Head of Quality Assurance at Syndax Pharmaceuticals

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 clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies.

The Role:

The Head of QA will develop and lead a Quality organization for all GxP areas. This role will be accountable to ensure compliance with regulatory standards, driving quality initiatives and supporting the organization's strategic goals. This role will partner closely with internal and external stakeholders, including regulatory agencies, suppliers, and manufacturing partners, to ensure the seamless and compliant launch and sustainment of Syndax’s commercial product portfolio.

Key Responsibilities:

Commercial QA Strategy:

Define and execute a robust quality assurance strategy tailored for commercial operations, aligning with Syndax’s commercialization goals and global regulatory standards.

Quality Systems Implementation and Optimization:

Oversee the establishment, maintenance, and continuous improvement of commercial-stage quality systems. Drive continuous improvement initiatives and projects to improve processes and the QMS.

Regulatory Compliance and Inspection Readiness:

Serve as the quality lead in interactions with regulatory authority inspectorates (FDA, EMA, etc.) and other external auditors and ensure audit readiness to support both planned and unplanned inspections.

Cross-Functional Collaboration:

Work closely with Manufacturing, Supply Chain, Regulatory Affairs, Clinical Operations, Pharmacovigilance, Medical Affairs, and other key teams to embed quality into each phase of the development and commercialization process, ensuring all processes support consistent quality and compliance standards.

Product Quality Lifecycle Management:

Develop robust quality management systems to support the entire product lifecycle from pre-clinical to maturity.

Supplier and Partner Quality Management:

Develop and oversee supplier qualification and audit programs to ensure that all third-party manufacturers, packagers, and distributors consistently meet Syndax’s quality standards.

Risk Management and Issue Resolution:

Lead risk assessments, implement mitigation strategies, and manage quality-related issues in the commercial supply chain to minimize risk to patients and business operations.

Team Development and Leadership:

Mentor and lead a high-performing QA team to ensure a culture of quality across the organization. Provide guidance, training, and development to keep the team up to date with evolving quality and regulatory standards.

Quality Metrics, Reporting, and Continuous Improvement:

Develop and monitor key quality performance indicators (KPIs) specific to commercialization. Regularly report quality performance to leadership, ensuring ongoing assessment and refinement of quality systems and processes.

Desired Experience/Education and Personal Attributes:

Education:

Bachelor’s degree in Life Sciences or a related field; advanced degree desirable but not required.

Experience:

• Minimum of 12 years’ experience in the pharmaceutical or biotech industry in a quality or related role, with 5+ years in a commercial-stage role.
• Experience in oncology or other high-impact therapeutic areas.
• Demonstrated success managing quality and regulatory compliance in a global environment.
• Demonstrated strong GxP knowledge and understanding of relevant global regulatory requirements.
• Demonstrated expertise in developing and leading quality strategies and organization, particularly in the pharmaceutical/biotech commercialization phase.

Operational Excellence:

Experience with implementing and managing GxP quality systems, risk management, and continuous improvement practices in a commercial setting.

Leadership Abilities:

Proven ability to lead and inspire a QA team, fostering a strong quality culture throughout an organization. Ability to work cross-functionally to drive quality initiatives in a collaborative, commercial-focused environment.

Analytical and Problem-Solving Skills:

Strong skills in risk assessment, root cause analysis, and problem-solving, with experience managing complex quality issues in a high-paced, regulated environment.

Communication Skills:

Excellent verbal and written communication skills, with a proven track record of engaging and influencing internal and external stakeholders, including regulatory agencies.

Location:

Syndax has offices in Waltham, MA and New York City.

About Syndax:

Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include Revuforj (revumenib), an FDA-approved menin inhibitor, and Niktimvo (axatilimab-csfr), an FDA-approved monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. 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 (formerly Twitter) 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.