Pharma Quality Manufacturing SME

Benefits

Additional Information

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. 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 #LI-EB3 We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***