Company Overview
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.
Position Overview
The Director / Associate Director, Supplier Quality and Audits supports the Head of GMP Quality Compliance in building and continuously improving Immunome’s Supplier Quality Compliance and Audit Program.
This role leads supplier audit management, vendor governance, compliance monitoring, risk management, quality agreements, CAPA management, and inspection readiness for GxP suppliers and service providers, including CDMOs, CROs, contract laboratories, consultants, and other outsourced partners. It ensures supplier compliance and audit processes are risk-based, inspection-ready, and aligned with regulatory requirements and Immunome’s Quality Management System, while maintaining an effective audit program and governance of outsourced GxP activities.
As a virtual biotechnology company, Immunome retains ultimate responsibility for the quality and compliance of outsourced operations, and this role is a key partner in ensuring audit effectiveness, governance, and inspection readiness across the product lifecycle. This role partners closely with Quality Operations, which manages day-to-day supplier oversight, while this position provides independent compliance oversight through risk assessments, audits, governance, and remediation follow-up.
Responsibilities
- Support development and continuous improvement of Immunome’s GxP Supplier Quality and Vendor Management Program.
- Lead supplier qualification, risk classification, onboarding, and ongoing monitoring of GxP vendors and service providers.
- Maintain supplier quality records, risk evaluations, audit reports, and performance metrics.
- Support quality oversight of CDMOs, CROs, labs, consultants, and other outsourced service providers.
- Partner with stakeholders to clearly define and maintain vendor responsibilities and compliance expectations.
- Lead negotiation and lifecycle management of quality agreements.
- Plan and conduct supplier audits and follow-up, including responses, CAPAs, and effectiveness checks.
- Support inspection readiness for outsourced GxP operations, including regulatory and internal audit preparation.
- Monitor supplier quality performance, including deviations, CAPAs, complaints, audit findings, and service-level trends.
- Identify, escalate, and support remediation of supplier quality and compliance risks.
- Support cross-functional vendor governance meetings and document decisions, actions, and follow-up commitments.
- Develop and maintain supplier quality procedures, Quality Agreement templates, and related trackers and tools aligned with Immunome’s Quality Management System and regulatory expectations.
- Support continuous improvement of supplier quality, oversight, audit effectiveness, and inspection readiness.
Qualifications
- Bachelor’s degree in a scientific, technical, or related field; advanced degree preferred.
- 8+ years of biopharmaceutical industry experience, including direct oversight of third parties performing GxP activities, cGMP manufacturing, testing, or clinical operations, or equivalent experience.
- Demonstrated experience performing and managing supplier qualification and supplier audit programs.
- Experience supporting virtual, outsourced, or external manufacturing and service provider models preferred.
- Ability to travel domestically and internationally up to 20%, with occasional evening/weekend commitment to support audits and inspections.
- Professional certifications (e.g., ASQ CQA, CMQ/OE, RQAP, ISO 9001/13485 Lead Auditor, RAC) or equivalent quality/auditing/regulatory certifications are highly desirable.
Knowledge and Skills
- Strong knowledge of Supplier Quality Management, GxP auditing, Quality Systems, and regulatory compliance within the biotechnology or pharmaceutical industry.
- Experience managing supplier qualification, governance, quality agreements, risk assessments, and oversight of CDMOs, CROs, labs, and other GxP service providers.
- Demonstrated experience conducting supplier audits, managing audit programs, supporting regulatory inspections, CAPA management, and inspection readiness activities.
- Proven Lead Auditor experience with strong knowledge of FDA, EU, ICH, and applicable GxP regulations.
- Strong understanding of cGMP manufacturing, quality assurance/control, validation, and outsourced pharmaceutical operations.
- Experience developing audit schedules, audit plans, audit reports, and auditor training programs.
- Excellent organizational, communication, collaboration, negotiation, analytical, and problem-solving skills.
- Ability to manage multiple priorities in a fast-paced environment and adapt effectively to changing business needs.
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
E-Verify
Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).