Senior Manager, Quality Operations

Accountabilities:

In this role, you will support day-to-day Quality Operations while helping establish the systems and partnerships required for commercial pharmaceutical supply. Your main responsibilities will include:

• Batch Review and Release Support: Review executed batch records, Certificates of Analysis (CoAs), Certificates of Compliance (CoCs), laboratory data, stability results, and supporting release documentation. Identify discrepancies and compliance concerns, coordinate resolution with contract development and manufacturing organizations (CDMOs), and support timely batch disposition and release.

• Quality Events and Investigations: Review and triage deviations, investigations, corrective and preventive actions (CAPAs), and out-of-specification (OOS) events from external manufacturing partners. Assess potential quality and compliance risks, monitor resolution timelines, and support appropriate root cause analysis and corrective actions.

• Product Complaints and Risk Management: Participate in complaint investigations and help implement the processes, responsibilities, and documentation required for commercial complaint management. Evaluate potential impacts on product quality and patient safety, identify emerging concerns, and escalate issues appropriately.

• Commercial Quality Readiness: Collaborate with the Senior Director, Quality Operations and Supplier Quality Management, cross-functional stakeholders, and external vendors to implement the processes and controls needed for commercial launch, manufacturing, product release, distribution, and post-approval requirements.

• Serialization and Product Traceability: Work with CDMOs and third-party logistics (3PL) providers to support Drug Supply Chain Security Act (DSCSA) serialization requirements and Electronic Product Code Information Services (EPCIS) data exchange. Verify the accuracy and completeness of traceability data throughout the pharmaceutical supply chain.

• External Partner Management: Serve as a day-to-day Quality Operations contact for CDMOs and the 3PL, coordinating documentation, quality events, release requirements, and distribution issues. Monitor quality trends, support vendor performance reviews and qualification activities, and participate in Person-in-Plant oversight as needed.

• Inspection Readiness and Reporting: Maintain accurate, complete, and inspection-ready documentation. Support Quality Operations metrics, continuous improvement initiatives, and preparation of the Annual Product Review.

Requirements:

The ideal candidate combines strong pharmaceutical GMP expertise with practical experience managing quality activities in an outsourced manufacturing environment. You should be detail-oriented, proactive, and comfortable making risk-based decisions while working in a lean organization. Key qualifications include:

• A bachelor’s degree in life sciences or a related field, or equivalent relevant industry experience.

• At least 7 years of GMP Quality experience in the biotechnology or pharmaceutical industry, ideally covering late-stage clinical development and commercial readiness.

• Hands-on experience reviewing batch records, product release documentation, analytical results, and stability data, with a strong ability to identify discrepancies and ensure documentation accuracy.

• Experience reviewing deviations, investigations, CAPAs, OOS events, or other quality events and assessing their potential impact on product quality, regulatory compliance, and patient safety.

• Experience working with CDMOs or other external manufacturing partners in an outsourced pharmaceutical or biologics environment.

• Understanding of the quality and distribution requirements involved in transitioning from clinical supply to commercial product. Experience with DSCSA serialization, EPCIS data exchange, and end-to-end product traceability is highly desirable.

• Knowledge of applicable GMP regulations and guidance, including FDA, EMA, and ICH requirements. Working knowledge of GCP and GDP is beneficial.

• Excellent attention to detail and documentation discipline, with the ability to recognize inconsistencies, assess risks, and follow issues through to resolution.

• A proactive, hands-on approach and the ability to balance routine operational responsibilities with evolving commercial launch priorities.

• Strong communication and collaboration skills, including the ability to work effectively with external partners, raise concerns constructively, and escalate issues when appropriate.

Benefits:

• Annual base salary: $175,000–$190,000 USD, depending on relevant experience, skills, qualifications, and internal equity.

• Additional compensation: Eligibility for an annual target bonus and equity compensation, as determined by the compensation committee.

• Healthcare coverage: Medical, dental, and vision insurance.

• Retirement and savings: Access to a 401(k) retirement plan and participation in the Employee Stock Purchase Plan.

• Insurance protection: Company-paid life insurance and short-term and long-term disability coverage.

• Time off: Paid time off and paid company holidays.

• Remote flexibility: Work remotely from anywhere in the continental United States.

• Travel: Up to 10% travel for conferences and company meetings.

• Meaningful impact: The opportunity to contribute to the commercial launch of an innovative smoking cessation treatment and support efforts to address nicotine dependence.