QA Auditor II

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

Role Overview

An opportunity has arisen for a Third Party Quality Lead to support the Quality R&D Third Party organization. The worker will provide quality oversight for external third parties supporting GMP manufacture of active pharmaceutical ingredient (API), cell banking (CB), drug substance (DS), and drug product (DP) for R&D programs.

The successful candidate will play a key role in ensuring that contracted services and associated batch documentation meet applicable GMP, regulatory, quality, and quality agreement requirements. The role also provides the opportunity to apply third-party quality management expertise in a cross-functional R&D environment.

Key Responsibilities

Responsibilities include some of the following:

• Act as the primary day-to-day quality contact for assigned third parties and projects, working with internal stakeholders involved in activities contracted to those third parties.
• Monitor and support management of third-party quality performance and compliance with applicable standards, quality requirements, current Good Manufacturing Practice (cGMP), regulatory requirements, and quality agreements.
• Coordinate and support quality governance meetings with assigned third parties, including preparation of quality performance information, documentation of actions, and follow-up to closure.
• Draft, coordinate, review, maintain, and support approval of quality agreements and related quality documentation, as applicable.
• Review and assess third-party quality management system records, including deviations, complaints, change controls, corrective and preventive actions (CAPAs), investigations, and validation-related documentation, and ensure timely follow-up in accordance with cGMP and quality agreements.
• Identify, assess, document, communicate, mitigate, and mitigate quality issues and risks through the appropriate quality governance pathways.
• Review and approve, or provide quality recommendations on, documentation required to support batch disposition/release activities within the scope of the engagement and applicable authorization.
• Ensure documentation associated with assigned third parties is appropriately reviewed, managed, retained, and archived in accordance with applicable requirements.
• Support third-party selection, qualification, approval, and maintenance of approval status, as appropriate to the assigned scope.
• Participate in third-party audit planning, preparation, execution, response follow-up, and CAPA oversight, as applicable.
• Provide quality support for product or process transfers between client and third parties and for other assigned external manufacturing activities.
• Develop, implement, and improve effective processes and procedures within Quality R&D Third Party, and contribute to cross-functional process improvement initiatives.
• Provide training, education, guidance, and quality advice to business partners and third parties on relevant quality and compliance expectations.

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree in Pharmacy, Science, Engineering, or a related discipline, or an equivalent level of knowledge, understanding, and hands‑on GMP experience in the pharmaceutical environment.
• At least 5 years of pharmaceutical manufacturing and/or quality experience.
• Practical knowledge of cGMP principles and regulatory expectations applicable to pharmaceutical development and manufacturing.
• Experience reviewing or approving GMP manufacturing, laboratory, batch, validation, and/or quality system documentation.
• Experience supporting or leading quality system activities such as deviations, investigations, complaints, change controls, CAPAs, inspections, audits, and root‑cause analysis.
• Experience working with external manufacturing organizations, suppliers, service providers, or other third parties.
• Ability to make sound, risk‑based quality decisions and escal…

Preferred Qualifications

If you have the following characteristics, it would be a plus:

• Experience providing quality oversight for contract manufacturing organizations supporting API, cell banking, drug substance, drug product, or investigational medicinal products.
• Knowledge of the pharmaceutical R&D lifecycle, including clinical development manufacturing and technology transfer.
• Experience with batch documentation review and disposition/release support.
• Experience with quality agreements, third‑party quality governance, quality performance monitoring, and supplier qualification.
• Ability to work independently, manage competing priorities, and consistently deliver agreed outputs in a matrixed and deadline‑driven environment.
• Excellent written and verbal communication skills, with the ability to build effective working relationships and influence internal and external stakeholders.
• Strong attention to detail, analytical thinking, problem identification, and problem‑solving skills.
• Experience working effectively with cross‑functional and geographically dispersed teams and supporting continuous improvement initiatives.

Working Relationships

The worker will collaborate with Quality R&D Third Party, R&D project teams, technical and supply functions, regulatory and clinical supply partners, procurement or third-party management functions, and external manufacturing or service providers, as applicable to the assigned work package.

Pay Rate Range: $30-35/hr