Job Description
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 highly qualified candidates to fill the position of
Director, Global R&D Business Systems Compliance Lead (m/f/x)
The position:
In this role, the team member ensures that the business systems and operations managed by Global Development Information Management (G-DIM) are fully compliant and operating effec-tively to meet business needs. The role focuses on improving, aligning, and documenting pro-cesses and SOPs within and across systems, ensuring inspection readiness, managing risks, maintaining business continuity, coordinating health authority inspections for G-DIM, and en-suring that process and compliance artifacts are complete and current. The role partners closely with Quality Assurance (QA), Digital Transformation (DX), and business functions and is pivotal in aligning G-DIM business systems operations practices with global and industry standards, improving compliance, and leading system-related preparation for regulatory inspections and audits.
This role could be filled Europe-wide or in one of the Daiichi Sankyo office locations.
- G-DIM Process Development and Improvement: Conduct gap analyses and recommend new processes and improvements to ensure systems and operations quality and effective-ness, using Quality Assurance (QA) and Digital Transformation (DX) standards, and managing key risks. Ensure adherence to project, health authority audit, policy, procedures, and regula-tion standards related to systems and operations supported by G-DIM. Standardize and har-monize processes across systems and operations. Create business continuity plans for G-DIM managed systems and operations. Ensure G-DIM systems and operations have the appropri-ate SOPs, work instructions, and process documentation.
- G-DIM Inspection Readiness: Aim for a state of continuous inspection readiness by integrating quality into all G-DIM processes, systems, and operations. Drive compliance across G-DIM systems and operations to align with established frameworks and meet internal and external regulations, ensuring continuous inspection readiness. Conduct inspection readiness activities, assess guidelines, and support preparation workstreams. Review G-DIM processes, systems, and operations on periodic regular basis, and ensure timely remediations.
- G-DIM Compliance Management: Active member of Global SOP committee (GSOPC) which includes members of QA, DX, and R&D functions. Manage G-DIM responsibility concerning GSOPC deliverables. Ensure that the voice of G-DIM is heard by active participation in regular GSOPC meetings, sub teams, and QA interactions. Liaison on GSOPC topics of interest across G-DIM teams. Coordinate with QA and DX management to address remediation found during both internal and external audits in a timely fashion. Ensure a quality viewpoint built into Development system domains and projects. Ensure compliance with data privacy and GDPR regulations.
- G-DIM Audit Lead for Health Authority Audits: Point person for G-DIM for Health Authority Audits with system or operations impacts. Communicate with G-DIM leadership throughout the audit including daily status update. Ensure system access for Inspectors, coordinate G-DIM members to provide backroom support, and apply inspection preparation processes at time of audit. Collaborate with global team and business functions to manage deficiencies found, CAPA responses and follow up on necessary correction steps. Triage and manage outputs of Audits and CAPAs to bring in relevant G-DIM team members and drive resolution.
- G-DIM Process and Compliance Documentation: Document and manage process maps, SOPs, business continuity plans, and other compliance documents in an organized repository. Ensure all documentation is updated and retained according to schedules. Communicate with leadership about non-compliance and overdue items, and ensure that the process and document repositories are accurate and current.
- Bachelor's Degree required, Master's Degree preferred. IT, Engineering, or Life Sciences Related Field
- 10+ years total experience in one or more of the following areas: building quality view-point into systems operations processes, procedural document creation and maintenance, harmonizing processes across systems and operations
- Prior experience in Pharmaceutical Research & Development (sponsor or CRO) is required
- Business systems enhancement and operations background with responsibility for meeting compliance requirements
- Business process improvement experience (Lean Six Sigma, Kaizen, TQM, process mapping, and related tools)
- Experience in managing compliance processes and activities including inspection readiness, addressing inspection findings and CAPA management
- Global understanding of Data Privacy, including GDPR knowledge, and full under-standing of GxP validated environments based on various FDA standards 21 CFR Part 11 & relevant SOPs
- Global health authority system compliance knowledge, esp. US, EU, Japan, China
- Business continuity planning for business systems operations
- Familiarity with ICH E6 R3 guidelines
- Proficiency or knowledge in business systems and operations related to CTMS, TMF, Safety, IRT, Clinical Trials, Clinical Data Management, Precision Medicine, Records Management, Health Authority Inspection readiness related to Systems, SDLC, SOP creation, work procedures, and management
- Ability to travel up to 20% globally
- Excellent Benefits
- Work-Life Balance
- Growth and Developement
- Health and Wellbeing Support