Quality Systems Manager

Position Title

Quality Systems Manager

Location

This position may be performed remotely but requires flexibility and a willingness to travel to the Boston area as needed.

Position Summary

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 possessthe 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.

Primary Responsibilities

• Design, implement, andmaintaincompany-wide stage-appropriate Quality Systems aligned withGxPprinciples.
• Regularly assess and enhanceGxPpractices to meet evolving regulations.
• Collaborate with cross-functional teams to driveGxPexcellence.
• Provide training onGxPrequirements 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.
• Conductcompliancerisk assessments, trend analysis, and provide recommendations for compliant business activities.
• Support oversight of the Supplier Quality Management program, Training, and Document Control.
• Ensureonly adequate/approved suppliers and vendors areutilizedby the company.
• Establish, compile, track, and present Quality Metrics to support Quality Management Review.
• Provide input into decisionsrequiredfor change management and CAPA programs.
• Supportinspectionreadiness 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 andtimely.
• Write, review, or approve Standard Operating Procedures and internal investigations, as applicable.

Qualifications and Key Success Factors

• 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 supportingGxP(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 ofGxPs(Good Practices), especially GMP (Good Manufacturing Practices).
• Proficiencyin 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.

Compensation & Benefits

Annualized Base Salary: $124,000 – $144,000 USD. Benefits include 99% of the premium paid for medical, dental and vision plans; company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize coverage. We match dollar-for-dollar up to 6% on eligible 401(k) contributions and offer long‑term stock incentives and ESPP. A discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays, and company‑wide shutdowns are also provided.

EEO Statement

We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.