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 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. 

Primary Responsibilities 

• 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. 

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 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. 

Compensation & Benefits 

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let’s achieve the impossible together!