Manager/Senior Manager, Digital Quality and Data Integrity
Agios (agios.com) is a biopharmaceutical company committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with cancer and rare genetic diseases. We are growing rapidly with an active research and discovery pipeline across both therapeutic areas. Agios has two approved oncology precision medicines and multiple first-in-class investigational therapies in clinical and/or preclinical development.
Agios is seeking a highly motivated Manager/ Senior Manager level individual to confidently drive GxP computer system validation and compliance projects from a strong strategic and technical perspective. In this visible and strategic partnering role, you will be expected to partner with business owners, IT, QA, and external service providers to establish and maintain GxP computer systems and their data throughout the entire systems and data life cycle.
Duties and Responsibilities:
* Creates, maintains, reviews and revises quality systems and procedures that ensure GxP computer systems are operated and maintained in a validated state and in a continual state of inspection readiness with regards to cGxP.
* Ensure GxP computer systems are designed, validated, and maintained in an appropriately risked based and compliant state throughout the entire systems and data lifecycles.
* Responsible for qualification of third party systems and vendors.
* Ensure GxP requirements are aligned with applicable regulatory requirements and internal procedures and Health Authority Regulations, including FDA, TGA, JPMH, EU, CFDA, etc.
* Authors protocols, reports, test scripts, and SOPs supporting GxP computer system validation.
* Establishes key objectives and metrics to support validation of GxP computer systems.
* Review and approve proposed changes and implementation plans to computer systems and procedures, as appropriate.
* Review technical/investigation reports as appropriate.
* Participates in regulatory and internal audit inspections.
* Monitors, tracks and trends findings/corrective and preventive actions resulting from system audits. Supports implementation of system CAPAs and ensures timely closure.
* Reviews routine metrics and systems reports and facilities development of appropriate action plans as well as communication with key stakeholders.
* Perform other duties as required.
Skills and Qualifications
* Bachelor's Degree in a technical discipline (Computer Science, Engineering or similar).
* 8+ years of Computer System Validation experience in a GxP pharmaceutical environment.
* Working knowledge of quality systems and regulatory requirements (21 CFR Part 11, 210, 211,58, 820, ICH 8, ICH 9, ICH 10, Annex 11, etc.).
* Data integrity guidance (e.g., FDA, MHRA, CFDA, etc.).
* Strong knowledge of GMP, GAMP, technical writing principles and quality systems.
* Strong knowledge of IT compliance SOPs including change control practices/strategies, and system risk assessments.
* Proficient in MS Word, Excel, Power Point and other applications.
* Excellent written and verbal communication skills.
* Ability to communicate and work independently with scientific/technical personnel.
* Analytical thought leader with strong ability to anayze systems, data, validation plans and reports to identify creative solutions to appropriately mitigate technical risks.
* Skilled presenter with ability to convey technical information to an audience at all levels within the organization.
* Collaborative yet decisive leader with track record for creating agile solutions.
About Agios Pharmaceuticals
Agios Pharmaceuticals is a biopharmaceutical company discovering and developing therapeutics for cancer metabolism.