Pharma Quality Manufacturing SME
About The Position
For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. 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.
Requirements
- 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.
Responsibilities
- Embed commercial-ready quality behaviors, systems, and continuous improvement practices.
- Maintain quality program momentum and consistency during leadership transition.
- Coach and mentor staff in critical thinking, deviation management, and quality decision-making.
- Strengthen documentation standards and ensure inspection readiness.
- Establish a strong quality foundation for incoming leaders to build upon.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
