Senior Manager, Quality Operations

ALCAMI

Pepperell, MA, US
Base: $110,000 – $160,000 py; bonus/equity: not sp...
On-site
10+ years related experience required
7+ years supervisory experience required
Expert knowledge of cgmp and 21 cfr 210/211
Alcami is seeking a Senior Manager of Quality Operations to oversee quality standards in a fast-paced environment, ensuring compliance with regulatory requirements. The role requires extensive experience in quality assurance, specifically within the pharmaceutical industry, and involves collaboration with various teams to drive continuous improvement

Job Summary

  • The Senior Manager leads the site Quality team in reviewing documents, data, protocols, and managing corrective actions within a fast-paced pharmaceutical environment.
  • This role ensures strict compliance with GMP, ISO17025, and 21 CFR regulations while collaborating with corporate functions to maintain robust Quality Management Systems.
  • Alcami offers a competitive salary range of $110,000 – $160,000 along with comprehensive benefits including medical, dental, vision, and immediate 401(k) vesting.

Matching Summary

Match Score: 85

Alcami is seeking a Senior Manager of Quality Operations to oversee quality standards in a fast-paced environment, ensuring compliance with regulatory requirements. The role requires extensive experience in quality assurance, specifically within the pharmaceutical industry, and involves collaboration with various teams to drive continuous improvement.

Salary

Base: $110,000 – $160,000 per year; Bonus/Equity: Not specified; Benefits: Medical, dental, vision, 401(k) with match and immediate vesting, tuition reimbursement

Skills & Requirements

Must-have

  • 10+ years related experience required
  • 7+ years supervisory experience required
  • Expert knowledge of cGMP and 21 CFR 210/211
  • ISO17025 compliance oversight
  • Root cause analysis for investigations
  • CAPA implementation and closure
  • Regulatory inspection support

Nice-to-have

  • Prior CDMO industry experience preferred
  • Experience with aseptic processing
  • Auditing skills preferred
  • Strategic planning capabilities
  • Client interaction and audit management

Key Requirements

  • Bachelor's degree minimum
  • 10+ years of related experience
  • 7+ years of supervisory experience
  • Prior GMP experience required
  • Knowledge of 21 CFR Part 210 and 211

Work Rights

Not specified

Tailored Resume

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