Senior Manager Quality / Responsible Person (TPIG) (m/f/d) 100%

We Are Teva

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

Business Purpose

Responsible for quality oversight and regulatory compliance of processes and products within scope of activities for Teva Pharmaceuticals International GmbH (TPIG)

Responsible for quality approval and management of 3rd party suppliers/manufacturers

Roll out of Teva Quality Management System at business unit level

Ensure operational implementation of Quality Management System in compliance with GMP/GDP and Teva Corporate and Regional Standards

Report to Global Quality and local Management any critical quality incident with the corresponding corrective action plan

Primary company contact with local Health Authorities in relation to a.o. GMP/GDP inspections, quality incidents and recalls

Main Responsibilities

Rolling out of Teva Quality Management System

Create, maintain up-to-date and distribute Standard Operating Procedures and Working Instructions as per Teva standard and in compliance with national regulations

Ensure GMP/GDP compliance at the business unit and promote the quality culture

Lead GMP and GDP training at a local level

Initiate continuous improvement of processes

Attend to periodic quality councils

Provide quality metrics per defined frequency

Keep appropriate records of any delegated duties

Operational implementation of Quality Management System

Product trading - Ensure the distribution traceability of finished products and returns of products traded by the company

Distribution - Ensure the GDP compliance of the distribution centers

KPIs - Perform Management Review as per defined frequency

In case of recall ensure the local coordination between PhV, medical affairs, regulatory affairs, supply chain, etc. and with EU Qualified person concerned. Escalate any critical information to Global Quality and regional Commercial Quality and issue the final recall report, as applicable.

Change control, deviations and CAPAs - Administer, maintain and develop systems for change control, and deviation and CAPA handling

Suppliers/manufacturers and 3rd party service providers - Maintain, monitor and approve a list of approved suppliers. Ensure that Quality Agreements are set up and kept up to date with all suppliers/ manufacturers and 3rd party service providers as required

Supplier and customer authorization - Ensure that suppliers and customers are qualified. Maintain, monitor and approve a list of authorized suppliers and customers. Ensure that respective licenses and / or marketing authorizations are maintained

Release for sale batches (Finished Goods, APIs) which are manufactured and released by third party suppliers

Archiving - Ensure that relevant quality related documentation is archived as required

Authority inspections and audits - Host and lead GMP/GDP related competent authority inspections. Perform or coordinate internal audits of the compliance of the Quality System

Ensuring internal audits are performed at appropriate regular intervals following a prearranged program and necessary corrective actions are put in place

Perform or coordinate external audits, with respect to quality related matters, of local warehouses/distributors and other local suppliers/service providers as per Teva standards

Report critical quality incidents to Management - Report to Head of Quality and local management any critical quality incident per corporate standard

Internal and External Relations - Set up and maintain contacts with local general manager, local RA, drug safety officer, medical manager, launch manager, Quality personnel at the Teva and 3rd party manufacturing/batch release sites, local distributors and other relevant companies

Lead or support any quality or new trade projects as may arise from time to time

Your experience and qualifications

Education required

Master’s Degree in Pharmaceutical Sciences, Business, Healthcare or an equivalent combination of education and experience to the functional role

Experience required

Minimum of 2 years’ experience as a Quality Manager / QP / RP in a pharmaceutical company or importer / distributor

Specialized or Technical Knowledge Licenses, Certifications needed

Demonstrated knowledge and working experience with GMP / GDP and government regulations for Switzerland

In-depth knowledge of pharmaceutical industry as it relates to Quality Compliance. Working knowledge of pharmaceutical import and distribution operations

Other skills

Fluently in English and German

Ability to clearly communicate with all levels in the organization as well as Health Authorities

Leadership and managerial skills

Collaborate with other stakeholders in the organization

Proficient computer skills in current software including MS Officer

How We’ll Take Care of You

Competitive compensation package that reflects your skills and experience

Possibility to work in a dynamic environment in an impactful position

You would be a part of a high-performing team dedicated to success and innovation

Career growth opportunities by engaging in a role that offers significant responsibility and the chance to advance within the company

Function

Quality

Reports to

Dir SCQ Importation, Trading and Logistics

Contact

Maria Herzog

Human Resources

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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.