Sr. Director, Quality Assurance

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 Senior Director of Quality Assurance, Pharmacovigilance (PV) is responsible for partnering with the Leader of Pharmacovigilance to assure their strategy and execution ingrains quality and compliance across all aspects of product safety across clinical development and post-marketing surveillance. This role is instrumental in applying a risk-based approach to ensure that PV activities align with regulatory requirements and company standards. Additionally, this position would represent QA to identify risks, resolve issues, and escalates appropriately to ensure the safe use of products globally. This leader should demonstrate a high level of independent quality judgement and acumen.

In partnership with the Pharmacovigilance (PV) colleagues, drive strategy and execution of the following:

• Establish and maintain a compliant QA oversight program for PV data and ensure compliance with reporting standards and company policies.
• Perform periodic regulatory intelligence on new Health Authority policies and industry standards that impact PV. Understand and implement changes to maintain compliance.
• Provide Quality Assurance leadership and Subject Matter Expertise (SME) for Good Pharmacovigilance Practices (GVP) to pharmacovigilance teams.
• Provide QA oversight for end-to-end PV activities, including case processing, safety surveillance, risk management, and signal detection and assessment.
• Drive a risk-based approach to PV activities, with appropriate metrics and trending.
• Responsible for inspection readiness related to GVP.
• Provide QA oversight of safety aspects of regulatory submissions, periodic safety reports (e.g., DSURs, PSURs, RMPs), and responses to regulatory inquiries.
• Ensure risk management/reduction strategies are developed and included in relevant documents such as clinical study protocols.
• 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.
• Lead process improvement projects as needed.

Scope of Oversight Responsibilities:

Provide Quality oversight for PV related documents, such as not limited to the following:

• Local Individual Case Safety Reports (ICSR)
• Local Product Safety Master File (L-PSMF)
• Risk Management Plan and implementation of additional Risk Minimization Measure
• Local Periodic Safety Update Report (PSUR)/Aggregate Report Management
• Product Labeling Changes
• Regulatory Authority Communication
• Pharmacovigilance Training
• Pharmacovigilance Business Continuity Plan (BCP)
• Signal Management and Benefit Risk Assessment
• Urgent Safety Alert support
• Pharmacovigilance Audit and Inspection
• Compliance monitoring and metrics
• Pharmacovigilance data archiving
• Corrective and Preventive Action (CAPA)
• Liaise with global Regulatory Agencies.
• Liaise with TOE and Taiho Pharmaceuticals Co., Japan.

Performance Objectives:

• Demonstrated ability to provide QA oversight of Serious Adverse Event (SAE) processing and ensure timely, compliant, and accurate safety reporting in accordance with applicable regulatory requirements, Good Clinical Practice (GCP), and standard operating procedures (SOP).
• Possesses expert knowledge of current ICH and health authority requirements, expectations, and trends in patient safety and pharmacovigilance, and ensure compliance in all activities. Ensure readiness for health authority inspections and partner audits.
• 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.
• 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.
• Ability to use expertise and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways.
• 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.
• Strong understanding of clinical development, post-marketing safety, and regulatory submissions.
• Experience interacting with global regulatory authorities and scientific advisory bodies.
• Exceptional leadership, strategic thinking, and communication skills.
• 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.
• Liaise with Global Regulatory Agencies.
• 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.
• Interface with senior management and trans-national 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.
• Propose to TOI management the perceived need for audits of TOI's, TOE’s and vendors' systems.
• Review and approval of deviations and complaints  
• Perform other related duties as assigned.

Education/Certification Requirements: 

• Bachelor’s degree in a relevant field of study with at least 12 years of experience supporting QA and PV related activities within a global pharmaceutical company; or a Master’s degree with at least 6 years of experience supporting QA and PV.
• Experience in EU and UK PV requirements required

Knowledge, Skills, and Abilities:

• 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 markets required.
• Solid experience in quality assurance.
• Experience in computer systems and validation requirements.
• Working knowledge of IXRS systems is a plus.
• Demonstrated leadership skills.
• Project and regulatory management abilities.
• Ability to read, analyze and interpret scientific information and technical journals and legal documents.
• 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.
• 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 $229,500-$270,000 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. 

#Location-Princeton,NJ #LI-Hybrid