Director, Quality Assurance - Taiho Oncology

Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho’s success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It’s our work, our passion, and our legacy. We invite you to join us.  

Hybrid

Employee Value Proposition: 

New and exciting opportunity to join Taiho’s GCP Quality Assurance Team as a Director who will be responsible for leading quality initiatives across the Taiho clinical development portfolio, providing expert GCP regulatory guidance and advice to all development teams in support of Tiaho’s commitment to excellence in clinical trials and regulatory compliance. 

As an organization committed to executing well-controlled clinical trials and celebrating its achievements in operational excellence, Taiho is proud to lead by example in Quality and Regulatory Compliance. This Director, Quality Assurance, GCP role will lead and be responsible for managing GCP and QA activities across Clinical Development which includes leading GCP QA roles with all Clinical Trials Teams, the GCP Audit Program, regulatory inspection readiness, conduct GCP Audits, This role will be an integral part of the organization, and will ensure quality oversight of GCP service providers, Clinical Investigators, and related personnel and sites. This is a hands-on position with management responsibility of various projects across Taiho Clinical Programs.

Position Summary: 

• Lead, drive and represent functional and cross-functional projects focused on GCP Quality Assurance (eg, inspection readiness, conduct of audits or inspection readiness visits North America and EU regions).
• Lead QA collaboration with internal and external stakeholders not limited to GCP QA programs, policies, and procedures, project and study team representation.
• Primary business partner with internal organizations and Third-Party Vendors; serve as the subject matter expertise for vendor and investigator site audits, ensuring qualification of Third Party Vendors, adequacy of CAPAs to ensure overall compliance
• Ensure overall quality compliance with health authority regulations and guidelines, providing guidance and expertise to all clinical team leadership.
• Presentation skills necessary, with ability to generate written procedures and to deliver GCP training, when needed.
• Provide resources to development groups for consultation and Interpretation of global regulations/guidelines and corporate standards and policies related to GCPs, as applicable.
• Assist in global and local SOPs preparation and maintenance within the business unit and harmonization of worldwide operating procedures, as applicable.
• Ability to escalate and manage critical issues, seek resolution and collaborate with the Taiho Teams when possible compliance issues have been identified and manage Corrective Actions and Preventive Actions (CAPAs).
• Lead Taiho Global GCP initiatives and partnership with Taiho Pharmaceuticals GCP teams.
• Liaise with global Regulatory Agencies (inspectors), as needed.

Performance Objectives: 

• Lead GCP Quality Assurance function at Project and Study Teams.
• Subject matter expertise for vendor and investigator site audits, ensuring qualification of Third Party Vendors, adequacy of CAPAs to ensure overall compliance.
• Provide GCP guidance and expertise to all clinical team leadership.
• Present GCP updates to study teams weekly.
• Review of critical clinical trial documentation and documents submitted to regulatory agencies, ability to provide analysis and feedback to teams about the requirements and best practices; lead GCP advisory role.
• Lead and conduct audits at Clinical Trial Sites and Contract Research Organizations.
• Provide interpretation of global regulations/guidelines and corporate standards and policies related to GCPs, as applicable.
• Escalate and manage critical issues when brought to attention, seek resolution and collaborate with the Taiho Teams to resolve and present, manage Corrective Actions and Preventive Actions (CAPAs).
• Lead partnership and collaboration efforts with GCP teams at Taiho Pharmaceuticals Co., Japan.
• Subject Matter Expert for GCP audits
• Liaise with Global Regulatory Agencies (Mainly, Inspectors during a regulatory inspection setting),
• Ability to plan, schedule, prepare for, conduct audits, report, CAPA management and close out all audits undertaken. Review/approval of validation documentation as per 21 CFR, Part 11.
• Interface with senior management regarding quality/ compliance issues, as necessary.
• Represent Taiho at industry meetings, conferences, and seminars with presentations and training.
• Provide key input into the preparation, amendment and harmonization of procedures.
• Provide TOI Quality Operations Team recommendations for vendor or site audits, as needed and based risk concerns. Address with GCP Vendors or CRO any quality issues
• Ability to conduct any level of PAI GCP Inspection Readiness; experience with Regulatory Inspections required; solid understanding of how to prepare teams going into a global regulatory submission. Creation, review or approval of GCP deviations
• Review of CRO Quality Agreements
• Perform other related duties as assigned.

Education/Certification Requirements: 

• BS/Master’s degree with at least 10 years related GCP Quality Assurance expertise

Knowledge, Skills, and Abilities: 

• Minimum experience: min.10 yrs in a direct GCP Quality Assurance role in the pharmaceutical or biotech industry.
• Direct experience in providing GCP QA expertise in Oncology Clinical Trials
• Experience with Health Authority Regulatory Inspections (GCP BIMO- EU, US, Health Canada)
• Experience preparing teams, vendors, and clinical sites for inspections.
• Extensive knowledge of EU and UK GCP Requirements (eg, EU CTR, MHRA Requirements)
• Solid experience in GCP Quality assurance (e.g, previously conducted inspection readiness, successful inspection outcome and experience with health authority inspections, can easily conduct audits of clinical sites and CROs as needed etc,).
• Experience in computer systems and validation requirements. 
• Working knowledge of QA systems is a plus. Demonstrated leadership skills.
• Project and regulatory management abilities.
• Ability to perform GCP activities with minimal guidance; use of good judgement and ability to provide advice on demand to teams in need of GCP interpretation,
• Excellence in written and oral communication
• Ability to read, analyze and interpret scientific information and reports.
• Sound judgment and reasoning skills to define problems and collect and analyze data.
• Strong interpersonal skills and the ability to positively influence and guide others.
• Excellent problem-solving, risk analysis and negotiation skills.
• Effective organization, communication, and team orientation skills.
• Significant telephone, electronic, and face-to-face communications.
• Willingness to conduct GCP Audits or attend GCP QA Meetings with up to 25% travel required.  US bi-coastal travel will be necessary in GCP Quality Assurance role.
• Ability to respond to inquiries or complaints from regulatory agencies.
• Ability to write procedures.
• Ability to effectively present information to internal and external clients.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• The incumbent in this position may be required to perform other duties, as assigned.

The pay range for this position at commencement of employment is expected to be between $185,000 and $218,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, commissions, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. 

If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. 

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