Manager/Sr Manager, Quality Systems 

Reports to: VP, Quality

Location: This position may be performed remotely with travel to the Boston area as needed.

Position Summary 

The Manager/Sr. Manager, Quality Systems, reporting to the VP Quality, is responsible for ensuring GxP compliance across all areas of Praxis programs. They will 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 the internal advisor on GxP compliance and fostering collaborations across various departments. The Manager/Sr. Manager will develop a tailored Quality compliance strategy for Praxis and establish a proficient Quality Systems team 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 proficiency to navigate complex regulatory landscapes, build effective internal partnerships, and champion Quality compliance excellence within the organization. The Manager/Sr. Manager, Quality Systems will play a critical role in advancing Praxis' mission, bringing innovative solutions to the forefront, 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. 

• Develop and coaching and mentoring on Quality best practices, procedures, record review, and regulatory requirements. 

• Oversee and assist with implementing and training on new quality processes, supporting quality management initiatives. 

• Conduct compliance risk assessments, trend analysis, and provide recommendations for compliant business activities. 

• Oversee 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 guidance for higher-level decisions required for change management and CAPA programs. 

• Provide primary support, planning, and participation in internal and external, and other regulatory agency inspections to ensure compliance with procedures and author responses. 

• Monitor industry inspection trends, regulations, and guidelines for impact on programs and operations. 

• Work with department heads to establish and maintain data integrity initiatives. 

• Supply feedback on trends and serious quality issues or non-compliances detected by QA staff during GMP and GDP activities. 

• Ensure that CAPAs resulting from audits associated with the assigned programs and studies are allocated a CAPA owner and closed out appropriately and timely. 

• Write, review, or approve Standard Operating Procedures and internal investigations, as applicable. 

• Proactively influence management regarding the adoption of standards to improve quality, efficiency, and compliance within Dechra. 

Qualifications and Key Success Factors 

• Education and Experience: 

• 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. 

• 7 years of relevant quality experience, including implementing and managing GxP (Good Practice) quality systems within the pharmaceutical or biotech industry. 

• Technical Skills and Expertise: 

• Electronic Document Management Systems (EDMS): Significant experience in assessing and implementing EDMS and QMS (Quality Management Systems). Familiarity with Veeva is preferred. 

• Quality Systems and Operations: Proven experience working in quality systems and/or quality operations. 

• Regulatory Knowledge: Strong knowledge of global regulations, particularly those from the EU and US. 

• GxP Understanding: In-depth understanding of GxPs (Good Practices), especially GMP (Good Manufacturing Practices). 

• Personal Attributes and Abilities: 

• Prioritization and Multitasking: Ability to prioritize and balance work across multiple projects simultaneously. 

• Motivation and Flexibility: Highly motivated, flexible, and excellent organizational skills. 

• Collaboration: Collaborative mindset, working effectively with partners and internal customers to advance the company’s mission. 

• Communication Skills: Excellent oral and written English communication skills. 

• Integrity and Leadership: High integrity and the ability to bring out the best in others, both intellectually and interpersonally, within cross-functional teams. 

• Strategic Thinking: Demonstrated strategic and critical thinking skills. 

• Problem-Solving and Judgment: Ability to address complex problems and find solutions across multiple projects. 

• Curiosity and Innovation: Demonstrates a high level of intellectual curiosity, innovation, and creative problem-solving, with an entrepreneurial spirit. Thrives in an agile environment. 

• Core Values: Exemplifies the core values of the organization, such as trust, ownership, curiosity, and results. 

• Industry-Specific Experience: 

• Pharmaceutical GMP Environment: Solid experience working in a pharmaceutical GMP environment. 

• QA/QS Role: Exceptional experience in a quality assurance (QA) and/or quality systems (QS) role within pharmaceutical manufacturing. 

1. Software Proficiency: 

• Proficiency in Microsoft Office, particularly Excel, PowerPoint, and Word. 

• Familiarity with CITI is a plus. 

Compensation & Benefits 

At Praxis, we’re proud to offer an exceptional benefits package that includes: 

• 99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plans 

• Bonus program structured to pay on a quarterly basis 

• 401k plan with 100% match up to 6% of employee’s contribution (Traditional & Roth) 

• Wellness benefit of $200/month towards incredibly flexible options including travel, fitness equipment & memberships, student loan repayment, sports fees and much more 

• Unlimited PTO, (2) weeklong shutdowns each year, and a generous extended family leave benefit 

• Eligibility for equity awards and Employee Stock Purchase Plan (15% discount) 

To round out this world-class total rewards package, we provide base salary compensation in the range of $125,000 to $155,000 annualized. Final salary range may be modified commensurate with job level, education, and experience. 

Company Overview

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. 

Diversity, Equity & Inclusion 

Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE™ to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. 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.

Attention: Job Scam Alert 
Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to careers@praxismedicines.com. 

Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.