Seagen

Director of IT Computer System Validation

Description

Summary

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 procedures
• Engages with peers in business groups to gain cooperation, foster collaboration, understand business needs and positively influence outcomes e.g., CSV deliverables
• Develops programs to provide executive reports for senior management on a regular cadence
• Develops and implement standard templates and processes to support validated systems, understands regulations, industry best practices
• Lead 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 procedures
• Provides 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 performed
• Manages and monitors defect reports and works with system stakeholders to verify resolution
• Oversees 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 component
• Lead collaborations to incorporate and align CSV expectations with standard IT processes such as ITIL methodologies
• Communicates status, solutions, and concerns to stakeholders and senior leadership
• Disseminates information in a timely manner within the team. Facilitates and addresses issues within project. Resolves issues and removes roadblocks quickly
• Supports project teams to ensure that validation deliverables meet standards, as appropriate
• Manages a team of IT CSV experts
• Contributes to operational and process improvement initiatives related to IT Quality and Compliance with periodic reviews and updates of IT policies, standards and procedures

Required 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 industries
• Excellent working knowledge of cGMP requirements and FDA guidelines, specifically 21 CFR Part 11 and Data Integrity
• Experience working with FDA, EMA and other global regulatory agencies requirements
• Experience with creating SOPs, deviations, corrective actions, and controlled documents is mandatory
• Proven record in problem solving and successful collaborations across multiple functions and departments
• Demonstrated experience with the implementation or oversight of validated systems in both on-prem and Software as a Service (SaaS) environments in the pharmaceutical industry
• Influence Skills: ability to factually resolve conflicts and differences of opinion in a respectful yet assertive way
• Excellent verbal and written communication skills
• Ability to troubleshoot issues and work independently with minimal direction
• Self-motivated with high degree of initiative and excellent follow-up skills, along with strong analytical and problem-solving skills
• An expert at integrating business operations leveraging appropriate risk management techniques

Preferred Qualifications:

• At least 5+ years working in Information Technology is preferred
• A background in clinical and manufacturing systems is desirable
• CPVP, GMPCP, PMP certifications preferred

As 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 www.seagen.com.

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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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 12/04/2020