: Inicio > Oferta de trabajo en Suiza > biólogo/bióloga > Audit Manager - Pharmacovigilance, Compliance (m/f/d) (biologe/biologin)

en Español in English auf Deutsch en Français ...

Audit Manager - Pharmacovigilance, Compliance (m/f/d) (Biologe/Biologin)

Oferta de empleo de biólogo/bióloga en Suiza (Zürich)

Clasificación del trabajo: Profesionales científicos e intelectuales › Profesionales de las ciencias y de la ingeniería › Profesionales en ciencias biológicas › Biólogos, botánicos, zoólogos y afines › biólogo/bióloga.

Traducción de la profesión: Akademische Berufe › Naturwissenschaftler, Mathematiker und Ingenieure › Biowissenschaftler › Biologen, Botaniker, Zoologen und verwandte Berufe.

Descripción de la oferta de trabajo:


Passion for Innovation. Compassion for Patients.

With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.

Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.

We are seeking qualified candidates to fill the position of

Senior Manager PV Audits -

Audits and Compliance (m/f/x)

The position:

The Senior Manager, GvP Audits is responsible to support all aspects of pharmacovigilance audits and regulatory inspections including preparation, conduct, tracking and verification of CAPA commitment implementation to assure all are in an acceptable state of compliance. The position will report to the Head of Global Audits and Compliance.

Plan, schedule, conduct and report Pharmacovigilance audits including Service Providers, systems and processes, license partners and affiliates to assure that all are in an acceptable state of compliance

Document audit conduct, findings, CAPA ensuring supporting documentation, tracking / verification of CAPA commitment implementation are conducted within the electronic quality management systems in a timely manner

Support all aspects of pharmacovigilance regulatory inspections including preparation, conduct, coordinating responses, evaluating supporting documentation, tracking and verification of CAPA commitment implementation, and effectiveness checks

Escalate critical findings from audits and inspection to QA and functional department leadership

Support management of Quality Assurance SOPs and policies to ensure that they are current, adhere to laws, regulations, guidance documents and Daiichi-Sankyo standards

Support quality documentation and quality system implementation programs

Liaise and consult with CSPV and others to ensure local and global conformance with regulatory requirements, GvP, internal standards, and to provide proactive integration of quality and process improvement

Bachelor's Degree in a scientific, health care or related discipline and/or background in Medical health Profession (RN, Medical technologist, etc.) required

7 or more years Quality Assurance experience with a world class quality organization in the Pharmaceutical/CRO industry

7 or more years First-hand knowledge of GVP Compliance Professional or other related function and familiarity with Oncology, Specialty Medicines and Companion Diagnostic products

7 or more years Experience of direct dealings with Health Authorities, (e.g., FDA, HPFB, MHRA and other European regulatory agencies)

7 or more years International experience is a plus; but at minimum, experiences working with diverse cultures and employees

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to gender, gender identity, romantic orientation, ethnicity, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Excellent Benefits


Growth and Development

Health and Wellbeing Support

País del trabajo: Suiza.

Región: Zürich.

Ver 764 ofertas de trabajo en "Zürich" (Suiza).

Número de puestos: 1.

Empleador: Daiichi Sankyo Europe GmbH.

Instrucciones para solicitar:

Gewünschte Bewerbungsarten: über Internet Internetadresse: Stellenangebot-Details in der Jobsuche der BA aufrufen: 14225-212857_05a7482-S

Oferta de trabajo obtenida del portal Eures, con fecha 05 de Mayo de 2024, y con identificador de la vacante:14225-212857_05a7482-S.

Ver las 38 ofertas de trabajo de Profesionales científicos e intelectuales › Profesionales de las ciencias y de la ingeniería › Profesionales en ciencias biológicas › Biólogos, botánicos, zoólogos y afines › biólogo/bióloga ofertadas.

Ofertas de trabajo similares: