Massachusetts Licensed Compliance Director
Job Summary
Leading enterprise governance and compliance strategies, the full-time Massachusetts Licensed Compliance Director will oversee aseptic and microbial control frameworks while ensuring alignment with regulatory standards across multiple manufacturing environments.
Key Responsibilities
- Own and maintain the enterprise contamination control governance framework, ensuring compliance with standards and regulatory expectations
- Define and implement the enterprise aseptic and microbial control roadmap, including strategic objectives and performance monitoring
- Lead regulatory engagement strategies and provide technical compliance support during inspections and audits
Required Qualifications
- Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline
- 15+ years of experience in the pharmaceutical industry with a focus on microbiology and aseptic processing
- A minimum of 8-10 years in senior leadership roles with enterprise-level accountability
- Demonstrated expertise in global regulatory frameworks relevant to aseptic processing and contamination control
- Proven experience leading regulatory inspections and managing CMO/CDMO quality relationships
Complete Job Description
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