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Qa Compliance Lead Auditor (Pv Quality Compliance)

2+ years
Not Disclosed
10 Sept. 25, 2024
Job Description
Job Type: Full Time 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 Overview:

As a leading global contract research organization (CRO), Fortrea is dedicated to scientific excellence, offering a comprehensive range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 employees in more than 90 countries, we are transforming drug and device development for partners and patients worldwide.

Essential Job Duties:

  • Conduct audits as specified in the audit activity table (note: this is a representative sample, not exhaustive).
  • Lead the development of global QA policies regarding the interpretation and application of regulations.
  • Provide subject matter expertise, offering guidance and support on niche regulatory topics to clients and authorities.
  • Host external audits and inspections, including regulatory inspections and those for strategic clients.
  • Facilitate and review responses to audit findings.
  • Report on quality metrics and implement corrective actions or process improvements through appropriate channels (e.g., Monthly Reports, Site Quality Reviews, Liaison meetings).
  • Manage or participate in global Quality initiatives aimed at enhancing compliance and efficiency within the QA organization.
  • Act as a backup for the QA Manager, providing monthly activity reports and performing other related duties as assigned.
  • Ensure adherence to Regulatory Compliance and Quality Assurance (RC&QA) responsibilities outlined in applicable controlled documents.
  • Perform additional duties as assigned by management.

Experience:

  • Minimum of 8 years in a regulatory environment, with experience in GxP roles.
  • In-depth knowledge of specific regulations and multiple regulatory frameworks.
  • Experienced Lead Auditor.
  • Proven ability to communicate strategically with clients.
  • Demonstrated experience in leading process improvement initiatives.

Qualifications:

  • Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related discipline.
  • A postgraduate degree (MSc or equivalent) in a science or management-related field is preferred.
  • Relevant experience may substitute for educational qualifications.

Join Us:

Fortrea is actively seeking motivated problem-solvers and creative thinkers who are passionate about overcoming barriers in clinical trials. We are committed to revolutionizing the development process, ensuring the swift delivery of life-changing therapies to patients in need. Join our exceptional team and embrace a collaborative work environment that fosters personal growth and meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Equal Opportunity Employer:

Fortrea is proud to be an Equal Opportunity Employer. We strive for diversity and inclusion within our workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are made based on business needs and individual qualifications, without regard to race, religion, color, national origin, gender (including pregnancy or medical conditions), family status, marital status, sexual orientation, gender identity, age, veteran status, disability, or any other legally protected characteristic. We encourage all qualified candidates to apply.