Purpose of the function

LOCATION: Munich, Germany

Responsibility for providing quality oversight of the research laboratory in Daiichi Sankyo Europe (Munich, Germany) and conduct end-to-end audit activities per audit program of nonclinical/GLP/GCLP relevant audit activities. Ensures the execution of a risk-based audit program and effective CAPA management resulting from audits, health authority inspections; manages audit planning, assignments, support, and reporting of audits/inspections across the organization and affiliates as appropriate for the audits assigned. Provide quality consultation to business functions to ensure laboratory and data integrity and compliance.

Roles and Responsibilities

• Provide quality oversight of the research laboratory to ensure laboratory operations, data integrity, and compliance are being addressed and managed appropriately.
• Serve as a QA representation at cross-functional meetings whereby GCLP/GLP/research activities are being discussed.
• Responsible for engaging directly with Health authorities to address compliance relevant matters and lead any remediation efforts.
• Support the development of GLP/GCLP systems, risk management processes such as SOPs for QA activities for internal and external oversight.
• Manage and conduct the QA review of GLP/GCLP and research study protocols, clinical study reports, external publications, and regulatory authority submissions.
• Provide quality oversight of vendors that are responsible for biomarkers, special analytical methods, assays etc., are assessed and that any nonconformance are appropriately mitigated.
• Conduct end-to-end audit activities per audit program of nonclinical/GCLP relevant audit activities.
• Develop and manage metrics for reporting purposes at senior leadership meetings.
• Review, define, develop SOPs, instructions, manuals, inspection readiness strategy for GLP/ research unit for global activities.
• Ensure regulated activities related to computerized systems are in place and that all regulations being adhered to.
• Identify QA compliance issues pertinent to GLP/GCLP activities, implementing solutions and partnering with stakeholders to ensure a compliant ready state of operation.
• Collaborate with QMS Team and applicable QA function to ensure no overdue CAPAs.

Education & Experience

• Bachelor's Degree in a scientific, health care or related discipline required.Experience
• 5 or more years of professional experience in Quality within the pharmaceutical/CRO industry, with involvement in regulated clinical laboratories
• Auditing experience in GLP/clinical laboratory, especially biomarker laboratory.
• Proficiency in GLP/GCLP, ICH GCP Guidelines, US and European regulatory requirements for regulated laboratories.
• Ability to provide interpretation and guidance for internal and external customers on GxP related regulations / guidelines (e.g., EU, ICH) and company procedures and policies.
• Professional or other related functions and familiarity with Oncology, Specialty Medicines and Companion Diagnostic products
• Experience in clinical biomarker laboratory, and/or companion diagnostic laboratory.
• Proven experience with Health Authority Inspections, (e.g., European regulatory agencies)
• International experience is a plus; but at minimum, experience working with diverse cultures and employees
• User knowledge of Trackwise, Veeva or similar software

Skills and additional Requirements

• Ability to work collaboratively with cross-functional stakeholders to drive process improvements
• Ability to write comprehensive audit reports and 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
• User knowledge in MS Office 365• Fluent in German and English