Job description

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 experience multiple facets of Quality in a dynamic, collaborative and global cross-functional environment.
Position Summary
The Director, Quality Assurance leads and directs the activities involved for GXP audits, policy development, CAPA management and quality/compliance procedures.
Performance Objectives

• Plan, conduct/coordinate GXP audits (GXP = GCP/GLP/GMP), and/or consultancy projects, as necessary, according to Taiho Oncology, Inc., (TOI) and/or customer policies and procedures, within budget and agreed timelines.
• Coordinate and assist in identifying policy development, promoting and assessing compliance of Taiho "customers" with regulations, guidelines and operating procedures as applicable.
• Provide resources to development groups for consultation and interpretation of regulations/guidelines and corporate standards and policies related to GXPs, as applicable.
• Assist in SOP preparation and maintenance within the business unit and harmonization of worldwide operating procedures, as applicable. Liaise with Business Development and operations.
• Provide fundamental audit planning and audit management skills
• Liaise with Global Regulatory Agencies, and Taiho Pharmaceuticals Co., Japan.
• 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 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 and vendors' systems.
• Review and approve packaging design, packaging operations and labels for Investigational Medicinal Products (IMP.)
• Pre- and post- approval of batch records.
• Address with Contract Manufacturing/Contract Packaging Organizations (CMO/CPO) any sites quality issues
• Review and approval of deviations and complaints
• Review and approval of CMO/CPO Technical & Quality Agreements
• Participation in QP Declaration process
• Perform other related duties as assigned.

Education/Certification Requirements:

• BS/Master’s degree with at least 6-7 years related pharmaceutical/technical experience; or a Bachelor’s degree with at least nine years related pharmaceutical/technical experience, or equivalent experience.

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.
• Experience in Inspection Readiness Activities
• Experience in hosting or participating in Health Authority Inspections
• Solid experience in quality assurance and global health authorities.
• Experience in computer systems and validation requirements.
• Extensive experience in GMP activities, such as, review/approval of packaging, labeling, deviations, etc.
• 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.
• Ability to work in a global organization.

#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.
COVID-19: All new employees of Taiho Oncology are required to be fully vaccinated against COVID-19. Employees may request an exemption from this mandatory vaccination policy if the vaccine is medically contraindicated for them or medical necessity requires a delay in vaccination. Employees also may be legally entitled to a reasonable accommodation or exemption under applicable law if they cannot be vaccinated because of a disability, or if the provisions in this policy for vaccination conflict with a sincerely held religious belief, practice, or observance, or for other reasons protected by applicable law.
Requests for exemptions and reasonable accommodations must be initiated by notifying People@taihooncology.com that you will be requesting an exemption. All such requests will be handled in accordance with applicable laws and regulations.
The incumbent in this position may be required to perform other duties, as assigned.

Job Type: Full-time

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