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

Daiichi Sankyo Europe GmbH; Uxbridge; On-site; GBP 65,000 - 85,000; Full time

Job summary

An established industry player seeks a Manager for Pharmacovigilance Quality Assurance in Europe. This pivotal role involves implementing quality assurance strategies, ensuring compliance with regulatory standards, and collaborating with diverse teams to enhance safety and quality management. The successful candidate will advocate for a culture of quality and continuous improvement, while also engaging in global activities as necessary. Join a forward-thinking organization that values innovation and compassion for patients, offering excellent benefits and a commitment to work-life balance.

Benefits

Excellent Benefits

Work-Life Balance

Growth and Development

Health and Wellbeing Support

Qualifications

• 5+ years in pharmaceutical or biotech Quality Assurance.
• Knowledge of PV regulations like FDA, EMA, and ICH.
• Experience in Clinical Safety and Pharmacovigilance.

Responsibilities

• Support planning and implementing QA strategy within CSPV.
• Provide proactive QA guidance for CSPV projects.
• Collaborate with cross-functional teams for compliance.

Skills

Pharmacovigilance Quality Assurance

Regulatory Compliance

Quality Management Systems

Analytical Skills

Problem-Solving Skills

Education

Bachelor’s degree in scientific or life sciences

Master’s or other advanced degree

Trained PV QA Auditor

Job description

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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 a highly qualified candidate to fill the position:

Manager, Pharmacovigilance Quality Assurance (PV QA), Europe (m/f/x) The Position:

The position will collaborate to support the implementation of the Quality Assurance strategy within the Clinical Safety and Pharmacovigilance (CSPV) function in Europe. Responsibilities include providing proactive QA guidance and support to projects and initiatives, consulting with management, ensuring communication with EU QPPV and other colleagues in CSPV, offering advice on issue investigation and solution implementation. The role collaborates with the Global Audits and Compliance group, Development and Medical Affairs QA, Quality Management Systems QA and GMP QA as needed. Additionally, the role involves supporting quality risk management activities, facilitating knowledge management, participating in inspections and audits, and collaborating with cross-functional teams to address safety and compliance concerns. This role is dedicated to activities in Europe, but may be assigned to support any global activities as deemed necessary.

The individual is expected to support proactive and strategic collaboration with CSPV, providing operational QA guidance and support with regulatory document execution/review, and advising on adherence to procedural documents and training programs. Continuous improvement of quality and compliance, interpretation of regulations and company standards, creation and review of relevant procedural documents, and cooperation with Daiichi Sankyo's Global Quality Assurance Organization are also part of the role. Lastly, the individual is responsible for advocating Daiichi Sankyo's Quality policy and culture.

Roles & Responsibilities

• Support planning and implementing the Quality Assurance strategy within the CSPV function, closely aligned with the business strategy and objectives, through effective communication and collaboration with the EU QPPV and other colleagues within CSPV, fostering a cohesive approach to quality management and ensuring compliance with regulatory requirements and the maintenance of robust quality management systems.
• Provide proactive QA guidance and support to CSPV projects and initiatives, ensuring comprehensive compliance oversight, closely aligned with the Regional Head of PV QA.
• Interact with other areas, such as Legal, Regulatory Affairs, Development and Medical Affairs QA, GMP QA and Quality Management Systems, as required.
• Offer consultation, advice, and support in the investigation and resolution of complex issues (e.g., Quality Deviations, Quality Events), overseeing the implementation of corrective and preventive actions, including Root Cause Analysis (RCA), and monitoring their progress to ensure timely closure.
• Collaborate with Global Audits and Compliance group (or equivalent) to support the execution of audit programs (e.g., affiliates, vendors), and oversee the monitoring of resulting findings and associated Corrective and Preventive Actions (CAPAs).
• Support risk management activities concerning the safety of Daiichi Sankyo’s products, including trend analysis of KQIs (e.g., findings, inspections, ICSR compliance, CAPAs) from a PV QA perspective, offering recommendations for continuous improvement.
• Support QA leadership in working groups and meetings, such as, but not limited to ones related to strategic alliances with business partners.
• Coordinate and support CSPV teams in adequately preparing for regulatory inspections and license partner audits, actively participating in the management of these inspections and audits.
• Facilitate knowledge management initiatives, sharing best practices and lessons learned from audits, inspections, regulatory intelligence, and process improvements to drive continuous improvement within CSPV operations.
• Collaborate with cross-functional teams, both locally and globally, to identify and address potential safety and compliance concerns.
• Collaborate proactively and strategically with other GxP Quality representatives, acting as the QA point person for all CSPV matters.
• Provide operational QA leadership and guidance to CSPV teams, ensuring compliance with regulatory requirements and the maintenance of robust quality management systems.
• Support the execution and/or review of key CSPV regulatory documents, Health Authority Commitments, agreements (e.g., Pharmacovigilance Agreements and Safety Data Exchange Agreements), QA-related sections of Pharmacovigilance System Master File (PSMF), and relevant incidents (e.g., Critical and major Quality Events or inspection/audit findings), ensuring compliance with regulatory and company requirements, and managing escalations and CAPAs as needed to ensure timely remediation of risks or issues.
• Provide advice and guidance to CSPV teams on adherence to procedural documents and training programs, facilitating staff competence and compliance.
• Foster continuous improvement initiatives, collaborating with stakeholders and QA line functions to identify and implement enhancements to quality and compliance practices.
• Recommend, create and review of relevant procedural documents, harmonizing local and global procedures, and addressing any gaps or inconsistencies.
• Propose, develop, review, deliver and monitor training for necessary stakeholders, ensuring awareness and understanding of quality and compliance requirements.
• Collaborate with Daiichi Sankyo’s Global Quality Organization to develop and maintain the local and global corporate quality management system, ensuring alignment with industry best practices and regulatory requirements.
• Champion Daiichi Sankyo’s Quality policy and Quality Culture, fostering a commitment to excellence and continuous improvement across CSPV functions.
• Travel globally, as required.
  
  
  

Qualifications

Education

• Bachelor’s degree in in scientific or life sciences, such as Pharmacy, or related discipline.
• Master’s or other advanced degree.
• Trained PV QA Auditor.
• Knowledge of national and international PV regulations and guidelines, such as FDA, EMA and ICH.
• Excellent knowledge of English.
  
  
  

Experience

• Minimum 5 years of experience in the area of pharmaceutical or biotech Quality Assurance.
• Experience in Pharmacovigilance Quality Assurance.
• Experience in Clinical Safety and Pharmacovigilance.
  
  
  

Competencies

• Analytic and systematic approach.
• Ability to understand complex matters and well-calculated risk taking.
• Highly reliable and accurate.
• Good interpersonal and negotiation skills.
• Good problem-solving skills, respect, and appreciation for cultural diversity.
• Team player, good communication skills and intercultural sensitivity.
  
  
  

Why work with us?

What we offer

• Excellent Benefits
• Work-Life-Balance
• Growth and Development
• Health and Wellbeing Support

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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