VP, Quality Assurance GMP
Location
Princeton, NJ | United States
Job description
VP, Quality Assurance GMP
Princeton, NJ, USA Req #343
Wednesday, February 28, 2024
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 Position Summary: Reporting to the Senior Vice President, Quality, the Vice President, Quality-GMP is responsible for developing and managing the global strategy for GMP Quality Management Systems. This role will lead quality initiatives from clinical trial material release through fully commercialized compounds. The VP, Quality-GMP will ensure inspection readiness and will be a liaison to Health Authority representatives in the US, Canada, and Europe with GMP and Pharmacovigilance Quality oversight. Leading a team of 10 professionals, this individual will ensure Taiho Oncology maintains a comprehensive Quality Management System (QMS) and Vendor Management in accordance with regulations and guidelines. The chosen candidate will be a highly experienced and innovative quality leader with strong experience in late-stage development and commercialization.
Performance Objectives: - Provides guidance and direction in the development and maintenance of QMS that is GMP compliant with the various health authorities where Taiho Oncology has or will commercialize products.
- Develop and manage GMP best practices for system maintenance, documentation, and processes.
- Lead inspections and audits with health authorities and contract manufacturing partners.
- Provide strategy and direction to contract manufacturing partners with a constant eye to ensuring the partners are fulfilling Taiho Oncology's expectations.
- Provide global Quality GMP training. The VP, Quality-GMP will develop and administer a training curriculum for the quality organization and other relevant stakeholders as required.
- Provide global strategy and oversight for pharmacovigilance management and compliance.
- Provide quality data that appropriately assesses risks, opportunities, and potential exposure for the company. Effectively share/present data to enable business leaders to make fact-based decisions.
- Lead the GMP quality organization with a constant emphasis on talent management and creating a culture that allows Taiho Oncology to attract and retain the best quality talent possible.
- Coordinate quality initiatives with relevant stakeholders in other functions. The chosen candidate will have a passion for continuous improvement and will be driven to harmonize and align activities across sites and regions.
- Stay current on all changes and requirements in each market where Taiho Oncology conducts business. The VP, Quality GMP will be a credible subject matter expert to both internal and external stakeholders.
- Manage and monitor global GMP non-conformance and CAPA.
Education/Certification Requirements: - Advanced degree in life sciences, health related, or pharmaceutical field is preferred.
- 10+ years of biopharmaceutical quality assurance experience, including at least three years of hands-on experience leading GMP quality.
Knowledge, Skills, and Abilities: - Strong understanding of pharmacovigilance with the ability to ensure effective monitoring and reporting tools and processes are in place.
- Demonstrated ability to navigate complex international regulatory requirements and build positive relationships with global regulatory authorities.
- GMP and Pharmacovigilance quality experience with clinical trial materials through commercial launch and production.
- Taiho Oncology has four guiding principles: PACT. People (patients and employees) first, Accountability (for your own and for Taiho's success), Collaboration (fostering open communication), and Trust (honesty and integrity in every behavior). The chosen candidate will embrace and demonstrate those traits in everything they do.
- Superior communication skills with a track record of managing third-party CMO and/or CRO partners.
- Strong analytical skills with a proven ability to assess risks and present multiple viable solutions when necessary.
- Lead from the front style. The chosen leader will enjoy teaching and mentoring staff and will help make training and development a strength of the organization.
- Experience in late-stage and commercial stage companies. A track record of international product launches is ideal.
The pay range for this position at commencement of employment is expected to be between $267,750- $315,000 annually; 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, 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 PTO, 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.
#LI-Hybrid
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
[email protected] . 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.
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