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Sr. Analyst, Quality Assurance

3 months ago

Princeton, United States TAIHO ONCOLOGY INC Full time

Sr. Analyst, Quality Assurance

Princeton, NJ, USA

Req #377

Tuesday, June 18, 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. Taihos 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. Its 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 will be responsible for managing and inputting vendor and audit data into TOIs Supplier Quality Management (SQM) system, supporting coordination and execution of audits, supporting computer system validation processes, and supporting vendor management and audit initiatives. This role requires a keen eye for accuracy, strong organizational skills, and a thorough understanding of compliance standards in the industry.

Performance Objectives:

  • Collect, organize, and maintain all vendor and audit-related data and documentation.

  • Input audit findings, observations, and recommendations into TOIs SQM system.

  • Ensure the accuracy and completeness of audit records and reports.

  • Support internal and external audits of processes, procedures, and systems to assess compliance with regulatory requirements and internal policies.

  • Support the development of audit plans, schedules, and checklists with internal business partners to guide the audit process.

  • Identify areas of non-compliance and provide recommendations for corrective actions.

  • Support computer system validation activities, including documentation review, testing, and validation protocols.

  • Collaborate with IT to ensure that computer systems meet regulatory requirements and quality standards.

  • Ensure validation documentation and records are maintained in accordance with established procedures.

  • Assist in the evaluation and selection of vendors based on compliance criteria and quality standards.

  • Monitor vendor performance and adherence to contractual obligations.

  • Provide vendor metrics as requested by quality team for QMSR or other management reviews

  • Coordinate audits of vendors to assess compliance with regulatory requirements and contractual agreements.

  • Stay current with industry regulations, guidelines, and best practices related to audit data management, compliance, and vendor management.

  • Support the development and implementation of compliance policies, procedures, and training programs.

  • Address quality issues internally and with contracted vendors.

  • Perform other duties based on department/company priorities.


Education/Certification Requirements:

  • Bachelors 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 activities.

  • Proven experience in audit data management, compliance, or related roles within regulated industries (e.g., pharmaceuticals, healthcare, etc.).

  • Strong knowledge of regulatory requirements, such as FDA regulations, GxP guidelines, etc.

  • Experience with audit methodologies, tools, and techniques.

  • Familiarity with CSV and CSA processes and documentation.

  • Ability to read, analyze and interpret scientific information and reports.

  • Excellent communication skills, both verbal and written.

  • Strong analytical and problem-solving abilities.

  • Ability to work independently and collaborate effectively with cross-functional teams.

  • Attention to detail and a commitment to accuracy and quality.

  • Experience with TrackWise, a popular quality management software, would be an asset for the candidate applying for this role.


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

  • Princeton, NJ, USA