Instagram
youtube
Facebook

Qa Compliance Lead Auditor (Pv Quality Compliance)

3+ years
Not Disclosed
10 Nov. 15, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Senior Quality Assurance Auditor
Company: Fortrea

About Fortrea:

Fortrea, a global leader in contract research, supports pharmaceutical, biotechnology, and medical device industries with comprehensive clinical development, patient access, and technology solutions across 20+ therapeutic areas. Operating in over 90 countries, we drive innovation and uphold scientific rigor to bring new therapies to patients worldwide.

Role Overview:

Fortrea is seeking an experienced Senior Quality Assurance (QA) Auditor to lead quality initiatives, manage regulatory compliance, and support audit processes across global sites. This role includes creating QA policies, hosting inspections, and engaging with regulatory authorities to enhance QA standards.

Key Responsibilities:

  • Audit Leadership: Oversee audit activities, lead external audits, and host inspections, including regulatory and strategic client audits.
  • Policy Development: Develop global QA policies and provide expertise on complex regulatory topics.
  • Client & Authority Support: Act as a primary point of contact for niche regulatory matters, advising clients and internal teams.
  • Quality Metrics & Reporting: Lead quality reporting, monitor metrics, and implement corrective actions through various forums.
  • Process Improvement Initiatives: Spearhead quality initiatives to improve compliance and operational efficiency across global QA functions.
  • Team Support: Act as a backup for the QA Manager, providing monthly activity reports, and contributing to compliance and quality assurance projects as needed.

Qualifications:

  • Experience: Minimum of 8 years in regulatory or GxP roles, with lead auditor experience and a strong understanding of multiple regulations.
  • Education: Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field; postgraduate degree preferred (MSC or equivalent).
  • Skills: Proven leadership in process improvement, regulatory communication, and quality assurance.

Why Join Fortrea?

Be part of a global team committed to transforming clinical trials. At Fortrea, we foster professional growth in a collaborative, innovative environment where you can make a global impact on patient lives.

Equal Opportunity Employer:

Fortrea values diversity and inclusion. Employment decisions are based on qualifications and business needs, without discrimination on any legally protected characteristic. All qualified individuals are encouraged to apply.

Learn More and Apply: www.fortrea.com