Pharma Quality Manufacturing SME [Remote]

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.

Requirements

• 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.

Benefits

• 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.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.