Manager, Quality Assurance

US-NJ-Princeton
Category
Quality Assurance
Type
Regular Full-Time

Position Summary

Taiho Oncology, Inc. works urgently to discover and develop innovative cancer treatments. As cancer evolves, we evolve with it—bringing novel technology to cornerstone chemotherapies, while at the same time optimizing new targeted agents. Advanced technology, dedicated investigators, and incomparable facilities—these vast resources empower us to redefine the way the world treats cancer. It's our work; it's our passion; it's our legacy. 

 

We currently have an opening for a Manager, Quality Assurance.  This position will coordinate and assist in identifying policy development, promoting and assessing compliance of Taiho Oncology, Inc., (TOI), "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 GCPs, 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. Lisaise with Taiho Pharmaceuticals -Japan as needed

Responsibilities

  • Plan, conduct/coordinate GCP audits, and/or consultancy projects, as necessary, according to TOI and/or customer policies and procedures, within budget and agreed timelines.
  • Liaise with Global Regulatory Agencies.
  • Plan, schedule, prepare for, conduct audits, report, CAPA management and close out all audits undertaken. This may include, but is not limited to, audits of CROs (Systems, clinical study documents, Investigator Sites, Databases, Study Reports).
  • 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 systems and processes.
  • Address quality issues internally and with CROs.
  • Review and approval of CRO Agreements.
  • Perform other related duties as assigned.

Qualifications

  • Extensive knowledge of the pharmaceutical research and development process and the regulatory environment through which drugs receive and maintain their regulatory approval
  • Excellent GCP experience/understanding
  • Solid experience in quality assurance
  • Experience in computer systems and validation requirements
  • Knowledge and experience in regulatory requirements for submission of documents in electronic format is a plus
  • Knowledge of database, project management and spreadsheet software
  • Ability to 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
  • Ability to read, analyze and interpret scientific and technical journals and legal documents
  • Ability to respond to inquiries or complaints from regulatory agencies
  • Ability to write procedures
  • Ability to effectively present information to internal and external clients

 

Education: 

  • BS/Master’s degree with at least four years related pharmaceutical/technical experience or a Bachelor’s degree with at least 3 - 5 years related pharmaceutical/technical experience, or equivalent experience.

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