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Praxis logo
Praxis

Focused patient recruitment.

Quality Operations Manager – CMC

OperationsOperationsFull TimeRemoteSeniorTeam 11-50Since 2002H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

178 days ago

Salary

$90K - $107K / year

Seniority

Senior

Bachelor Degree5 yrs expEnglish

Job Description

Quality Operations Manager – CMC

Praxis

• Oversee drug substance, drug product, and packaging/labeling contract service providers. • Review and approve product/process documents. • Support stability program strategy for products. • Lead change controls, deviations, and investigations. • Perform risk assessment and implement quality controls. • Support vendor qualification program. • Development and review of Quality Agreements. • Act as Product Quality Lead in cross-functional team meetings. • Coordinate to ensure regulatory requirements are met. • Direct disposition activities with a QP. • Collaborate across CSPs for timely review of manufacturing records. • Implement robust processes for product management. • Interface with Regulatory Affairs for filings. • Support pre-approval inspections and audits.

Job Requirements

  • BA or BS degree in Chemistry or related field
  • 5+ years in a GMP setting working with clinical and commercial products
  • Firsthand experience with interpreting and implementing regulatory standards (e.g., ISO, FDA, ICH, GMP, EMA).
  • Proven track record in supporting regulatory inspections (FDA, EMA)
  • Strong knowledge of quality management systems, QC and development processes, and regulatory strategy for small molecule DS and solid oral drug products.
  • Experience with disposition of product batches and interfacing with a QP and CSPs.
  • Excellent written, organizational, and oral communication skills.
  • Must thrive working in a fast-paced, innovative environment.
  • Experience with product monitoring, complaint handling, and issue resolution preferred.
  • Demonstrates intellectual curiosity, innovation, and creative problem-solving.
  • Excellent interpersonal skills with the ability to develop important relationships.

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.
  • Flexible wellness benefit.
  • Generous PTO and paid holidays.
  • Company-wide shutdowns.
  • Supportive and engaged work environment.

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