QA Operations Manager

About the company

• Clinical-stage biopharmaceutical company focused on advancing treatments for serious neurological and psychiatric conditions.

Responsibilities

• Support the development and implementation of corporate quality management systems for clinical-stage R&D and commercial operations.
• Partner with Quality Systems and Compliance teams to promote continuous improvement.
• Develop and monitor KPIs to evaluate CMO performance and recommend data-driven improvements.
• Oversee QA Operations activities, including review and approval of GMP documentation (SOPs, batch records, validation protocols, technical reports, specifications, deviations, CAPAs, change controls, APQRs).
• Identify and resolve compliance gaps, ensuring inspection readiness.
• Act as primary quality liaison between the organization and external suppliers (CDMOs, GMP service providers).
• Serve as escalation point for supplier quality issues and communicate risks to senior management.
• Collaborate with cross-functional teams to resolve quality issues and implement process improvements.
• Develop, review, and revise SOPs, work instructions, and controlled quality documents.
• Build and support a high-performing QA Operations team through coaching and mentorship.
• Participate in supplier audits and site visits.

Requirements

• Bachelor of Science degree, ideally in a scientific discipline.
• At least 6 years of experience in pharmaceutical Quality Assurance, including 3+ years overseeing contract operations.
• At least 1 year of experience managing or supervising a QA team preferred.
• Experience working with CDMOs and managing external partner relationships preferred.
• Strong knowledge of API and drug product manufacturing processes, particularly oral solid dosage forms.
• Comprehensive understanding of FDA, EEA, and Health Canada regulations, as well as ISO standards.
• Experience developing and implementing quality policies and procedures, conducting audits, and leading cross-functional teams.
• Excellent attention to detail, organizational skills, and ability to manage multiple priorities.
• Strong written and verbal communication, interpersonal, and negotiation skills.
• Ability to work in a fast-paced, evolving environment.
• Willingness to travel domestically and internationally up to 20%.
• Ability to work on-site in New York City on Mondays, Tuesdays, and Thursdays.

Conditions

• Salary range: $125,000–$140,000, with final offer determined by experience, qualifications, internal equity, and location.
• Annual bonus opportunity.
• Significant equity compensation.
• Competitive employee benefits package.
• Hybrid work arrangement with a minimum of three on-site days per week in New York City.