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Associate Director, Quality Auditor (All Genders) - Part-Time Possible

3-5 years
Not Disclosed
10 Dec. 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Job Title: Pharmacovigilance Quality Auditor

Location: Europe or USA (with global travel opportunities)
Department: Healthcare


About Us:

At [Company Name], we are united by our mission to improve and extend lives through innovation in Healthcare, Life Sciences, and Electronics. With a strong focus on therapeutic areas such as Oncology, Neurology, and Fertility, our teams work passionately across six continents to transform healthcare and make a lasting impact on patients' lives. Joining us means becoming part of a diverse and inclusive culture where personal development and global career advancement are at the forefront.


Your Role:

We are looking for motivated, self-starting individuals to join our Quality Auditing team in the pharmacovigilance area. In this role, you will have the opportunity to lead, coordinate, and participate in various types of quality audits globally, ensuring the highest standards of compliance and quality. You will engage with stakeholders across Research & Development and contribute to maintaining and improving quality standards in line with international and local Pharmacovigilance regulations.

Key responsibilities include:

  • Audit Planning & Execution: Lead and participate in the planning and execution of pharmacovigilance audits (subsidiary/affiliate audits, vendor audits, process audits, and business partner audits) both on-site and remotely.
  • Data Analytics & Reporting: Conduct data analytics during the audit preparation phase, prepare meaningful and standardized audit plans, create detailed audit reports, and follow up on audit observations.
  • Continuous Improvement: Lead special projects to improve the quality auditing function, ensuring audits are conducted with consistent high quality.
  • Inspection Management Support: Support the Inspection Management Team in preparing for inspections and managing follow-up actions post-inspection.

Who You Are:

  • Qualifications & Experience:

    • Minimum of 3-5 years auditing experience in pharmacovigilance quality management and/or systems.
    • Comprehensive understanding of Quality Assurance principles and auditing skills, with a focus on pharmacovigilance (and ideally additional GxP areas).
  • Technical Knowledge:

    • Strong working knowledge of GVP, ICH, US FDA, and EMA regulations and guidelines.
    • Experience with PowerBI, MS Office 365, and Veeva Vault QMS.
  • Skills & Abilities:

    • Excellent organizational and project management skills, with a proven ability to meet milestones under tight deadlines.
    • Strong communication and interpersonal skills, with the ability to interact respectfully with auditees and stakeholders.
    • Ability to work independently and demonstrate a motivated, responsible approach.
  • Language Proficiency:

    • Excellent oral and written communication skills in English (additional language skills, such as Chinese or Spanish, are preferred).
  • Other:

    • Willingness to travel globally (up to 15% travel).

What We Offer:

We are a team of curious minds from diverse backgrounds, bringing unique perspectives and life experiences to our work. We believe that diversity drives excellence and innovation, enabling us to lead in science and technology. Join us to work in a culture of inclusion and belonging that empowers you to grow at your own pace while contributing to the mission of improving human health.


Apply now and be part of our global team that is working to make a meaningful difference in healthcare!