Description
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.
#LI-Remote
Similar jobs
Est. 183,500 USD
Syndax Pharmaceuticals is looking for a Senior Manager, GMP Investigational Quality At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuti…
Est. 120,000 USD
Syndax Pharmaceuticals is looking for a Contractor - Strategic Outsourcing Lead At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals…
Est. 110,000 USD
Syndax Pharmaceuticals is looking for a Contractor – Senior Drug Safety Specialist At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceutic…
Est. 222,500 USD
Syndax Pharmaceuticals is looking for a Director, Clinical Supply Chain 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 co…
Est. 120,000 USD
Syndax Pharmaceuticals is looking for a Contractor, Clinical Trial Manager 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…
Est. 207,500 USD
Syndax Pharmaceuticals is looking for an Associate Director, Regulatory Strategy At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceutical…
Est. 120,000 USD
Syndax Pharmaceuticals is looking for a Contractor, Medical Strategy & Field Scientific Engagement (Pulmonary/IPF) At Syndax, we are determined to realize a future in which people with cancer live longer and better t…
Est. 275,000 USD
Syndax Pharmaceuticals is looking for a Director/Senior Director, Bioanalysis At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals i…
Est. 120,000 USD
Syndax Pharmaceuticals is looking for a Contractor – Principal Statistical Programmer At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceu…
Est. 240,000 USD
Syndax Pharmaceuticals is looking for a Strategic Account Manager - Michiana At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is…
Est. 385,000 USD
Syndax Pharmaceuticals is looking for an Executive Director, Asset Strategy Lead and Clinical Lead, Early Development At Syndax, we are determined to realize a future in which people with cancer live longer and better th…
Est. 400,000 USD
Syndax Pharmaceuticals is looking for a Vice President, Asset Strategy Lead, Revumenib At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmace…
Est. 295,000 USD
Syndax Pharmaceuticals is looking for a Senior Director, Clinical Pharmacology At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals…
Est. 120,000 USD
COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, w…
COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, w…
Est. 120,000 USD
COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, w…
COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, w…
Est. 209,600 USD
Description of Role The Director, Quality Control (contractor) will provide leadership and oversight for analytical testing, stability programs, specification management, and quality control activities supporting clinica…
COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, w…
Est. 270,000 USD
Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop diffe…
Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve…
Est. 161,500 USD
COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, w…
Est. 210,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 187,500 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 120,000 USD
COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, w…
Est. 153,000 USD
Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitmen…
Est. 55,000 USD
Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medic…
Est. 183,000 USD
Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitmen…
Est. 163,550 USD
About Acadia Pharmaceuticals Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commerci…
Est. 172,500 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…