Senior Director, Quality Excellence – Systems & Technology
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Job Description
Senior Director of Quality Excellence overseeing enterprise QMS at Praxis Precision Medicines. Responsible for quality systems governance and regulatory compliance in biotech environment.
Responsibilities:
- Lead the strategy, governance, and continuous improvement of Praxis’s enterprise QMS.
- Serve as the process owner for QMS elements including document control, deviation/CAPA management, change control, training, and risk management.
- Provide leadership and oversight for computerized lifecycle controls for GxP computerized systems.
- Partner with IT, Clinical Operations, Technical Operations, and Commercial teams to establish lifecycle standards.
- Evaluate and qualify vendors, CROs, and CMOs supporting Praxis systems.
- Maintain oversight of electronic systems, including Veeva QMS.
- Lead the global GxP training administration program.
- Establish and oversee QMS governance mechanisms.
- Ensure ongoing inspection readiness across all GxP functions.
- Monitor evolving regulatory expectations and implement timely updates to processes.
Requirements:
- BS/BA in a relevant scientific discipline, or ASQ or equivalent professional certification; equivalent experience considered.
- Minimum 15 years of progressive experience in the pharmaceutical or biotechnology industry, with direct Quality Systems and Quality Assurance experience; at least five years in a leadership role.
- Demonstrated expertise in developing, implementing, and managing enterprise QMS’ across clinical, manufacturing, and commercial functions.
- Proven success governing QMS processes such as document control, training, deviation/CAPA, change management, and risk management.
- Hands-on experience validating GxP and enterprise systems, ensuring compliance with lifecycle management.
- Demonstrated leadership experience supporting both clinical-stage and commercial operations environments.
- Documented history supporting regulatory inspections and partner audits.
- Strong working knowledge of FDA, EMA, and global GxP regulations and application of GAMP 5 guidance.
- Demonstrated ability to analyze and optimize quality processes, establish performance metrics, and lead governance forums.
- Strategic, solutions-driven quality leader with excellent collaboration, communication, and influencing skills.
- Proficient in Veeva Vault applications, DocuSign, and SharePoint.
Benefits:
- 99% of the premium paid for medical, dental and vision plans.
- Company-paid life insurance, AD&D, disability benefits.
- Voluntary plans to personalize your coverage.
- 401(k) matching up to 6% on eligible contributions.
- Long-term stock incentives and ESPP.
- Discretionary quarterly bonus.
- Flexible wellness benefit.
- Generous PTO, paid holidays, and company-wide shutdowns.
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