Manager, PV QA Europe (m/f/x)

Select how often (in days) to receive an alert:

Manager, PV QA Europe (m/f/x)

Date: 7 May 2025

Location: All Europe, Europe, UB8 1DH

Passion for Innovation. Compassion for Patients.

Daiichi Sankyo, with over 120 years of experience and more than 17,000 employees across over 20 countries, is committed to discovering and delivering innovative healthcare solutions that improve lives worldwide.

In Europe, our focus areas include protecting against cardiovascular disease and advancing oncology treatments, aiming to become a leading global pharmaceutical innovator.

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

We seek a highly qualified candidate for the position of:

Manager, Pharmacovigilance Quality Assurance (PVQA), Europe (m/f/x)

The Position:

This role involves supporting the implementation of the Quality Assurance strategy within the Clinical Safety and Pharmacovigilance (CSPV) team in Europe. Responsibilities include providing QA guidance, consulting with management, ensuring effective communication with the EU QPPV, and supporting audits and inspections. The role collaborates with global QA groups and involves supporting quality risk management, knowledge sharing, and compliance activities. It may also support global initiatives as needed.

The individual will provide strategic QA guidance, oversee compliance with regulations and company standards, and promote a culture of quality within Daiichi Sankyo.

Key responsibilities include supporting QA strategy implementation, providing operational guidance, managing investigations and CAPAs, supporting audits, and collaborating with cross-functional teams to ensure safety and compliance.

The role requires active participation in inspections and audits, facilitating knowledge exchange, and supporting continuous improvement initiatives. It also involves developing and delivering training, maintaining quality systems, and ensuring adherence to regulatory and internal standards.

The candidate must be willing to travel globally as required.

Qualifications:

Education

Bachelor’s degree in pharmacy, life sciences, or related field; Master’s or higher degree preferred. Training as a PV QA Auditor is required. Knowledge of PV regulations (FDA, EMA, ICH) is essential. Proficiency in English is required.

Experience

• At least 5 years in pharmaceutical or biotech Quality Assurance.
• Experience specifically in Pharmacovigilance Quality Assurance.
• Experience in Clinical Safety and Pharmacovigilance.

Additional skills include analytical thinking, reliability, strong interpersonal and negotiation skills, problem-solving, cultural sensitivity, and effective communication. The ability to understand complex issues and manage risks is essential.

#J-18808-Ljbffr