Senior Manager PV Audits - Audits and Compliance (m/f/x)

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.

Role and responsibilities:

• 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

Professional experience and Education:

• 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 sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Why work with us?

Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.

For more information: www.daiichi-sankyo.eu