• Under the direction of the Head of R&D Technology QA & Compliance, this position is responsible for providing support in the management and QA oversight of Computerized Systems Validation activities related to Shire systems utilized by R&D
• Principal responsibilities include:
• Provides professional expertise, guidance and strong leadership in Computer System Validation and applicable regulatory requirements (21 CFR Part 11/Annex 11/ GAMP 5) as applicable to the Global R&D GxP requirements (GLP, GCP, GPvP, GDP) to proactively identify compliance issues/risks in all functions within the organization and its external partners.
• Liaise with various internal groups and external groups including Contract Research Organizations (CROs), regulatory bodies, expert consultants and vendors, to maintain a high level of quality and consistency across the programs / projects in R&D.
• Fosters relationships with Global R&D staff to encourage discussion and evaluation of best practices for continuous improvement of quality and compliance across programs.
• Represent R&D in interactions with various Shire groups outside of R&D (TechOps, IT, etc) to evaluate best practices for continuous improvement of Computer System Validation compliance across Shire.
• Coordinates and collaborates with the internal QA & C CoEs to provide consistency across QA&C process as well as programs and reporting
• Represent R&D in ensuring the enterprise applications are designed, validated and maintained in a manner which supports the use of these applications in compliance with Global R&D regulations.
Update and maintain required Technology QA & Compliance Audit program (internal and external) and related documentation
• Serve as a Subject Matter Expert (SME) in Computer System Validation requirements for systems used by Shire's global R&D Organization.
• Manage the development, implementation and maintenance of the Quality Assurance programs and activities in support of R&D computerized systems used to support regulatory applications environment to ensure compliance with Domestic and International requirements
• Provide guidance to R&D Sr Management in preparation for regulatory inspections
• Serve as key company representative and SME during any global R&D agency inspection
• Develop positive working relationships with global R&D stakeholders and ensure that compliance objectives are met.
• Develop and/or review all responses to regulatory agency inspections and corrective action commitments related to CSV requirements, ensure that timely responses are generated.
• Ensure Quality Assurance oversight and involvement in Computer Validation Projects supporting R&D activities
• Manage/perform internal and external audits to evaluate computerized system vendors, external hosting providers, and internal validation project deliverables
Continuous Improvement & Procedural Documentation
• In collaboration with other CoEs in R&D QA&C identify the need for and deliver appropriate training to stakeholders/ validation teams as well as CSV training to all R&D personnel involved in CSV projects.
• Conduct focused training as necessary
• Establish and maintain a periodic review system to assure computer systems are maintained in a validated state and in compliance with Procedural Documents and domestic/international regulations and guidance
• Direct and administer programs for measuring compliance by establishing metrics on critical quality endpoints and provide periodic reports to management with recommendations for continuous quality improvements
• Lead the development and maintenance of processes and procedures which support computer system validation requirements.
• Evaluate computer system change controls and ensure adequate testing and documentation is maintained
R&D Quality Operations Leadership
• Ensure that objectives of the Technology QA & Compliance are defined and communicated to cross-functional groups within R&D and across the Shire organization (Corporate/Enterprise wide and TechOps)
• Participate in R&D QA & Compliance projects having impact across all of R&D/ all of Shire
Education & Experience Requirements:
• Bachelor's degree in a life science or computer science required; Masters Degree in management or scientific discipline a plus.
• At least 10 years of pharmaceutical experience.
• Ideal candidate will have broad experience in computer system life cycle development;/computer system validation in R&D.
• Idea candidate will have demonstrated experience leading cross functional teams without authority, advising on compliance related matters, and influencing Sr Leaders
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.