 today!

Requirements:

Reg. Affairs – CQA - Senior Manager & GCP Auditor

Central New Jersey

RESPONSIBILITIES

  • Audit clinical trials including clinical investigator site audits, clinical vendor audits, directed audits, and other special audits and assessments to assess quality level and compliance with applicable GCP regulations in support of company clinical programs.
  • Create formal audit reports and identify critical audit findings to senior management, including recommendations for corrective action and/or regulatory reporting, if necessary.
  • Serve as QA representative on active clinical/development projects.
  • Provide guidance and recommendations to the Clinical Operations department,
  • Serve as resource for interpretation and evaluation of GCP compliance issues for Clinical Development, Quality Assurance, and Regulatory Affairs.
  • Conduct internal audits.
  • Coordinate PAI readiness activities.
  • Conduct due diligence audits/activities. 
  • Review and approve audit responses.
  • Ensure effective closure, by working with “auditees” to ensure comprehension, development and execution of corrective/preventive action with regard to any non-conformity cited during audits.
  • Assist in preparing the audit schedule for the year.
  • Assist in the management of the clinical audit program, including oversight of contract auditors as needed.
  • Develop/modify audit checklists as regulatory requirements change.
  • Conduct and support benchmarking activities.
  • Lead development of process improvement strategies and tools related to GCP compliance efforts.
  • Maintain required knowledge of applicable regulations and government, industry and company GCP standards and their interpretations by participating in industry trainings, workshops and discussion groups.
  • Support the development and delivery of GCP training programs.
  • Support of other QA projects as needed.

MINIMUM JOB REQUIREMENTS

  • BA/BS in the life sciences required.
  • At least 5 years of relevant pharmaceutical industry experience, including at least 4 years of GCP audit experience.
  • Thorough knowledge of ICH Guidelines and GCPs including regulatory requirements for the conduct of clinical development programs.
  • Familiarity with GLP and database audit practices a plus.
  • Excellent oral, written and verbal communication skills.
  • Appropriate technical skills in GCP compliance.
  • Proven interpersonal skills.
  • Ability to travel – 60% max.
  • International travel is required.

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at 617 982 1238 today!

Apply for this job: Reg. Affairs – CQA - Senior Manager & GCP Auditor

Contact Information:

Address:  US Team
210 Broadway #201, Cambridge, Massachusetts,
02139
USA
Tel:  (617) 982 1238
Website:  Visit Our Web Site

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