Manager / Senior Manager Quality Management Systems

Praxis Precision Medicines, Inc.-posted 3 days ago
Full-time • Mid Level
Remote
101-250 employees
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The Manager, Quality Management Systems (QMS) is responsible for implementing, and maintaining the company’s global Quality Management System to ensure compliance with applicable pharmaceutical regulations, industry standards (e.g., ICH, GMP, ISO 9001), and company policies. This role provides leadership in continuous improvement of quality processes, oversight of quality documentation, change control, deviation and CAPA systems, and internal audits. The QMS Manager partners cross-functionally to promote a culture of quality, compliance, and operational excellence.

  • QMS Oversight: 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).
  • Documentation Control: Oversee document management processes, ensuring timely creation, review, approval, and archiving of controlled documents (SOPs, policies, quality manuals).
  • Deviation and CAPA Management: Lead the deviation, investigation/audit, and corrective/preventive action (CAPA) processes to ensure timely closure and root cause identification.
  • Change Control: Manage the change control system, ensuring changes are risk-assessed, justified, and properly implemented.
  • Inspections Readiness: Coordinate internal audits; prepare for and support regulatory inspections; track and implement corrective actions.
  • Metrics & Reporting: Develop and monitor QMS performance metrics and quality KPIs; present trends and improvement plans to senior management.
  • Continuous Improvement: Drive process improvement initiatives to enhance QMS efficiency and effectiveness using tools such as risk-based approaches and Agile methodology.
  • Cross-functional Collaboration: Partner with departments across organizations to ensure consistent implementation of quality standards and best practices.
  • 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.
  • Advanced degree (MSc, MBA) preferred.
  • 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
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