Manager (m/f/x) Audits & Compliance (GVP)

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Manager (m/f/x) Audits & Compliance (GVP)

Location: All Europe, Europe, 81379

Passion for Innovation. Compassion for Patients.

With over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, 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 are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.

Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada.

We are seeking a highly qualified candidate to fill the position:

Manager (m/f/x) Audits & Compliance (GVP)

The Position

Responsibility for end-to-end audit activities per audit program of GVP relevant audit activities for Daiichi Sankyo\’s Audits & Compliance group and its partners including Pharmacovigilance (PV) processes & systems, affiliates, external service providers (“vendors”) and license partners as applicable.

Ensures the execution of a risk-based audit program and effective CAPA management resulting from audits, health authority inspections, non-compliance and incidence or deviations.

Together with regional management teams plans, supports, conducts and reports (PV) audits/inspections across the organization and affiliates as appropriate for the area of GVP audits assigned.

Roles and Responsibilities

Pharmacovigilance Audits

• Implement and maintain the Global pharmacovigilance risk-based strategy for audit and risk assessment activities
• Manage, perform / collaborate in the completion of the GVP audit universe risk assessment and selection of PV processes and entities for the annual global GVP Master Audit Schedule.
• Manage and coordinate the audit program for (PV) processes & systems, affiliates, vendors, license partners as applicable for GVP audits assigned in alignment with the Master Audit Schedule. Using a risk-based approach to ensure the Strategic and Tactical Audit Plans are aligned with the company’s strategy and objectives and adjust the plan as needed to support business functions, internal and external stakeholders to execute audits effectively.
• Manage audits and contract auditors (where applicable) in-line with the global GVP Master Audit Schedule, Daiichi Sankyo’s business model and applicable procedures.
• Ensure the GVP auditing program is compliant with regulatory requirements, performs audits, identifies compliance issues and trends, reviews systems and procedures.
• Support reporting of quality metrics for audits and inspections and execute against these metrics consistently.
• Ensure up to date audit CAPA information in the eQMS in a timely manner. Provide compliance oversight metrics and trend analysis of Quality Status to global QA management and to stakeholders of internal and external functions.
• Collaborate with QMS Team and applicable QA function to ensure no overdue CAPAs.

Daiich i Sankyo Quality System

• Support the GVP and/or other QA teams in identifying and defining quality improvement initiatives for the Daiichi Sankyo Quality System.
• Ensure continuous improvement and enhancement of the Quality System by supporting global metrics generation and ‘lessons learned’ from GVP audits and inspections.
• Support inspection readiness by preparing Clinical Safety and Pharmacovigilance (CSPV) and post marketing stakeholders for key Health Authority GVP inspections; provide inspection management support and follow-up activities post inspection regarding compliance commitments are fulfilled on time and that evidence is archived.
• Manage the data collection and review of EU/UK PSMF Quality core sections and annexes applicable to GVP audits.

Personal Skills and Professional Experience:

• Bachelor\’s Degree in a scientific, health care or related discipline required. Experience Qualifications
• 8 or more years of professional experience in Quality and clinical development in the Pharmaceutical industry, with involvement in regulated clinical trials, clinical safety, pharmacovigilance
• Proficiency in ICH Guidelines, US and European regulatory requirements relevant to pharmacovigilance. Ability to provide interpretation and guidance for internal and external customers on GVP related regulations / guidelines (e.g., FDA, EU, ICH) and company procedures and policies.
• For GVP, proficiency in GVP Modules and regulatory requirements for pharmacovigilance and post-marketing safety
• Professional or other related function and familiarity with Oncology, Specialty Medicines and Companion Diagnostic products
• Exposure to and awareness of relevant regulations and guidance documents in the area of Good Clinical Practices, Regulatory Affairs, Clinical Development would be advantageous
• Proven experience with Health Authority Inspections, (e.g., FDA, HPFB, MHRA and other European regulatory agencies)
• International experience is a plus; but at minimum, experience working with diverse cultures and employees
• Expertise working within early development through Phase III and Pharmacovigilance studies preferred

Skills and additional Requirements

• Experience working both independently and as part of a global multifunctional team
• Ability to review comprehensive audit reports and write summary documentation for senior management and functional areas
• Proven organizational skills and strong ability to prioritize workload
• Detail oriented and commitment to seeing tasks through to completion
• Ability to handle high workloads, stressful situations, and deadlines

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