Quality Remediation Project Lead

Job Description

Job Description

Workforce Genetics is assembling a high-impact, 5-person contingent quality team to support a premier pharmaceutical manufacturing facility in the Greater Baltimore Area. The site is executing an intensive quality remediation project to address an active backlog of open investigations, deviations, and CAPAs. The primary immediate objective is an aggressive clearance of high-priority deviations.

We are actively recruiting 1 Project Lead for this dedicated, 6+ month on-site project.

Responsibilities:

• Scope: Serves as a hands-on manager and project lead who tracks daily completion metrics, identifies systemic workflow blockers, updates operational leadership, and coordinates directly with global QA teams while actively assisting in writing deviations.

General Candidate Profile & Technical Requirements

• Experience: Minimum 5–6 years within biopharma/GMP compliance environments, specifically showing history managing quality, compliance or manufacturing writing teams, efficient and high quality project delivery.
• Core Competency:
• Proven expertise in systematic root-cause analysis (RCA) methodologies and standard cGMP technical writing.
• Strong preference for professionals with eclectic experience across upstream processing, downstream processing, and fill lines. Familiarity with Oral Solid Dose (OSD) manufacturing and visual inspection processes is a significant advantage.
• A formal academic degree is not strictly required; technical mastery, an ability to write cleanly under tight compliance timelines, and a strong history on the manufacturing floor are the primary drivers for selection.

Core Hours: Mon–Fri, 8AM–5PM (Standard Business Hours)