Senior QA Auditor: Third-Party Quality Oversight

Planet Pharma; Collegeville (PA); On-site; USD 41,000 - 48,000; Full time

Job summary

Planet Pharma is seeking a Third Party Quality Lead to support the Quality R&D Third Party organization. The role provides quality oversight for external partners involved in GMP manufacture of API, cell banking, drug substance and drug product for R&D programs.

You will ensure contracted services and batch documentation meet GMP, regulatory, quality, and quality agreement requirements, and you will lead quality governance with external partners across a cross-functional, matrixed environment.

Qualifications

• Bachelor’s degree in Pharmacy, Science, Engineering, or related discipline, or equivalent GMP experience.
• Minimum 5 years of pharmaceutical manufacturing and/or quality experience.
• Practical knowledge of cGMP principles and regulatory expectations for development and manufacturing.
• Experience reviewing GMP manufacturing, lab, batch, validation, or quality system documentation.
• Experience leading quality system activities: deviations, investigations, complaints, change controls, CAPAs, inspections, audits, root-cause analysis.
• Experience with external manufacturing organizations, suppliers, or third parties.

Responsibilities

• Act as the primary day-to-day quality contact for assigned third parties and projects.
• Monitor third-party quality performance and ensure compliance with cGMP and quality agreements.
• Coordinate quality governance meetings, prepare performance information, and follow up on actions.
• Draft, coordinate, review, and maintain quality agreements and related documentation.
• Review third-party QMS records, deviations, CAPAs, investigations, and validation docs.
• Identify and mitigate quality issues and risks through governance pathways.
• Review/approve documentation supporting batch disposition/release within engagement scope.
• Ensure documentation retention and archival in line with requirements.
• Support third-party selection, qualification, approval, and status maintenance.
• Participate in third-party audits, response, and CAPA oversight.
• Provide quality support for product/process transfers and external manufacturing activities.
• Develop and improve processes within Quality R&D Third Party; drive cross-functional improvements.
• Provide training and guidance on quality expectations to partners.

Skills

Quality oversight

cGMP knowledge

Regulatory understanding

Risk-based decisions

Cross-functional collaboration

Vendor management

Audits & CAPA

Education

Bachelor’s degree or equivalent GMP experience

Tools

Quality Management System (QMS)

Job description

Planet Pharma is seeking a Third Party Quality Lead to support the Quality R&D Third Party organization. The role provides quality oversight for external partners involved in GMP manufacture of API, cell banking, drug substance and drug product for R&D programs.

You will ensure contracted services and batch documentation meet GMP, regulatory, quality, and quality agreement requirements, and you will lead quality governance with external partners across a cross-functional, matrixed environment.