Sr. Manager, Quality Assurance Operations (Information Technology)

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: 

Due to the highly regulated and confidential nature of Quality Assurance, this position requires a positive and experienced professional with a focus on high quality detailed work, initiative, sound judgment, and work ownership. The incumbent is responsible for training and document management across TOI and affiliates. Leading by influence, the individual must be well organized and have excellent oral and written communication skills to effectively interact with internal and external parties to ensure quality needs are met in a timely manner.  Responsible for the day-to-day oversight of the (Learning Management System) LMS.

Performance Objectives:

Training coordinator/ Document coordinator Activities:

• Partners with TOI functional departments and TOI direct Affiliates ensuring training deliverables, creates training courses, assigns training, manages job codes, manages users and user's account in LMS as needed.
• Generates system reports from LMS, provides technical support to resolve process/ Training & Document Management system related concerns as needed.
• Tracks and reports metrics associated with training and document compliance.
• Creates/updates documents in training area as needed.
• Launches controlled documents in LMS for review as needed.
• Performs controlled document admin activities, reviews document, sets document effective date, and launches training on controlled documents for all company employees.

Additional Responsibilities:

• Participates in UAT testing of Quality System owned by Quality Assurance group.
• Acts as a QA representative to review/approve Computer System Assurance (CSA) documents as needed.
• Conducts classroom trainings for New Hires and Document Creator Revisor Course.
• Propose process improvements related to the QA function.
• Maintains and updates policies and procedures related to LMS.

Education/Certification Requirements: 

• BA or BS degree required with at least eight years related pharmaceutical/technical quality assurance or regulatory documentation experience, or equivalent experience.

 

Knowledge, Skills, and Abilities:

• Considerable experience in a pharmaceutical industry working in a regulatory or quality assurance department.
• Solid knowledge and experience on QA/QC processes.
• Experience with Master Control and/or TrackWise system is a plus.
• Highly developed organizational skills and attention to detail are mandatory.
• Project and regulatory management abilities.
• Excellence in written and oral communication.
• Sound judgment and reasoning skills to define problems, collect and analyze data.
• Strong interpersonal skills and the ability to positively influence and guide others.
• Effective organization, communication, and team orientation skills.
• Adaptable, able to cope and manage changing priorities.
• Capable or working with minimal supervision, after general guidance.
• Ability to read and write English.
• Ability to write procedures. 
• Ability to effectively present information to internal and external clients.
• 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.
• Highly proficient in Microsoft office.

The pay range for this position at commencement of employment is expected to be $156,400 - $184,000 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