Job Title: Manager, Quality Function
Location: Mumbai, India
Company: Teva Pharmaceuticals
Job ID: 58500
Date Posted: November 24, 2024
About Teva
Teva Pharmaceuticals is the world’s largest generic medicines producer, striving to make good health more accessible and affordable. Operating across 60 countries, Teva touches the lives of 200 million people every day by delivering essential and innovative medicines. Join Teva to be part of a mission-driven team making a global impact.
The Opportunity
As a Manager, Quality Function within Teva's External Manufacturing and Supply Operations (EMSO), you will ensure quality compliance of EMSO's systems, focusing on contract manufacturing sites in the APAC region. You will support the Quality Management System (QMS) for EMSO while ensuring regulatory compliance and timely resolutions to the Supplier Relationship Team (SRT) and Contract Manufacturing Organizations (CMOs).
Key Responsibilities
External/Contract Manufacturing Oversight:
Ensure quality compliance for contract manufacturing sites.
Oversee sterility assurance and contamination control strategies, including risk assessments.
Coordinate with internal EMSO teams and other regions to address business and escalation needs.
Quality System Management:
Maintain and implement QMS SOPs for EMSO APAC and ensure adherence.
Monitor Key Performance Indicators (KPIs) and ensure timely resolution of QMS elements.
Review and approve complaint investigations and change controls.
Sterility Assurance & CCS:
Ensure sterility assurance plans are in place at contract sites.
Review and approve contamination risk assessments and mitigation strategies.
Collaboration:
Coordinate cross-functionally to ensure compliance and address escalations effectively.
Continuous Improvement:
Drive improvements in quality systems and ensure no overdue elements in QMS.
Address and escalate critical quality issues to management.
Your Qualifications
Education:
B. Pharm, M. Pharm, M.Sc. (Science), or B.Sc. Sciences.
Experience:
10–15 years in the pharmaceutical industry, with sterile manufacturing experience.
Expertise in operational quality, QA/QC, and external/contract manufacturing sites.
Proven knowledge of sterility assurance, contamination control, and pharmaceutical compliance.
Knowledge and Skills:
In-depth understanding of cGMP, QMS, and compliance standards for regulated markets (e.g., USFDA, EU).
Experience with manufacturing and analytical investigations.
Strong verbal and written communication skills.
Negotiation and influencing skills to meet organizational objectives.
Reports To
Associate Director, Quality Assurance
Teva’s Commitment to Equal Opportunity
Teva Pharmaceuticals is committed to fostering a diverse and inclusive workplace. Employment opportunities are provided without regard to age, race, religion, gender, disability, or any legally recognized status entitled to protection under applicable laws. Accommodations are available for candidates throughout the recruitment process.
This is your opportunity to lead quality compliance efforts and make a difference in the pharmaceutical landscape! Apply today to join Teva on its mission to improve global health.
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