Fort CollinsFull TimeHealthcare
Remotely
pharmaceuticalauditscapagmpfdaglpiso 13485gdp
Job Description
📋 Description
- Lead and oversee the Quality Compliance team, managing daily activities, priorities, performance
- Build and maintain a strong culture of quality, compliance, candid communication, continuous
- Manage regulatory, internal, third-party, and customer audits and inspections, including
- Own and maintain the inspection readiness program, including training, readiness assessments
- Serve as a key representative during regulatory inspections, including front-room and back-room
- Lead internal audit planning and execution using risk- and budget-based approaches, ensuring
🎯 Requirements
- Bachelor’s degree in a scientific, engineering, or technical discipline.
- At least 8 years of experience in Quality and/or Compliance within the pharmaceutical industry.
- At least 5 years of experience managing inspections and audits, including regulatory and/or
- At least 3 years of experience leading or managing quality system elements, such as
- Strong knowledge of FDA and international regulatory requirements applicable to pharmaceutical
- Working knowledge of drug or device cGMP requirements and ISO 13485, along with familiarity with
🎁 Benefits
- Annual salary range of $100,000–$115,000, depending on experience and qualifications.
- Eligibility for a performance-based bonus.
- Comprehensive employee benefits package.
- Market-based compensation and commitment to equitable and fair pay practices.
- Primarily on-site work environment in Fort Collins, Colorado.
- Opportunities to lead a high-impact Quality Compliance function within a highly regulated
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