Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology, Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
SUMMARY
- Develop the strategic direction for Global Research QA including activities under GLP,GCLP. Translational research Oncology, precision medicine and other research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to exercise influence at the senior leadership and/ or executive level wherever GLP/non-GLP/ research programs impacting Oncology and / or specialty medicines are being discussed. Develop a QA structure that could support GLP/non-GLP/ GCLP Research activities at the global level. Support through open and effective communication and business partnering the cross-functional implementation of the Vision and Mission of Global QA. Drive a Culture of solution oriented and evidence-based mind-set with openness for innovative ways of working with new technologies/ Implementing strategic and tactical plans to drive sustainable improvements.
- Supports Regulatory Affairs in providing quality content and review of documents supporting GLP/non-GLP/ Research submissions to Health authorities globally. Provide QA oversight of GLP/GCLP activities of Daiichi Sankyo, contract research organization/ vendors ensuring that outsourced obligations are in compliant and prepared for regulatory submissions and / or inspections Ensures that appropriate systems, processes are in place to enhance GLP/GCLP activities being executed at DS cross-functional teams (i.e.., Research, Translational Oncology, GDO etc.,).
- Serve as a QA representation at key governance meetings whereby GCLP/GLP activities are being discussed (Regulatory affairs, Research unit LT, GRDC etc.,) Effectively interacts with broad range of colleagues in order to establish a globally aligned GCLP/GLP strategy across DS teams. Establishes and / or develops operational resource strategy to determine the extent of resources needed to deliver on GLP/GCLP commitments that are pivotal to early phase submissions.
- Collaborate with Global QMS to build a phase appropriate quality system that supports quality and compliance of Good Clinical Laboratory Practices and Good Laboratory Practices. Proactively identifies compliance risks impacting research unit across DSG, and assures that mitigation strategies are in place.
- Responsible to engage directly with Health authorities such as FDA, EMA, Swiss medic, and other local authorities as necessary to address compliance relevant matters and lead any remediation efforts.
Responsibilities
- Leads nonclinical QA function to implement a quality system in accordance with 21CFR part 58 (Good Laboratory Practice (GLP), and other global regulatory authority requirements, and industry best practices.
- Ensure /support the development of GLP/GCLP systems, risk management processes such as SOPs for QA activities for internal and external oversight.
- Manage and/ or guide the QA review and approval of GLP and GCLP study protocols, clinical study reports, ICFs, external publications, and regulatory authority submissions (IMPD/IND) Responsible to design the audit framework globally for Research area, specifically GLP/GCLP studies.
- Partners with Audit and Compliance QA function to develop compliance and risk criteria, in order to assure compliance with regulations, standards and guidance such as ISO, CLIA, etc.
- Ensures that laboratories and / or vendors that are responsible for biomarkers, special analytical methods, assays etc., are assessed and that any nonconformance are appropriately mitigated.
- Ensure approved metrics are in place to monitor and provide proper QA oversight of research area, in close collaboration with stakeholders. Ensure metrics for reporting purposes are readily available for presenting at senior leadership meetings.
- Ensure and lead the establishment of the Quality Systems for the Research Quality area, and that all components of QMS are in place for adequate quality review and oversight.
- Develop and implement the Research Quality QRB with key partners and collaborators.
- Review, define, develop SOPs, instructions, manuals, inspection readiness strategy for GLP/ research unit for global activities and regulators.
- Ensure a process is in place for routine review of regulatory documents such as IB, protocol, CSRs, IND and NDA
- Ensure GLP regulated activities for computer systems are in place and in some areas ensure that an internal QA assessment of research notebooks for compliance oversight is in place and all regulations being adhered to.
- Ensure that Clinical Development activities (i.e.., protocols) are aligned with GLP/GCLP, FDA, ICH, EMA, PMDA regulations/ standards and guidance.
- Identify QA compliance issues pertinent to GLP/GCLP activities, implementing solutions and partnering with stakeholders to ensure a compliant ready state of operation.
- Ensure that CRO/ Vendor quality events/ incidences are adequately reviewed and CAPAs followed up and / or closed as appropriate. Serve as a key contributor on several leadership teams and governance committees to provide quality overview, metrics, trends, impacting the Business portfolio: a. Research Committee/ CDx/Translational Oncology/Precision Medicine/ RD-DLTb. External Alliance Committee. b. Quality leadership team c. Develop/ chair or co-lead quality council as necessary.
- Ensure the vision is in place to build the talent pipeline(recruitment) and ensure succession plans are in place and promote the values of integrity, accountability, transparency necessary to drive change in fast pace, changing organization.
- Allocates and manages financial and human resources within the function.
- Accountable for performance, progress and success of the team by ensuring that objectives are clear, in place and that teams are managed to drive results.
QUALIFICATIONS
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
- Must have a Bachelor's Degree Bachelor's degree in Life Sciences, Pharmacy or Medicines
- PhD or other post graduate degree strongly preferred
Experience Qualifications
- Must have at least 10+ years of professional expertise within GxP regulated activities, and QA leadership positions; broad understanding of global expectations of Health Authorities in the GxP area; profound understanding of the science of product development.
- Must have experience within a global pharmaceutical company with expertise in: oncology, biologics or vaccines.
- Must have proven expertise within Quality Assurance Research to support Global Research QA including activities under GLP, GCLP. Translational research Oncology, precision medicine and other research relevant duties under the RDPV QA function
- Must have proven ability to lead and influence others within a global/matrix environment in the pharmaceutical industry required
- Must have proven people management experience including experience in a matrix, global environment required
- Must have strong communications skills, written and oral.
Travel
Must have the ability to travel up to 20%. Domestic and International travel
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.