Vendor Management Analyst III

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

The Vendor Management Analyst III position is filled by a professional who possesses the compliance and Regulatory knowledge and skills necessary to provide direction and guidance in current Good Manufacturing Practice (cGMP) regulations for vendor management activities related to clinical and commercial biopharmaceutical manufacturing. The incumbent works to assure the quality, accuracy, and integrity of data in manufacturing operations, and regulatory submissions and to assure that effective and appropriate Quality Management Systems are in place and followed. The incumbent applies experience and excellent communication skills within a collaborative environment to assure that the GMP Quality culture are embraced by the site to enable a commitment to continuous quality improvement and embrace a permanent inspection ready attitude.

The position involves advanced knowledge of the Quality Management System (QMS) and its implementation in relation to the ICH Q7, ICH Q10 and 21 CFR 11/211, Annex 11 requirements at the site.

Essential Responsibilities:

• Perform paper audits in support of vendor selection and qualification activities.
• Perform on-site audits of vendors in support of vendor approval.
• Draft and manage the lifecycle of Quality Technical Agreements in support of vendor approval.
• Monitor, review and approve Supplier Change Notifications.
• Assist in the continued development and maintenance of the supplier management program.
• Utilize Quality Systems to review and approve change controls, deviations, CAPAs and CAPA Effectiveness checks.
• Assist in the preparation of Site Quality Council.
• Assist in the development, management, and improvement of the Quality Management System (QMS) to ensure compliance with applicable regulations and company procedures, in support of GMP commercial and clinical manufacturing, and bioanalysis activities.
• Author and/or Support gap assessments of local SOPs to corporate standards.
• Update local SOPs, forms and work instructions as applicable.
• Support general QMS activities and initiatives.
• Support GMP compliance and inspection readiness initiatives.
• Support regulatory agency filings and inspections.
• Ensure activities are performed/completed using current Good Manufacturing Practices

Additional Compliance Responsibilities

• Use of Microsoft Word, Excel, and PowerPoint to support compliance team activities.
• Serve as Quality resource, representing QA on teams in support of assignments.
• Support cross functional department customers in a manner which is clear in approach, communication and action.
• Assist in the planning and execution of Internal Audits.

Your experience and qualifications

• BS/BA or Undergraduate degree in applicable discipline, preferably life science.
• Minimum 5 years of experience in Quality Assurance working with vendor management; including audits and QTAs.
• Advanced knowledge in quality compliance (cGMP, ICH, FDA, EMA, USP/EP policies & guidelines) required

Enjoy a more rewarding choice

Make a difference with Teva Pharmaceuticals

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Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

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