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Manager Quality Function

10-15 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: External Manufacturing Quality Oversight Lead
Company: Teva Pharmaceuticals

Company Overview:
Teva Pharmaceuticals is committed to making health more affordable and accessible globally. As a leading manufacturer of generic medicines, Teva produces many of the products on the World Health Organization’s Essential Medicines List. Today, more than 200 million people worldwide rely on Teva’s medicines every day. The company is always looking for new ways to make a difference and welcomes new people to join this mission.

Role Overview:
The External Manufacturing Quality Oversight Lead will be part of Teva’s External Manufacturing and Supply Operations (EMSO) team. This role is crucial for ensuring that external and contract manufacturing sites comply with both regulatory requirements and Teva's internal quality management standards. The jobholder will provide oversight of quality systems for contract manufacturing sites in the APAC region and manage the relationship with external suppliers and CMOs (Contract Manufacturing Organizations).

The jobholder will also be responsible for managing quality systems related to deviations, complaints, and change controls, as well as ensuring that Key Performance Indicators (KPIs) related to quality metrics are met. This includes managing sterility assurance and contamination control strategies at contract manufacturing sites and coordinating with internal teams and external stakeholders to address escalations and meet business requirements.

Key Responsibilities:

  • External/Contract Manufacturing: Oversee quality compliance at contract manufacturing sites and ensure that quality standards are being maintained.
  • Quality Management System (QMS) Oversight: Ensure the QMS for EMSO APAC is compliant with Teva’s quality standards and regulatory requirements. This includes implementation and maintenance of relevant Standard Operating Procedures (SOPs).
  • Sterility Assurance/Contamination Control Strategy (CCS): Review and approve sterility assurance and contamination control strategies at contract manufacturing sites, including risk assessments.
  • CFT Coordination: Coordinate internally within EMSO and with other regional teams to address business needs and resolve escalations.
  • KPI Metrics and QMS Management: Ensure that KPIs for EMSO quality are met and that there are no overdue elements in the QMS system.
  • Complaint and Change Control Management: Review and approve complaint investigations and change control processes.
  • Continuous Improvement: Drive improvements in quality systems and processes.

Qualifications and Experience:

  • Education: B. Pharm, M. Pharm, M.Sc. (Science), or B.Sc. in Sciences.
  • Experience: Minimum 10-15 years of experience in the pharmaceutical industry, particularly with sterile manufacturing.
  • Skills and Knowledge:
    • Extensive experience with operational quality, QA/QC, and external/contract manufacturing sites.
    • Expertise in sterility assurance and contamination control strategies.
    • Deep knowledge of cGMP, quality management systems, and pharmaceutical manufacturing and supply chain operations.
    • Familiarity with compliance standards and regulations (e.g., USFDA, EU) for pharmaceutical manufacturing.
    • Experience in handling manufacturing and analytical investigations.
    • Strong verbal and written communication skills.
    • Excellent negotiation and influencing skills to ensure alignment with Teva’s expectations.

Reports To:
Associate Director, Quality Assurance

Teva’s Equal Employment Opportunity Commitment:
Teva Pharmaceuticals is an equal opportunity employer. It is committed to providing employment opportunities without discrimination based on age, race, gender, disability, or other legally recognized statuses. Teva values diversity and inclusion and supports all employees through accessible recruitment and selection processes.

Apply now to be a part of Teva’s global mission to improve health worldwide through innovative and compliant external manufacturing quality oversight!