Looking for a chance to make a real 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 value our employees, who work
relentlessly to help us 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 our
patients, our partners, and each other. Together, we’re working to discover and
develop innovative cancer treatments that address unmet patient needs and apply
the science behind them in novel ways. As the field of cancer treatment
evolves, we evolve with it. Advanced technology, dedicated investigators, and
incomparable facilities: these vast resources empower us to redefine the way
the world treats cancer. It’s our work, our passion, and our legacy. If the
prospect of being part of this sounds exciting, we invite you to join us.
Hybrid Role
Position Summary
Provide strategic oversight to ensure Taiho Oncology
computerized systems are deployed following a risk-based compliance framework
to ensure compliance with associated regulatory and security requirements.
Responsibilities
and Duties:
Manage day-to-day operations of the Computer Software
Assurance function within IT.
Coordinate all validation activities with outsourced
validation vendor.
Act as primary point of contact for IT during internal
and external inspections and provide responses to observations.
Think critically and guide others to think critically to
assess system risk to patient safety and product quality and devise testing
strategies aligned with CSA.
Serve as a Computer System Validation Subject Matter
Expert and provide strategic and consistent guidance.
Oversee and lead the development of Computer System Validation (CSV) and operational strategies by establishing or updating governing policies and procedures aligned to FDA’s Computer Software Assurance (CSA) draft Guidance.
Ensure company’s GxP computerized IT systems are tested, validated and controlled to comply with applicable regulations (e.g. 21 CFR Part 11, 58, 210, 211, and 820, Annex 11).
Facilitate audits of IT vendors to ensure supported software and services are in a state of control and Taiho Oncology can leverage such audits and vendor documentation to reduce delivery efforts internally.
Manage the development of system specific validation
plans and strategy using a risk-based approach aligned with computer software
assurance methodologies.
Author and revise validation documents such as SOPs, protocols, and work instructions as necessary.
Assess and provide estimates to determine validation work effort and estimate the necessary time-to-completion.
Manage creation of test plans and scenarios.
Manage the Data Integrity Program.
Ensure completed validation and qualification document
packages are maintained in a well-organized archive that is easily and quickly
retrieved for inspections.
Anticipate, budget, and execute all CSV support for new
projects, enhancements, and ongoing changes to production.
Closely work with the IT Applications, IT Infrastructure,
and IT Security groups in NJ and Japan on various projects.
Educational
Requirements:
Bachelor’s degree from an accredited college or university in Computer Science, Engineering, or related IT field.
Experience:
10+ years' experience in a management validation role
with responsibility for computer systems.
5 years' developing and managing projects budgets and
forecasts.
Demonstrated knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs).
Demonstrated knowledge and expertise in CSV related regulatory requirements (FDA, 21 CFR).
Knowledgeable of FDA regulations regarding the Validation Life Cycle and the Software Development Life Cycle.
Knowledge and understanding of the GAMP 5 2nd Edition.
Experience in the computer systems validation (CSV) of enterprise systems.
Experience in the FDA Computer Software Assurance (CSA) fundamental concepts for leveraging vendors, automation and a patient / product / data risk-based testing approach.
Understanding of document management principals.
2 years’ experience providing oversite to Cloud and GCP
computer systems validation activities.
Experience validating GCP applications, IT
infrastructure, and cloud-based systems.
Experience managing oversite of multiple enterprise
projects and processes at one time.
Strong customer service skills for internal and external customers.
Ability to multi-task and prioritize efforts effectively.
