Contract, Quality Assurance – Computer System Validation (QA CSV)

Employment Type: Full-time

Position Overview

PTC Therapeutics is a global commercial biopharmaceutical company dedicated to extending life's moments for children and adults living with rare diseases. We cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

This Contract, Quality Assurance – Computer System Validation (QA CSV) role supports ongoing SAP projects at PTC Therapeutics. The position involves collaboration with cross-functional internal resources (Supply Chain, Regulatory, IT, Quality) and external resources (third-party vendors, Implementation Partners) to support SAP projects, version releases, impact assessments, and periodic reviews. The incumbent will work cross-functionally on Quality-related issues such as deviations and change controls, ensuring adherence to relevant regulatory requirements.

Visit our website to learn more about our company and culture: www.ptcbio.com

Responsibilities

• Writes and/or reviews and approves CSV documents, including but not limited to:
  • Validation Plans
  • Functional Risk Assessments
  • Application Design or Configuration Specifications
  • Applicable Test Scripts or other relevant documents
• Drives/participates in meetings with key stakeholders, providing essential inputs for the validation process and deliverable definition.
• Serves as the QA CSV point of contact and Subject Matter Expert (SME) for activities related to validation and Quality Risk Management for assigned GxP computer systems.
• Assists and/or performs quality reviews and Quality Assurance (QA) vendor audits related to computer systems.
• May assist in the management and/or oversight of other external resources for CSV-related activities.
• Reviews system master plans for alignment with corporate requirements.
• Performs GxP-related activities in alignment with business requirements, ensuring compliance with applicable regulations.
• Ensures evolving validation requirements are appropriately applied to PTC’s CSV activities.
• May write, contribute to, or edit SOPs related to the validation of GxP computer systems and/or the use or administration of validated systems.
• May assist in the development of training materials related to the validation of GxP computer systems and/or the use or administration of validated systems.
• Works closely with IT and software/system vendor(s) to ensure user/design materials and test documentation are leveraged and acceptable.
• Applies knowledge of SAP User Interfaces, Cloud-based, SaaS systems, thoroughly interprets CSV regulations, guidelines, and GxP practices to meet regulatory compliance and corporate business requirements.
• Liaises with IT and other cross-functional business teams in the development of GxP/Non-GxP deliverables, SOPs, Work Instructions, Policies, and other critical documentation.

Requirements

• Education & Experience:
  • Bachelor’s degree in a technical, scientific, or other relevant academic discipline.
  • Minimum of 6 years of experience in a pharmaceutical, biotechnology, or related environment.
  • Minimum of 3 years of experience in GxP Computer System validation or equivalent experience and/or education.
  • Experience with SAP projects is required.
• Skills & Knowledge:
  • Demonstrated, hands-on, applied knowledge and understanding of applicable GxP or other relevant regulatory authority regulations and guidance related to CSV (such as, GMP, GAMP, Part 11, Annex 11, ICH Q9, etc.) activities and compliance.
  • In-depth knowledge of relevant CFR (Title... [content truncated]

Company Information

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years, our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Learn more about our company and culture at: www.ptcbio.com