Senior Manager, Quality Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Conduct comprehensive technical evaluations of completed batch records, Certificates of Analysis, Certificates of Compliance, laboratory data, stability outcomes, and related release documentation.

• Detect discrepancies, absent information, and possible compliance issues.

• Collaborate with CDMOs to ensure prompt batch disposition and release.

• Manage the initial intake, triage, and examination of deviations, investigations, CAPAs, and OOS events from external manufacturing partners.

• Review investigation documentation and evaluate product quality and compliance risks.

• Track resolution timelines while assisting in root cause analysis and corrective actions.

• Engage in product complaint investigations.

• Aid in establishing commercial complaint-management processes, responsibilities, documentation, and workflows.

• Utilize risk-based judgment to assess impacts on product quality and patient safety.

• Facilitate the transition from clinical-stage quality practices to commercial quality operations.

• Establish processes and controls for commercial manufacturing, product release, distribution, and post-approval requirements.

• Assist with DSCSA serialization and EPCIS data exchange with CDMOs and 3PL providers.

• Confirm the accuracy and completeness of traceability data from manufacturer to distributor.

• Act as the primary Quality Operations contact for CDMOs and the 3PL.

• Follow up on documentation, quality events, release criteria, and distribution matters.

• Observe operational quality trends while supporting vendor performance assessments and qualification processes.

• Participate in Person-in-Plant oversight as necessary.

• Maintain thorough, accurate, and inspection-ready documentation.

• Support Quality Operations metrics and initiatives for continuous improvement.

• Assist in the preparation of the Annual Product Review.

⛳️ Requirements

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

• A minimum of 7 years of GMP Quality experience within the biotechnology or pharmaceutical industry.

• Ideally, experience encompassing late-stage clinical development and commercial readiness.

• Practical experience in reviewing batch records, release documentation, analytical results, and stability data.

• Background in evaluating deviations, investigations, CAPAs, or other quality events and their potential effects on product quality, regulatory compliance, and patient safety.

• Experience collaborating with CDMOs or other external manufacturing partners in an outsourced pharmaceutical or biologics setting.

• Understanding of quality and distribution requirements for the transition from clinical supply to commercial product.

• Preferred knowledge of DSCSA serialization, EPCIS data exchange, and end-to-end product traceability.

• Familiarity with relevant GMP regulations and guidelines, including FDA, EMA, and ICH requirements.

• Working knowledge of GCP and GDP is advantageous.

• Exceptional attention to detail and documentation rigor.

• Ability to identify inconsistencies, assess risks, and pursue issues through to resolution.

• Proactive, hands-on demeanor with the capability to function effectively in a lean organization.

• Strong communication and collaboration abilities.

• Capacity to work productively with external partners, constructively raise concerns, and escalate issues when necessary.

• Candidates may reside anywhere within the continental United States.

• Travel of up to 10% may be required.

🏝️ Benefits

• Annual target bonus.

• Equity compensation.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) retirement plan.

• Employee Stock Purchase Plan.

• Company-paid life insurance.

• Short- and long-term disability coverage.

• Paid time off.

• Paid company holidays.

• Remote work arrangement.

• Travel opportunities for conferences and company meetings.