Director, Quality Assurance PV

Director, Quality Assurance, Pharmacovigilance

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 : At Taiho Oncology, the compassion we practice for our patients extends to our team, empowering and motivating them to do their best work for those who need it most. This is an exciting opportunity to support and contribute to the continuous building of a unified Quality Assurance function in a dynamic, collaborative, and global cross-functional environment.

Position Summary

The Director, Quality Assurance, Pharmacovigilance (PV) reports into the Sr. Director, Quality Assurance, PV and is responsible for partnering with the Sr. Director of QA, PV and PV colleagues to assure their strategy and execution ingrains quality and compliance across all aspects of product safety across clinical development and post-marketing surveillance. Additionally, this position would represent QA to identify risks, resolve issues, and escalates appropriately to ensure the safe use of products globally.

This individual should demonstrate a high level of independent quality judgement and acumen and be able to work.

• Coordinate and assist in identifying policy development, promoting and assessing compliance of Taiho "customers" with regulations, guidelines, and operating procedures as applicable.
• Assist in global and local SOPs preparation and maintenance within the business unit and harmonization of worldwide operating procedures, as applicable. Liaise with Business Development and operations.
• Provide QA support end-to-end of PV activities, including case processing, safety surveillance, risk management, and signal detection and assessment.
• Identify possible compliance issues and review and approve Deviations, Corrective Actions and Preventive Actions (CAPAs).
• Responsible for supporting inspection readiness related to GVP.
• Support Taiho Global GXP operations.
• Review and contribute to Safety Data Exchange Agreements (SDEA's), Pharmacovigilance Agreements (PVA's), or other Contracts to ensure GVP compliance.
• Liaise with global regulatory agencies.
• Liaise with TOE and Taiho Pharmaceuticals Co., Japan, TCAN. TPOC, and TPAC as needed.
• Support inspection readiness activities including audits and inspections conducted by external sources as applicable.
• Author and maintain QA Standard Operating Procedures (SOPs) as necessary. Support management of other functional area SOPs.
• Perform QA review of PV deviations and trend analysis.
• Review of Pharmacovigilance Agreements or other applicable contracts for PV.
• Provide Quality Assurance leadership and Subject Matter Expertise (SME) for Good Pharmacovigilance Practices (GVP) to pharmacovigilance teams.
• Provide QA oversight of safety aspects of regulatory submissions, periodic safety reports (e.g., DSURs, PSURs, RMPs), and responses to regulatory inquiries.

Performance Objectives

Plan, conduct / coordinate GVP Audits, and / or consultancy projects, as necessary, according to Taiho Oncology, Inc., (TOI) and / or customer policies and procedures, within budget and agreed timelines. Demonstrated knowledge and thorough understanding of GVP in accordance with US / MHRA / EU / ROW Health Authority regulations, and industry standards such as ICH for the pharmaceutical industry. Excellent verbal, written, and presentation communication skills, ability to work with cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and advocating compliance. Strong understanding of clinical development, post-marketing safety, and regulatory submissions. 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. Audit of QMS against US, EU, national, and international regulation GVP. Audit of SOPs for Complaints and Adverse Event Reports in clinical and post-marketing. Represent Taiho at industry meetings, conferences, and seminars with presentations and training. Ability to deal with ambiguity and provide creative and pragmatic solutions to issues and risks. In-depth knowledge of global pharmacovigilance regulations and guidelines, including FDA, EMA, and ICH. Provide key input into the preparation, amendment and harmonization of procedures. Propose to TOI management the perceived need for audits of TOI's, TOE's and vendors' systems. Review and approval of Contract Manufacturing organization (CMO) / Contract Packaging Organization (CPO) Technical & Quality Agreements. Perform other related duties as assigned.

Education / Certification Requirements

Bachelor's degree, a Master's degree, or PharmD in a relevant field of study. Knowledge, Skills, and Abilities : 9 years of experience supporting QA and PV related activities within a global pharmaceutical company with Bachelors' degree in a relevant field of study. 6 years of experience supporting QA and PV with Masters or PharmD degree. Extensive knowledge of the pharmaceutical research and development process and the regulatory environment through which drugs receive and maintain their regulatory approval. Knowledge of EU and UK, Canadian markets preferred. Solid experience in quality assurance. Experience in computer systems and validation requirements. Working knowledge of TrackWise system is a plus. Demonstrated leadership skills. Project and regulatory management abilities. Excellence in written and oral communication. Ability to read, analyze and interpret scientific information and reports. Strong contract negotiation skills. 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. Travel according to audit schedules in an amount ranging from approximately 10-20%. Ability to read, analyze, and interpret scientific and technical journals and legal documents. 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 apply mathematical concepts to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions and deal with several abstract and concrete variables.

The pay range for this position at commencement of employment is expected to be between $198,050 - $233,000 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 annual bonus / incentive comp plans, potential long term incentive plan, 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 a candidate / 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.

Location : Princeton, NJ

Equal Opportunity Employer Information : Taiho Oncology is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law. Any applicant who, because of a disability, needs an accommodation or assistance in completing an application or at any time during the application process, please email People@taihooncology.com. Taiho Oncology also provides reasonable accommodations to employees with disabilities consistent with our obligations under the law. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment qualified applicants with arrest and conviction records. The incumbent in this position may be required to perform other duties, as assigned.

Job Family : Quality Assurance

Job Function :