Contractor – Director, Supplier Quality Management

Syndax Pharmaceuticals•New York, NY

5h•Remote

About The Position

Syndax Pharmaceuticals is seeking a Contractor – Director, Supplier Quality Management to support the Quality Assurance organization. This role is responsible for ensuring the qualification, oversight, and ongoing management of GxP service providers, suppliers, contract laboratories, distribution partners, and other outsourced vendors supporting operations. The position will collaborate 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 be instrumental in supporting supplier qualification activities related to business growth, supply chain diversification, third-party logistics transitions, and onboarding new service providers.

Requirements

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.

Responsibilities

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.
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.
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.
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.
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.