Manager Quality Assurance

at  Teva Pharmaceuticals

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Manager Quality Assurance
Date: Feb 3, 2025
Location:Bucharest, Romania, 011171
Company: Teva Pharmaceuticals
Job Id: 60602

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.

EDUCATION

• Required – Chemistry, Biology, Pharmacy. QP certification is required
• Preferred - Master or equivalent degree in Chemistry, Biology or Pharmacy

KEY REQUIREMENTS

• Minimum of 5 years pharmaceutical manufacturing site quality operations and leadership experience, including:
  o Deep knowledge of cGMP requirements of local and major international authorities like EMA and US FDA for products and process,
  o Deep knowledge on sterile dosage forms manufacturing and sterility assurance
  o High level of understanding of manufacturing, packaging, ICH guidelines as well as CMC content of regulatory submissions,
  o Knowledge of chemical/pharmaceutical production operations/ lifecycle, production equipment/ validation and relevant technologies and product types,

  o Deep knowledge of Quality Systems

• Experience leading, inspiring and coaching teams

• Experience developing and implementing and continuously improve existing and new, efficient, and effective business processes
• Must have adequate practical knowledge of pharmaceuticals manufacturing and/ or control
• Must have practical knowledge of pharmaceutical cross functional operations (e.g., Supply Chain, Engineering, Production)

The candidate should be able to delegate, well organized, should be able to adapt and lead change.

• Leads the QA organization on site - Quality Compliance, Quality Systems, QP and Quality Assurance.
• Ensure a current Quality Management System is in place and continuously improved
• Ensure products are manufactured, released and distributed in accordance with cGMP requirements and registered specifications.
• Assess and Mitigate Risks- Identify quality risks and define proactive mitigations, to ensure the products are safe and effective before they reach the market. Work with the business to assure compliant and reliable supply
• Promote a Sustainable Culture of Quality-Create, develop and maintain a culture of enhancing quality throughout the entire site operation. Create a space where people can speak openly and are encouraged to present new ideas to improve quality
• Maintain strong partnership with Operation, Supply Chain, Engineering, MS&T
• Provide effective Quality leadership during internal, customer and Health Authority inspections
• Ensure that Quality KPIs are meeting pre-defined targets, ensures CAPA commitments are implemented in a timely manner and its effectiveness is monitored periodically