Manager, R&D Quality Professional Date: Jan 15, 2025 Location: Zagreb, Croatia, 10000 Company: Teva Pharmaceuticals Job Id: 60155 **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. **How you’ll spend your day** + Supporting activities within the R&D, Zagreb and external Teva partners, to ensure that current Good Manufacturing Practices, Teva Global Policies and Standards and relevant Regulatory Authority requirements are met + Understanding of Teva pharmaceutical development process (including the QMS), and contributing to Quality related decisions that affect product development + Reviewing and approving all documentation generated in support of new products and processes to ensure compliance with regulatory requirements + Ensuring all OOS results and unplanned deviations with respect to R&D are fully investigated and documented and any corrective and preventative actions identified are implemented + Evaluating changes related to development processes + Providing Quality review of CMC regulatory submissions when required + Reviewing R&D QA systems and processes to ensure best practice, using continuous improvement to suggest system improvements + Assessing current and developing regulations and regulatory position in order to develop and implement changes within the business to ensure continued compliance + Participating in inspections for new product approvals (i.e. Pre-Approval Inspections, Bioequivalence inspections) **Your experience and qualifications** Qualifications: + Minimum degree in Pharmacy, Science, Engineering or similar + Minimum of 3 years in a Quality Assurance/ Analytical control/ other related experience in manufacturing or R&D environment within the pharmaceutical industry + Experienced in sterile operations to EU and FDA standards is desirable + Experienced with Regulatory inspections (either hosting or being a key presenter) is desirable Knowledge: + Understanding of quality procedures related to Pharmaceutical Development + Significant knowledge of ICH, ISO, US, and EU guidelines and their implementation for CMC product development + Understanding of GMP requirements in relation to product manufacture and packaging + Knowledge of the drug manufacturing process and analytical methods and knowledge of product development is a plus + Knowledge of root cause analysis and Risk management + Deep understanding of Quality Management Systems + Experience auditing development CMC activities is a plus + Trained in cGMP requirements + Experience with combination products is desirable Skills: + Well-developed communication skills with the ability to persuade and influence all levels of colleagues, regulators and industry specialists + Hold the highest standards of integrity, especially in decision making and the application of standards + Ability to objectively review a wide range of technical data and feedback problems and concerns in a constructive manner + Ability to present information to and influence + Proven ability to manage priorities to consistently deliver on time against tight timelines + High level of problem-solving skills, able to use a range of structured tools to complement background knowledge + Proficiency in MS Office, SAP and Track Wise®, EDMS + Excellent in written and spoken English **Already Working @TEVA?** If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte\_company=1080030P) The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner. **Teva’s Equal Employment Opportunity Commitment** 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. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. EOE including disability/veteran