Syndax Pharmaceuticals is looking for a Contractor – Supplier Quality Management
At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies.
The Role:
The Supplier Quality Management (SQM) Director will support the Quality Assurance organization in ensuring the qualification, oversight, and ongoing management of GxP service providers, suppliers, contract laboratories, distribution partners, and other outsourced vendors supporting operations.
This role will work cross-functionally with Quality, Supply Chain, Regulatory, Clinical Operations, Pharmacovigilance, IT and external partners to maintain a compliant and effective supplier management program. The director will play a key role in supporting supplier qualification activities associated with business growth initiatives, supply chain diversification, third-party logistics transitions, and the onboarding of new service providers.
This position is a 30-hour-per-week remote contract role.
Key Responsibilities:
Supplier Qualification and Oversight
- Lead and support qualification activities for new and existing GxP suppliers and service providers.
- Conduct supplier risk assessments and determine qualification requirements based on supplier criticality and risk.
- Oversee vendors from a compliance perspective and ensure actions are coordinated to support additional oversight as necessary.
- Review supplier qualification questionnaires, quality documentation, certifications, and supporting records.
- Coordinate supplier audits, remote assessments, and qualification reviews.
- Prepare qualification reports and recommendations for approval.
Supplier Lifecycle Management
- Maintain supplier files and qualification records in accordance with company procedures.
- Monitor supplier qualification status and ensure timely completion of periodic reviews and requalification activities.
- Support supplier performance monitoring and quality metrics reporting for Quality Management Review (QMR).
- Follow up on supplier quality events, corrective actions, and identified risks.
Quality Agreements
- Draft, review, negotiate, and maintain Quality Technical Agreements (QTAs) and other supplier quality documents.
- Partner with internal stakeholders and suppliers to ensure quality responsibilities are clearly defined and documented.
Compliance and Inspection Readiness
- Support inspection readiness activities related to supplier oversight and vendor management programs.
- Ensure supplier management processes remain compliant with applicable FDA, EMA, ICH, and GxP requirements.
- Participate in internal audits, regulatory inspections, and supplier-related quality investigations as needed.
Cross-Functional Collaboration
- Collaborate with Supply Chain, Technical Operations, Clinical Supply, Regulatory Affairs, Pharmacovigilance, and other stakeholders to support business objectives.
- Provide supplier quality expertise for new business initiatives, vendor selection activities, and strategic sourcing projects.
- Support implementation of process improvements and continuous improvement initiatives within the Supplier Quality Management program.
Desired Experience/Education and Personal Attributes:
- Minimum 5-8 years of experience in Quality Assurance within the pharmaceutical, biotechnology, or related GxP-regulated industry.
- Demonstrated experience in supplier qualification, supplier auditing, vendor oversight, and quality agreement management.
- Experience supporting contract manufacturers, contract laboratories, distribution providers, and GxP service vendors.
- Working knowledge of FDA, EU GMP, ICH, and GxP regulations and expectations.
- Experience operating within a virtual or outsourced pharmaceutical business model.
- Experience supporting supply chain expansion, dual-sourcing initiatives, and logistics provider transitions.
- Lead Auditor certification or equivalent supplier auditing experience.
- Experience with electronic Quality Management Systems (eQMS) and supplier management platforms (e.g. Veeva).
- Strong understanding of supplier quality management principles and risk-based decision making.
- Excellent technical writing and documentation skills.
- Ability to manage multiple projects and competing priorities.
- Strong communication and stakeholder management skills.
- Ability to work independently while collaborating effectively in a cross-functional environment.
- Detail-oriented with a strong commitment to compliance and quality excellence.
Location: While our corporate headquarters are located in New York City, this position is open to candidates from any location with a preference for east coast locations.
About Syndax:
Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of the Company’s pipeline include a menin inhibitor for R/R acute leukemia and a monoclonal antibody that blocks the CSF-1 receptor for chronic graft-versus-host disease. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com/ or follow the Company on X and LinkedIn.
Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
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