Senior Quality Assurance Executive

6 days ago


Waltham, Massachusetts, United States Lifelancer Full time
Revolutionize Cancer Treatment as a Senior Quality Assurance Executive

Job Title: Senior Quality Assurance Executive

Location: Waltham, MA or New York City

Estimated Salary:$200,000 - $250,000 per annum

About the Role

Syndax Pharmaceuticals is seeking an exceptional Senior Quality Assurance Executive to spearhead its commercial-stage quality organization. This role will be responsible for ensuring compliance with regulatory standards, driving quality initiatives, and supporting strategic goals.

The successful candidate will partner closely with internal and external stakeholders, including regulatory agencies, suppliers, and manufacturing partners, to ensure seamless and compliant launch and sustainment of Syndax's commercial product portfolio.

Duties and Responsibilities
  1. Commercial QA Strategy: Develop and execute a robust quality assurance strategy tailored for commercial operations, aligning with Syndax's commercialization goals and global regulatory standards.
  2. 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.
  3. Regulatory Compliance and Inspection Readiness: Serve as the quality lead in interactions with regulatory authority inspectorates (FDA, EMA, etc.) and other external auditors, ensuring audit readiness to support both planned and unplanned inspections.
  4. 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.
  5. Product Quality Lifecycle Management: Implement robust quality management systems to support the entire product lifecycle from pre-clinical to maturity.
  6. Supplier and Partner Quality Management: Develop and oversee supplier qualification and audit programs to ensure third-party manufacturers, packagers, and distributors meet Syndax's quality standards.
  7. 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.
  8. Team Development and Leadership: Mentor and lead a high-performing QA team to foster a culture of quality across the organization.
Requirements
  • Education: Bachelor's degree in Life Sciences or a related field; advanced degree desirable but not required.
  • Experience: Minimum 12 years' experience in the pharmaceutical or biotech industry in a quality or related role, with 5+ years in a commercial-stage role.
  • Oncology Expertise: Experience in oncology or other high-impact therapeutic areas.
  • GxP Knowledge: Demonstrated strong GxP knowledge and understanding of relevant global regulatory requirements.
  • Leadership Abilities: Proven ability to lead and inspire a QA team, fostering a strong quality culture throughout an organization.
  • Communication Skills: Excellent verbal and written communication skills, engaging and influencing internal and external stakeholders.
About Lifelancer

Lifelancer is a talent-hiring platform connecting professionals with opportunities in life sciences, pharma, health sciences, healthtech, and IT domains.



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