Supervisor, Quality Operations

3 weeks ago
Full-time
Senior
Quality Assurance and Testing
Empower Pharmacy

Empower Pharmacy

Empower Pharmacy operates as a 503A compounding pharmacy and FDA registered 503B facility, specializing in the production of high-quality, personalized medications to enhance the health and well-being of patients across the United States.

Health Care Providers & Services
251-1K
Founded 2009

Description

  • Lead daily batch record review, quality assessment, and lot disposition across manufacturing operations.
  • Direct deviation, excursion, nonconformance, and quality event investigations, including containment, root cause analysis, and resolution.
  • Oversee CAPA processes from initiation through effectiveness verification.
  • Review and approve quality-related changes through the change control process.
  • Maintain oversight of cGMP compliance, procedural adherence, and quality system effectiveness.
  • Lead, coach, and develop quality team members through performance management, training, and collaboration.
  • Partner with Manufacturing, Validation, Engineering, Laboratory, and Regulatory teams to resolve issues and improve processes.
  • Identify and implement process improvements to reduce inefficiencies and strengthen quality performance.
  • Drive proactive risk assessment and mitigation activities across quality operations.
  • Ensure ongoing inspection readiness for internal audits, customer assessments, and regulatory inspections.

Requirements

  • Minimum of 3 years of experience in pharmaceutical quality, including 2 years in a supervisory role.
  • Bachelor of Science degree in a technical or scientific discipline.
  • Advanced knowledge of cGMP regulations, aseptic manufacturing, quality systems, investigations, CAPA management, batch record review, and risk-based decision-making.
  • Proficiency with quality management systems, electronic documentation platforms, data analytics tools, and AI-enabled technologies.
  • Strong leadership, coaching, communication, and stakeholder management skills.
  • Ability to analyze data, identify trends, manage competing priorities, and lead continuous improvement initiatives.
  • Knowledge of pharmaceutical manufacturing, USP <797>, FDA regulations (21 CFR Parts 210 and 211), and ICH regulations.
  • Proficiency with computer software, particularly SharePoint.
  • ASQ CQA, CMQ/OE, or equivalent certification preferred.

Benefits

  • Medical, dental, and vision coverage.
  • Paid time off.
  • 401(k) matching.
  • Wellness perks, including IV therapy.
  • Compounded medications benefit.
  • Comprehensive benefits supporting health, well-being, and future.

Interested in this position?

Apply directly on the company website

Apply Now

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