Manager, R&D Quality Risk Management V

Manager, R&D Quality Risk Management V

Position Summary: Responsible for planning, writing, implementing and reviewing computer system validation (CSV) protocols of GxP computerized systems. Serve as the CSV subject matter expert and provide guidance on and interpretation of global GxP guidance and regulations of computerized systems, electronic records, electronic signatures, and data integrity requirements. Collaborate with peers across on procedures relating to quality, data integrity and computer system validation.

Primary Responsibilities:

• Responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with global regulatory guidelines.
• Provide input into developing scope, actions, and timelines on computer system validation projects and be accountable for implementing and validating computerized systems, including reviewing and approving validation deliverables and change controls.
• Contribute expertise and provide guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participate in assessments.
• Collaborate with IT teams, vendors, business users, and internal quality compliance staff to ensure that CSV activities are planned and executed in accordance with internal procedures.
• Evaluate and maintain quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements.
• Represent quality, compliance and validation controls to cross-functional business leaders when needed, including managing escalations as needed.
• Ensure quality systems procedures, systems and processes are effective and meet regulatory requirements and business needs.
• Provide support for inspection readiness activities.
• Perform periodic review analysis of validation documentation, systems and practices.
• Responsible for generating a risk-based strategy across the GxP landscape that identifies and manages issues and risks related to data integrity as well as a continuous improvement process that assures continuous compliance with global DI standards.
• Other duties as assigned/required.

Skills:

Experience with System Periodic Review and system audit trail highly desirable. Candidate must be a subject matter expert in computer system validation, GAMP, Electronic Records/Electronic Signature regulations, and related health authority regulations and guidelines. Candidate must be technically conversant in concepts and techniques related to software development and data management. Demonstrated ability to plan and organize effectively across multiple projects and tasks. Demonstrated ability to influence, collaborate, and communicate directly at various organizational levels. Proficiency in Microsoft Excel, Word, and Outlook. Critical thinking skills in analyzing and exercising judgment on complex issues, guided by a thorough understanding of quality philosophy. Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up and judgment and ability to prioritize. Skilled at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines. Able to gain the cooperation of others.

Education:

Bachelor's degree or equivalent in computer science, engineering, life science or related field. A minimum of 5 years of experience in computer systems validation in the pharmaceutical industry, including at least 2 years managing/overseeing computer system validation projects.