Manager/Senior Manager, QA Operations

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, specifications, deviations, corrective and preventive actions (CAPAs), change controls, and annual product quality reviews (APQRs).

• Identify and resolve compliance gaps, ensuring the quality management system remains inspection-ready and aligned with applicable regulatory requirements.

• Act as the primary quality liaison between the organization and external suppliers, including CDMOs and GMP-related service providers.

• Serve as an escalation point for supplier quality issues involving investigations, nonconformances, deviations, and CAPAs, and communicate significant quality, compliance, and supply risks to senior management.

• Collaborate with internal cross-functional teams and external partners to resolve quality issues, develop corrective action plans, and implement sustainable process improvements.

• Develop, review, and revise SOPs, work instructions, and other controlled quality documents.

• Build and support a high-performing QA Operations team through effective communication, coaching, mentorship, motivation, and performance feedback.

• Participate in supplier audits and site visits as needed to assess compliance and maintain quality standards.

Requirements

• A Bachelor of Science degree is highly preferred, ideally in a scientific discipline.

• At least six years of experience in pharmaceutical Quality Assurance, including three or more years overseeing or managing contract operations.

• At least one year of experience managing or supervising a QA team is preferred.

• Experience working with CDMOs and managing external partner relationships is preferred.

• Strong practical knowledge of active pharmaceutical ingredient (API) and drug product manufacturing processes, particularly oral solid dosage forms.

• Comprehensive understanding of applicable FDA, European Economic Area (EEA), and Health Canada regulations, as well as ISO and other relevant quality standards.

• Demonstrated experience developing and implementing quality policies and procedures, conducting audits, and leading cross-functional teams.

• Excellent attention to detail, organizational skills, and the ability to manage multiple priorities effectively.

• Strong written and verbal communication, interpersonal, and negotiation skills.

• Ability to work effectively in a fast-paced, evolving environment, navigate ambiguity, adapt to change, and contribute to a growing organization.

• Willingness to travel domestically and internationally up to 20% as business needs require.

• Ability to work on-site in New York City on Mondays, Tuesdays, and Thursdays. Fully remote arrangements are not available.

Benefits

• Salary range:$125,000–$140,000, with the 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.