Praxis Precision Medicines, Inc. · 3 weeks ago
Manager / Senior Manager Quality Management Systems
United States
Full-time
Remote
Mid, Senior Level
$107K/yr - $137K/yr
7+ years expPraxis Precision Medicines is a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system disorders. The Manager, Quality Management Systems (QMS) is responsible for implementing and maintaining the global Quality Management System to ensure compliance with pharmaceutical regulations and standards, while driving continuous improvement and cross-functional collaboration.
Alternative MedicineBiotechnologyHealth CareMedicalPrecision Medicine
Responsibilities
Manage and continuously improve the Quality Management System, ensuring alignment with global regulatory requirements (e.g., FDA 21 CFR Parts 210/211, EU GMP, ICH Q10)
Oversee document management processes, ensuring timely creation, review, approval, and archiving of controlled documents (SOPs, policies, quality manuals)
Lead the deviation, investigation/audit, and corrective/preventive action (CAPA) processes to ensure timely closure and root cause identification
Manage the change control system, ensuring changes are risk-assessed, justified, and properly implemented
Coordinate internal audits; prepare for and support regulatory inspections; track and implement corrective actions
Develop and monitor QMS performance metrics and quality KPIs; present trends and improvement plans to senior management
Drive process improvement initiatives to enhance QMS efficiency and effectiveness using tools such as risk-based approaches and Agile methodology
Partner with departments across organizations to ensure consistent implementation of quality standards and best practices
Qualification
Required
Bachelor's degree in Life Sciences, Engineering, or a related field required
7+ years of experience in pharmaceutical or biopharmaceutical quality assurance, with at least 3 years in a leadership or managerial role
Strong working knowledge of GMP, ICH Q10, and global regulatory expectations
Experience with Veeva Vault Quality and QMS platforms
Demonstrated success in preparing for and hosting regulatory inspections (FDA, EMA, MHRA, etc.)
Proven ability to lead cross-functional teams and drive continuous improvement
Excellent knowledge of quality systems and regulatory frameworks
Strong analytical, problem-solving, and decision-making abilities
Effective communication and interpersonal skills at all organizational levels
Ability to manage multiple priorities in a fast-paced, regulated environment
Leadership mindset with a focus on mentorship and quality culture development
Preferred
Advanced degree (MSc, MBA) preferred
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) contributions
Long-term stock incentives
ESPP
Discretionary quarterly bonus
Flexible wellness benefit
Generous PTO
Paid holidays
Company-wide shutdowns
Company
Praxis Precision Medicines, Inc.
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.
51-200 employees
H1B Sponsorship
Praxis Precision Medicines, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.67BKey Investors
Eventide
2026-01-06Post Ipo Equity· $575M
2025-10-16Post Ipo Equity· $525M
2024-03-28Post Ipo Equity· $200M
Leadership Team
Marcio Souza
President and CEO
Tim Kelly
Chief Financial Officer
Recent News
2026-01-07
2026-01-07
Company data provided by crunchbase