Manager/Senior Manager, QA Operations

About this role

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Manager/Senior Manager, QA Operations based in the United States.

This role offers an opportunity to strengthen quality assurance operations within a growing biopharmaceutical environment focused on advancing treatments for serious neurological and psychiatric conditions. You will oversee GMP compliance across external manufacturing and service partners, helping ensure the quality, safety, and reliability of clinical and commercial products. Working closely with internal teams and contract development and manufacturing organizations (CDMOs), you will drive quality improvements, maintain inspection readiness, and support effective quality management systems. The position combines hands-on quality oversight with cross-functional collaboration, supplier relationship management, and team development. It is well suited to an experienced pharmaceutical quality professional who enjoys solving complex challenges, improving processes, and working in a dynamic, fast-paced setting. This is a hybrid on-site role based in New York City, with a requirement to work on-site at least three days per week.

### Accountabilities

• Support the development and implementation of corporate quality management systems that meet the needs of clinical-stage research and development programs as well as commercial operations.
• Partner with Quality Systems and Compliance teams to promote continuous improvement and advance quality improvement initiatives across the organization.
• Develop and monitor key performance indicators (KPIs) to evaluate contract manufacturing organization (CMO) performance, identify trends, and recommend data-driven operational improvements.
• Oversee QA Operations activities, including the review and approval of GMP documentation such as standard operating procedures (SOPs), batch records, validation protocols, technical reports, sp...