Strategic Development Operations Lead

4 days ago

San Francisco, California, United States Daiichi Sankyo, Inc. Full time

Director, Process Innovation and Compliance

Dedicated to advancing innovative pharmaceutical therapies

The Daiichi Sankyo Group has consistently pushed the boundaries of scientific expertise for over 125 years. With a presence in more than 20 countries and a robust pipeline of promising new medicines, we strive to improve standards of care and address diversified, unmet medical needs globally.

Our vision is to become a Global Pharma Innovator with Competitive Advantage in Oncology by 2025, focusing primarily on novel therapies in oncology as well as other research areas centered around rare diseases and immune disorders.

Job Summary:

The Director, Process Innovation and Compliance will provide strategic direction, planning, coordination, and implementation of process improvement initiatives to ensure regulatory compliance and cross-functional cohesiveness across processes and related documents.

This role involves overseeing the development and maintenance of an overview of processes and associated document landscape, including planned updates, changes, and retirements. The ideal candidate will create awareness of process updates resulting from organizational changes, regulatory requirements, CAPAs, cross-functional initiatives, and routine process updates.

Key Responsibilities:

  • Process Landscape Development: Develop and maintain an overview of process landscapes, including planned new documents, changes, and retirements. Create awareness of process updates due to organizational changes, regulatory requirements, CAPAs, cross-functional initiatives, and routine process updates.
  • SOP Authorship and Review: Maintain a close working relationship with Quality Assurance and participate in the Company Global SOP Committee. Provide reviews of draft SOPs/changes from a cross-functional process point of view and offer guidance to authors to ensure regulatory compliance, consistency, and connectiveness across SOPs.
  • Process Improvement: Recommend and implement innovative process ideas and tools to expedite process authorship, review, and approval timelines. Develop reporting/dashboards to communicate process development and revision status and expected effectiveness timelines.
  • Training and Effectiveness: Work with leaders, process authors, and change enablement teams to coordinate process training and effectiveness beyond basic training.
  • Inspection Readiness: Provide support for audits, inspections, and inspection readiness activities as needed.

Qualifications:

The successful candidate will have a Bachelor's Degree with a minimum of 10 years' experience in pharmaceutical or biotechnology development functions or clinical quality assurance. They will also possess knowledge and understanding of GCPs and applicable global regulatory guidelines governing clinical trials.

We are looking for individuals with strong project management skills, experience leading projects/teams, and the ability to influence others without direct authority. Effective and influential communication, self-management, complex problem-solving, critical thinking, and organizational skills, including navigating through ambiguity, are essential.

Travel: Ability to travel up to 5%

Daiichi Sankyo, Inc. is an equal opportunity employer committed to diversity and inclusion. 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.

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