Sr. Analyst, Quality Assurance

Princeton, NJ, USA

Req #384

Tuesday, August 13, 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

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 Senior Analyst, Quality Assurance leads efforts in identifying policy development, ensuring appropriate archive and maintenance of files and data associated with Taiho drug development, and develops innovative ways to support initiatives across the quality assurance organization. The incumbent will be responsible for archive room and contracts with vendors for long-term file storage at both the Princeton, NJ and Pleasanton, CA offices. The incumbent must have a demonstrated proficiency in understanding and interpreting pharmaceutical regulations, work in collaboration with others and provide independent thought to improve processes for projects and operations with the ability to communicate effectively at all levels of the company.

Performance Objectives:

• Provide resources to development groups for consultation and interpretation of regulations/guidelines and corporate standards and policies related as related to archive needs.

• Collaborate with stakeholders in SOP preparation and maintenance within the business unit and harmonization of worldwide operating procedures, as applicable.

• Participate within the QA Dept to conduct internal and external audits.

• Collaborate and assist in activities to aid the QA Dept to accomplish company goals.

• Assist QA management in preparing process metrics and progress reports.

• Propose process improvements related to the QA function.

• Duties include copying, proof reading, filing and archiving company related documents.

• Manage both the onsite centralized records archive room and the use of a remote records center, including billing and contract needs.

• Interact with external vendors or contractors.

• Provide key input into the preparation, amendment, and harmonization of procedures.

• Propose to TOI management the perceived need for audits of TOI systems and processes.

• Address quality issues internally and with contracted vendors.

• Perform other duties based on department/company priorities.

• This position may require infrequent travel.

Education/Certification Requirements:

• BS/Master’s degree with at least 2 years related pharmaceutical/technical experience or a Bachelor’s degree with at least 5 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.

• Solid experience in quality assurance or in GxP archive management.

• Knowledge and experience in regulatory requirements for submission of documents in electronic format is a plus.

• 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.

• Strong interpersonal skills and the ability to positively influence and guide others.

• Effective organization, communication, and team orientation skills.

The pay range for this position at commencement of employment is expected to be between $106,250 and $125,000 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.

#LI-Hybrid

• Princeton, NJ, USA