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Group Leader Quality Assurance

8-10 years
Not Disclosed
10 Dec. 27, 2024
Job Description
Job Type: Full Time Education: MSc./M. Pharm/PhD 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: Clinical Quality Assurance Manager
Company: Teva Pharmaceuticals

Company Overview:
Teva Pharmaceuticals is a global leader in the generic medicines industry, on a mission to make healthcare affordable and accessible to millions worldwide. As the leading manufacturer of generic medicines, Teva proudly produces many products on the World Health Organization’s Essential Medicines List, impacting the lives of 200 million people every day. Teva’s diverse workforce spans across nearly 60 countries, united in the shared goal of improving global health.

Role Overview:
The Clinical Quality Assurance Manager will ensure the implementation and maintenance of the Quality Management System (QMS) for clinical operations, focusing on BA/BE studies. This role involves auditing clinical data, overseeing compliance with applicable Good Clinical Practices (GCP) and Good Laboratory Practices (GLP), and performing risk-based assessments for clinical and pathology laboratories. The position also entails supporting regulatory audits and ensuring the integrity of clinical study data and reports.

Key Responsibilities:

  • Quality System Oversight: Establish, implement, and maintain processes for the Quality Management System (QMS) at WPPL. Report performance to the Head of QA for review and continuous improvement.
  • Clinical Audits: Plan and execute clinical and system audits across all departments, ensuring compliance with GCP/GLP, protocols, and relevant SOPs.
  • Data Review: Review pharmacokinetic analysis, statistical data, and study reports, including the verification of SDTM data flow and clinical study reports.
  • Vendor Audits: Conduct external vendor audits to assess compliance and quality standards.
  • Regulatory Support: Provide support during regulatory inspections, review responses to regulatory queries, and manage CAPA actions based on investigation results.
  • Change Control: Review and evaluate the impact of change controls, deviations, and CAPAs.
  • Monitoring & Reporting: Conduct risk-based facility audits and monitoring of external CRO studies. Review and update policies, Quality Manual, and SOPs periodically.
  • Collaboration & Communication: Lead meetings with the clinical and pathology laboratory departments to discuss the quality system and its improvement. Collaborate with the WTI group to audit statistical data and clinical study reports.

Qualifications and Experience:

  • Education: M.Sc., M.Pharm., or Ph.D. in a relevant field.
  • Experience: 8-10 years of experience in Clinical Quality Assurance, particularly in BA/BE studies.
  • Skills and Knowledge:
    • Strong understanding of clinical study data, including pharmacokinetics, statistical analysis, and clinical study reporting.
    • In-depth knowledge of GCP/GLP guidelines and regulatory compliance.
    • Experience in conducting audits, reviewing change controls, deviations, and CAPA processes.
    • Ability to oversee external vendor audits and support regulatory inspections.

Personal Attributes:

  • Excellent communication skills, both verbal and written.
  • Strong analytical and problem-solving abilities.
  • Detail-oriented, responsible, and proactive.
  • Ability to work collaboratively with diverse teams.

Reports To:
Associate Director, Quality Function

Teva’s Equal Employment Opportunity Commitment:
Teva Pharmaceuticals is committed to equal opportunity in employment and fostering a diverse and inclusive workplace. We provide equal opportunities to all candidates without regard to race, age, gender, disability, or any other legally recognized status. We encourage individuals to inform us of any accommodations needed during the recruitment process to ensure an accessible candidate experience.

Join Teva in our mission to make a difference in healthcare!