Work Location: Bucks County, Pennsylvania

Summary:

Seeking an experienced QA Manager to provide leadership and real-time oversight of sterile manufacturing and packaging operations. This role ensures compliance with cGMP, regulatory requirements, and internal quality standards, while supporting batch execution, documentation accuracy, and inspection readiness.

Responsibilities:

• Direct daily QA activities for sterile injectable manufacturing and packaging, ensuring compliance with aseptic processing standards.
• Maintain a continuous QA presence on the manufacturing floor to support batch operations and critical process controls.
• Review and approve line and room clearances, equipment release, and product changeovers per established procedures.
• Assess and resolve deviations, procedural discrepancies, and aseptic risks during manufacturing operations.
• Oversee in-process inspections, environmental controls, and verification activities to uphold sterile manufacturing standards.
• Coordinate sampling of raw materials, in-process materials, and finished products with Quality Control teams.
• Initiate and approve deviation investigations, root cause analyses, and CAPA related to manufacturing and aseptic processing.
• Support internal audits, regulatory inspections, and ensure timely escalation of critical quality risks and compliance concerns.

Qualifications:

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biology, Engineering, or a related scientific discipline required.
• 7–10 years of progressive Quality Assurance experience in a cGMP-regulated sterile injectable pharmaceutical manufacturing environment required.
• Demonstrated on-floor QA oversight experience in aseptic manufacturing operations required.
• Prior experience leading or managing QA Operations or QA Floor teams in a sterile manufacturing environment required.
• Experience supporting regulatory inspections in a sterile facility strongly preferred.
• Advanced knowledge of cGMP regulations for sterile injectable manufacturing (21 CFR Parts 210/211).
• Strong understanding of aseptic processing, sterility assurance, environmental monitoring, and contamination control.
• Ability to provide decisive, real-time QA judgment during manufacturing operations.
• Experience with deviations, investigations, CAPA, batch disposition, and inspection readiness.
• Understanding of data integrity principles (ALCOA+) and good documentation practices.
• Proven leadership in fast-paced, regulated manufacturing environments.
• Effective written and verbal communication skills for cross-functional and executive interactions.
• Proficiency with Microsoft Office and electronic quality management systems (eQMS).
• Stable work history preferred.

Published Category: Quality & Validation