Director of IT Computer System Validation
Company: Seagen
Location: Bothell
Posted on: January 14, 2021
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Job Description:
DescriptionSummary:Information Technology Computer System
Validation (IT CSV) Director will lead a team of IT CSV specialists
in an important role of compliance and oversight for the System
Development Life Cycle with focus on Computer Systems Validation
globally. This leader will focus on maintaining strong
collaboration and alignment with business quality units and various
IT departments in ensuring GxP requirements, internal and external,
are continuously met for ensuring patient safety and product
compliance at Seagen.This role consults and educates business
groups on effective integration of compliance requirements into the
IT lifecycle activities and will serve as the IT point person for
internal and external audits and inspections.The IT CSV director
will champion Computer System Validation and Information Technology
strategies to support the business strategy of continued growth and
improved process efficiency. Principal Responsibilities:Provides
guidance on requirements definition, ensures validation,
implementation, and change management process of IT portfolio of
applications, systems, platforms in GxP environment are conducted
in compliance with applicable regulations and company
proceduresEngages with peers in business groups to gain
cooperation, foster collaboration, understand business needs and
positively influence outcomes e.g., CSV deliverablesDevelops
programs to provide executive reports for senior management on a
regular cadenceDevelops and implement standard templates and
processes to support validated systems, understands regulations,
industry best practicesLead the development, expansion, and
improvement of lean practices (tools, templates, standards, work
instructions) for IT systems validation, lifecycle control, and
data integrity for new and existing systems to comply with
Seagen---s policies and proceduresProvides framework for validation
activities within IT, including assessments, requirements
gathering, testing, etc.Leads teams in remediating GxP systems
related deviations, CAPAs and change records and ensures
appropriate failure investigations and identification of root cause
analysis are performedManages and monitors defect reports and works
with system stakeholders to verify resolutionOversees and managers
the IT compliance efforts within a project or activity. Guides the
efforts of staff assigned to projects or activities that involve a
validation componentLead collaborations to incorporate and align
CSV expectations with standard IT processes such as ITIL
methodologiesCommunicates status, solutions, and concerns to
stakeholders and senior leadershipDisseminates information in a
timely manner within the team. Facilitates and addresses issues
within project. Resolves issues and removes roadblocks
quicklySupports project teams to ensure that validation
deliverables meet standards, as appropriateManages a team of IT CSV
expertsContributes to operational and process improvement
initiatives related to IT Quality and Compliance with periodic
reviews and updates of IT policies, standards and
proceduresRequired Qualifications:Master---s degree in Computer
Science, Business Administration, a related field or related
equivalent combination of education and experience with a minimum
of 10 years managing and/or supporting Computer System/Software
Validation in biotechnology, bio-pharmaceutical or manufacturing
industriesExcellent working knowledge of cGMP requirements and FDA
guidelines, specifically 21 CFR Part 11 and Data
IntegrityExperience working with FDA, EMA and other global
regulatory agencies requirementsExperience with creating SOPs,
deviations, corrective actions, and controlled documents is
mandatoryProven record in problem solving and successful
collaborations across multiple functions and
departmentsDemonstrated experience with the implementation or
oversight of validated systems in both on-prem and Software as a
Service (SaaS) environments in the pharmaceutical industryInfluence
Skills: ability to factually resolve conflicts and differences of
opinion in a respectful yet assertive wayExcellent verbal and
written communication skillsAbility to troubleshoot issues and work
independently with minimal directionSelf-motivated with high degree
of initiative and excellent follow-up skills, along with strong
analytical and problem-solving skillsAn expert at integrating
business operations leveraging appropriate risk management
techniques Preferred Qualifications:At least 5 years working in
Information Technology is preferredA background in clinical and
manufacturing systems is desirableCPVP, GMPCP, PMP certifications
preferredAs the leading employer in our industry in the Pacific
Northwest, Seagen is proud to offer a competitive total
compensation package as well as a comprehensive benefits program
designed to support the whole lives of our employees and their
families. Benefits include medical, vision and dental coverage,
group and supplemental life insurance, 401(k) with company match,
tuition reimbursement, relocation assistance and much more. To
learn more about Seagen, please visit . Seagen is an equal
opportunity employer. All qualified applications will receive
consideration for employment without regard to race, age, gender
identity, sexual orientation, color, religion, sex, marital status,
national origin, protected veteran status, disability status, or
any other status protected by federal, state, or local law.
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Keywords: Seagen, Seattle , Director of IT Computer System Validation, IT / Software / Systems , Bothell, Washington
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