Job Description
Team: Others
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Pharma Quality Manufacturing SME in the United States.
This is a short-term, high-impact quality consulting role embedded within a pharmaceutical manufacturing environment, focused on strengthening operational excellence and inspection readiness. The position plays a critical role in reinforcing quality systems during a leadership transition, ensuring continuity, consistency, and compliance across key manufacturing and quality processes. You will work closely with cross-functional teams including Manufacturing, Process Development, Validation, and MS&T to elevate documentation standards and embed risk-based quality principles. The role emphasizes hands-on coaching, practical quality system improvements, and the reinforcement of commercial-ready behaviors across the site. Operating onsite, you will serve as a trusted subject matter expert driving clarity, structure, and discipline in quality execution. This is a highly collaborative role where your expertise directly supports regulatory readiness and long-term operational stability.
Accountabilities
- Partner with Quality leadership to identify and prioritize immediate operational and procedural improvement needs across the site.
- Review, refine, and enhance critical quality records including deviations, CAPAs, validation documents, and batch records to ensure commercial-grade standards.
- Support the embedding of risk-based thinking by facilitating coaching sessions focused on quality decision-making and root-cause analysis.
- Standardize documentation practices, templates, and workflows to improve consistency, clarity, and regulatory alignment.
- Strengthen inspection readiness by improving documentation quality and ensuring robust quality system execution.
- Document key processes, metrics, and lessons learned to support leadership transition and continuity planning.
- Collaborate with cross-functional teams to ensure alignment between manufacturing operations and quality system expectations.
- Promote continuous improvement practices and reinforce commercial-ready quality behaviors across the organization.
- Extensive experience in pharmaceutical manufacturing quality, with strong expertise in GMP environments.
- Proven background in quality systems, including deviations, CAPA management, validation documentation, and batch record review.
- Strong understanding of risk-based quality principles and their application in manufacturing and compliance settings.
- Experience working across cross-functional teams such as Manufacturing, MS&T, Process Development, and Validation.
- Demonstrated ability to coach and mentor teams in quality decision-making, critical thinking, and compliance best practices.
- Strong documentation skills with the ability to standardize and improve technical and operational records.
- Experience supporting inspection readiness or regulatory inspection preparation is highly preferred.
- Ability to work onsite in a fast-paced, highly collaborative environment in Rockville, MD.
- Strong communication, influence, and stakeholder management skills.
- Ability to operate independently in a focused, short-term consulting engagement.
- Full-time contract opportunity (7 weeks) with immediate start potential.
- Onsite engagement in a regulated, high-impact pharmaceutical manufacturing environment.
- Opportunity to directly influence quality system maturity and inspection readiness.
- Collaborative cross-functional work environment with exposure to multiple technical disciplines.
- Chance to contribute expertise during a critical organizational transition period.
- Hands-on leadership impact without formal managerial responsibility.
- Exposure to commercial readiness and quality transformation initiatives.
Requirements
Benefits
Explore More
Date Posted
06/04/2026
Views
0
Similar Jobs
Senior Software Engineer, Developer Experience - Jobgether
Views in the last 30 days - 0
View Details