Associate Director, Quality Assurance
MSD
full-time
Posted on:
Location Type: Hybrid
Location: Pennsylvania • United States
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Salary
💰 $142,400 - $224,100 per year
Job Level
About the role
- The incumbent will be part of the Microbiological Quality & Sterility Assurance organization
- Provide subject matter expertise for microbiology and/or virology related topics in biologic, vaccine sterile, non-sterile manufacturing and/or testing laboratories
- Support the development, deployment and maintenance of multiple divisional quality standards and divisional policies
- Support divisional projects across internal and external sites
- Deliver support for regulatory inspections and responses
- Develop, author, and maintain the divisional quality standards
- Assist manufacturing sites and project teams with project strategy and regulatory interactions
- Champion company initiatives and projects to improve compliance and consistency
Requirements
- Minimum 8 years in pharmaceutical, biopharmaceutical, vaccine or medical device industry
- Technical problem-solving abilities
- Strong communications, planning and collaboration/negotiation skills
- Technical writing proficiency
- Knowledge of international GMPs and Quality Management requirements of various regulatory agencies (e.g. US FDA, EMEA, TGA, PMDA, etc.) as well as USP compendia, EU compendia and ISO industry standards
- Ability and willingness to travel to the manufacturing sites in USA, Europe, Latin America and /or Asia for up to 20% of the time
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
microbiologyvirologytechnical writingGMPQuality Managementregulatory complianceproject strategyquality standards developmentbiologic manufacturingvaccine manufacturing
Soft skills
technical problem-solvingcommunicationplanningcollaborationnegotiation