Senior Quality Lead, Contract Manufacturing

Nephron Pharmaceuticals Corporation; West Columbia (SC); On-site; USD 90,000 - 120,000; Full time

Job summary

Nephron Pharmaceuticals Corporation is seeking a Senior Quality Specialist – Contract Manufacturing to oversee quality and regulatory activities for CMOs. You will coordinate cross-functional projects, manage investigations, and ensure timely product releases with stringent cGMP compliance.

In this role you will liaise with internal teams and external customers, support audits and CAPA, and drive continuous improvement across quality systems.

Qualifications

• Bachelor’s degree in a relevant scientific or technical field is required.
• 3+ years of experience in pharmaceutical manufacturing, quality, or related discipline.
• Strong knowledge of cGMP and applicable FDA quality regulations.
• Experience supporting regulatory inspections, audits, CAPA, and change controls.
• Excellent written and verbal communication and documentation skills.

Responsibilities

• Provide quality oversight and regulatory support for contract manufacturing activities.
• Coordinate cross-functional projects from new product introductions to product releases.
• Serve as liaison between internal teams, customers, CMOs, and stakeholders.
• Support audits, inspections, deviations, investigations, CAPA, and change controls.
• Maintain QMS records and drive continuous improvement in processes.

Skills

Quality assurance

cGMP knowledge

FDA regulations

Project management

Cross-functional coordination

Documentation review

Attention to detail

Regulatory compliance

Education

Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, Engineering, Life Sciences, or related

Job description

Nephron Pharmaceuticals Corporation is seeking a Senior Quality Specialist – Contract Manufacturing to oversee quality and regulatory activities for CMOs. You will coordinate cross-functional projects, manage investigations, and ensure timely product releases with stringent cGMP compliance.

In this role you will liaise with internal teams and external customers, support audits and CAPA, and drive continuous improvement across quality systems.