Quality Compliance Engineer

Pfizer Pfizer · Pharma · MI

This role supports the Quality Organization by ensuring compliance with regulatory requirements, company quality systems, and cGMP. It focuses on continuous improvement, project leadership, and cross-functional partnerships to enhance compliance, efficiency, and inspection readiness in a pharmaceutical manufacturing environment.

What you'd actually do

  1. Lead and support continuous improvement initiatives focused on strengthening quality systems, reducing repeat deviations, and improving right‑first‑time execution.
  2. Apply root cause analysis tools (e.g., 5 Whys, Fishbone, data trending) to identify systemic issues and drive sustainable solutions.
  3. Partner with cross‑functional teams to simplify processes, improve documentation quality, and enhance compliance efficiency.
  4. Support development and monitoring of quality metrics to identify trends, risks, and opportunities for improvement.
  5. Provide quality oversight and guidance for engineering activities such as equipment qualification, process validation, and facility or utility changes.

Skills

Required

  • Bachelor's degree with at least 4 years of experience; OR Master's degree with at least 2 years of experience; OR PhD with 0+ years of experience; OR Associate's degree with 8 years of experience; OR High school diploma (or equivalent) and 10 years of relevant experience.
  • Experience in Quality Assurance, Quality Compliance, or Engineering support roles.
  • Experience leading continuous improvement or remediation initiatives.
  • Familiarity with root cause analysis, risk management, and quality metrics.
  • Experience supporting regulatory inspections and audits.
  • Knowledge of electronic quality management systems (eQMS).

Nice to have

  • Continuous improvement mindset.
  • Project planning and execution.
  • Regulatory and compliance expertise.
  • Problem solving and data‑driven decision making.
  • Cross‑functional collaboration and influence.
  • Attention to detail with a focus on sustainability and effectiveness.

What the JD emphasized

  • cGMP
  • regulatory requirements
  • quality systems
  • root cause analysis
  • risk management
  • regulatory inspections and audits