What are the responsibilities and job description for the Quality Manufacturing SME (Pharma) position at ProPharma?
The embedded resource will work closely with the Quality organization and cross-functional groups (i.e. Manufacturing, Process Development, Validation, and MS&T) to drive commercial readiness, improve documentation quality, and embed risk-based quality principles throughout the site.
Objectives
1. Embed commercial-ready quality behaviors, systems, and continuous improvement practices.
2. Maintain quality program momentum and consistency during leadership transition.
3. Coach and mentor staff in critical thinking, deviation management, and quality decision-making.
4. Strengthen documentation standards and ensure inspection readiness.
5. Establish a strong quality foundation for incoming leaders to build upon.
Scope of Work
Collaborate with Quality leadership to identify immediate operational and procedural priorities.
• Review and enhance key records (deviations, CAPAs, validation documents, batch records, etc.) to commercial standards.
• Facilitate coaching sessions focused on risk-based thinking and decision justification.
• Standardize templates, workflows, and review practices to improve clarity and consistency.
• Support leadership readiness by documenting processes, metrics, and lessons learned to aid transition.
Out of Scope
The embedded resource will not apply Quality signatory authority in quality systems.
The embedded resource will not manage personnel in any Quality or site systems.
*7 week contract opportunity (full-time weekly hours)
*Onsite in Rockville, MD