Director of External Research and Development – Cardiovascular and Metabolic Therapeutics
Amgen
Director, Global Device Quality
Viatris
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $112,000 - $236,000 per year
Job Level
Lead
About the role
- Provide leadership and drive continuous improvements in quality system practices
- Align with other top-level managers in the development and establishment of corporate-wide Quality initiatives
- Function as a change leader within the Quality organization
- Serve as a subject matter expert regarding best practices in Quality Management Systems
- Evaluate, implement, and execute systems for standardizing compliant practices
- Provide global oversight of standardized systems and perform "in use" verification
- Participate in activities in support of global inspection preparedness
- Interact with Health Authorities and Notified Bodies
- Collaborate with quality colleagues and other departments during integration activities
- Monitor regulatory trends and identify industry best practices
- Develop training strategies and content
Requirements
- Minimum of a Bachelor's degree (or equivalent) in a science related discipline
- Minimum of 10 years of experience in an analytical, quality, or manufacturing environment
- Knowledge of national, international, and supranational cGMP regulations
- Familiarity with all concepts related to assigned quality systems
- Must be articulate in both written and oral communications
- Must have computer skills with working knowledge of Microsoft Office including Word, Excel, and Outlook
- Quality certifications preferred
Benefits
- Competitive salaries
- Health insurance
- Paid time off
- Flexible work arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality Management SystemscGMP regulationsanalytical skillsquality systemscompliance practicestraining developmentinspection preparednesschange managementprocess improvementstandardization
Soft skills
leadershipcommunicationcollaborationinterpersonal skillschange leadershiparticulationorganizational skillsproblem-solvingstrategic thinkingadaptability
Certifications
Quality certifications
