Senior Manager, Computer System Validation QA

Senior Manager, Computer System Validation QA

Remote - USA

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'llask"why not?" and help reengineer the future of biopharma. At Bridge Bio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.

The Senior Manager, Computer System Validation (CSV), QA will report to the Sr. Director, QA Ops and Inspection Management. This position will provide quality oversight of the computer system validation lifecycle from design and implementation to retirement, ensuring compliance of GxP applications. This role will ensure that all GCP/GVP computerized systems are validated for intended use, and maintained in compliance with Health Authority requirements.

This position partners cross-functionally with IT, GMP Quality Assurance, and functional area system owners, business process owners, and service providers to apply a documented, risk-based approach to validation and compliance.

Responsibilities

• Provide QA oversight of the GCP/GVP computer system validation lifecycle, ensuring ongoing compliance and a validated state through design, configuration, updates, and maintenance.
• Review and approve computer system risk assessments to determine the scope and level of validation required for system implementation.
• Review and approve IT change control and validation deliverables, including protocols, test scripts, and reports of the GCP/GVP validated system.
• Participate, review, and approve periodic system and user reviews, identifying and remediating compliance gaps.
• Collaborate with IT and cross-functional stakeholders such as business owners, to establish and enforce requirements for system validation, data integrity, and ongoing system maintenance.
• Support the computer system audit program by participating in audit activities including audit report and CAPA reviews.
• Project manage the implementation, configuration, and continuous enhancement of GCP/GVP and QMS computer systems.
• Drive continuous improvement initiatives for QMS and validated GxP systems.
• Support inspection readiness and regulatory inspection activities including serving as a QA CSV subject matter expert and response/CAPA management through timely resolution and closure.
• Review and approve GxP-computer system and business process procedures, and support end-user training to ensure proper adoption and compliance.
• Support organizational artificial intelligence (AI) governance as the GCP/GVP Quality representative

Education, Experience & Skills Requirements

• Bachelor’s or Master’s degree in software, computer engineering, or technical field.
• 8+ years of experience in quality systems development and maintenance within clinical and commercial-stage pharmaceutical or biotech companies.
• Excellent attention to detail and strong organizational skills.
• Effective communication skills both written and verbal.
• Demonstrated expertise in GxP computerized system validation/assurance…