[Hiring] Quality Systems Manager @Praxis Precision Medicines, Inc.

Role Description

The Quality Systems Manager is responsible for supporting GxP compliance across Praxis programs. They will help design, implement, maintain, and enhance Quality Systems company-wide, including development, pre-clinical, clinical, safety, validation, registration, and commercialization efforts. This role involves serving as a key contributor on GxP compliance and fostering collaborations across various departments. The Quality Systems Manager will contribute to the development and execution of a tailored Quality compliance strategy for Praxis and support the evolution of Quality Systems aligned with the company's path to commercialization.

The ideal candidate will thrive in a results-driven, highly accountable setting with significant potential for impact. They should possess the ability to navigate regulatory landscapes, build effective internal partnerships, and support Quality compliance excellence within the organization. The Quality Systems Manager will contribute to advancing Praxis' mission and driving continuous improvement in Quality Systems to support the company's growth and success.

Qualifications

• Bachelor’s degree in life sciences, engineering, or a related field (with a preference for Chemistry or Biology) or an equivalent combination of education and relevant job experience may also be considered.
• 5–7 years of relevant quality experience, including implementing and supporting GxP (Good Practice) quality systems within the pharmaceutical or biotech industry.
• Experience in Electronic Document Management Systems (EDMS) and Quality Management Systems (QMS); familiarity with Veeva is preferred.
• Experience working in quality systems and/or quality operations.
• Strong knowledge of global regulations, particularly those from the EU and US.
• Strong understanding of GxPs (Good Practices), especially GMP (Good Manufacturing Practices).
• Proficiency in Microsoft Office, particularly Excel, PowerPoint, and Word.
• Experience working in a pharmaceutical GMP environment.
• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Requirements

• Design, implement, and maintain company-wide stage-appropriate Quality Systems aligned with GxP principles.
• Regularly assess and enhance GxP practices to meet evolving regulations.
• Collaborate with cross-functional teams to drive GxP excellence.
• Provide training on GxP requirements to personnel at all levels.
• Provide coaching and guidance on Quality best practices, procedures, record review, and regulatory requirements.
• Support implementation and training on new quality processes, supporting quality management initiatives.
• Conduct compliance risk assessments, trend analysis, and provide recommendations for compliant business activities.
• Support oversight of the Supplier Quality Management program, Training, and Document Control.
• Ensure only adequate/approved suppliers and vendors are utilized by the company.
• Establish, compile, track, and present Quality Metrics to support Quality Management Review.
• Provide input into decisions required for change management and CAPA programs.
• Support inspection readiness activities, including participation in internal and external audits and regulatory inspections.
• Monitor industry inspection trends, regulations, and guidelines for impact on programs and operations.
• Work with department heads to support data integrity initiatives.
• Provide feedback on trends and quality issues or non-compliances detected during GMP and GDP activities.
• Ensure that CAPAs associated with assigned programs and studies are tracked and closed out appropriately and timely.
• Write, review, or approve Standard Operating Procedures and internal investigations, as applicable.

Benefits

• 99% of the premium paid for medical, dental, and vision plans.
• Company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage.
• Dollar-for-dollar match up to 6% on eligible 401(k) contributions.
• Long-term stock incentives and ESPP.
• Discretionary quarterly bonus.
• Extremely flexible wellness benefit.
• Generous PTO, paid holidays, and company-wide shutdowns.
• Join a phenomenal crew of colleagues who are smart, engaged, and inspiring.

Company Description

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.