Praxis

Manager – Senior Manager, Quality Management Systems

Praxis

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇺🇸 United States

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Salary

💰 $107,000 - $137,000 per year

Job Level

Senior

Tech Stack

Vault

About the role

  • 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.

Requirements

  • Bachelor’s degree in Life Sciences, Engineering, or a related field required.
  • Advanced degree (MSc, MBA) preferred.
  • 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.
Benefits
  • 99% of the premium paid for medical, dental and vision plans.
  • Company-paid life insurance, AD&D, disability benefits, and voluntary plans.
  • 401(k) contributions matched dollar-for-dollar up to 6%.
  • Long-term stock incentives and ESPP.
  • Discretionary quarterly bonus.
  • Extremely flexible wellness benefit.
  • Generous PTO, paid holidays and company-wide shutdowns.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
Quality Management SystemGMPICH Q10CAPAdocument managementprocess improvementrisk assessmentquality KPIsanalytical skillsproblem-solving
Soft skills
leadershipcommunicationinterpersonal skillsdecision-makingmentorshipcross-functional team leadershiporganizational skillsability to manage multiple prioritiescontinuous improvement mindsetquality culture development