Manager, Quality Operations

Responsibilities:

• Serve as a Quality Operations lead for complex CMC, commercial, and clinical supply programs by providing strategic quality direction, risk-based decision-making, and timely issue escalation
• Provide quality oversight of contract manufacturing organizations, contract testing laboratories, suppliers, and other external partners to ensure compliance with approved procedures, regulatory expectations, and quality agreements
• Review and approve GMP documentation, including batch records, analytical data, investigations, deviations, CAPAs, change controls, validation documentation, and product disposition records
• Lead or oversee quality investigations related to manufacturing, testing, packaging, labeling, storage, distribution, and product release activities, ensuring timely root cause analysis and effective corrective and preventive actions
• Review and approve validation protocols and reports, including process validation, analytical method validation, cleaning validation, packaging validation, and shipping lane qualification, as applicable
• Lead or support audits of suppliers, CLOs, CMOs, and service providers, including audit planning, execution, reporting, response evaluation, and follow-up of corrective actions
• Develop, monitor, and communicate Quality metrics and trend reports to identify compliance risks, recurring issues, and opportunities for continuous improvement
• Partner cross-functionally with CMC, Regulatory Affairs, Technical Operations, Supply Chain, Clinical Operations, and Commercial teams to support submissions, inspections, product launches, and lifecycle management activities
• Mentor and guide Quality Operations staff and cross-functional team members, as applicable, to strengthen technical capability, inspection readiness, and operational excellence

Preferred Skills, Qualifications and Technical Proficiencies:

• An understanding of pharmaceutical manufacturing, analytical testing, validation, quality systems, and global cGMP expectations for commercial and clinical products
• Demonstrated ability to apply sound quality judgment, assess compliance risk, and make recommendations that support regulatory compliance, patient safety, product quality, and business continuity
• Experience with batch record review, product disposition, deviation management, CAPA, change control, validation, supplier quality, and quality agreement oversight
• Proven ability to lead cross-functional teams, influence stakeholders, and manage complex quality issues with internal departments and external partners
• Experience leading or supporting regulatory inspections and internal or external audits, including inspection readiness, response preparation, and remediation activities
• Ability to author, review, approve, and improve SOPs, quality agreements, risk assessments, technical reports, and other controlled documentation
• Strong analytical, problem-solving, and communication skills, including the ability to present quality risks, metrics, and recommendations clearly to senior management
• Ability to manage multiple priorities independently in a fast-paced, matrixed environment while maintaining compliance, accountability, and attention to detail
• Experience developing, analyzing, and presenting Quality metrics and trend reports
• Proficiency with Microsoft Word, Excel, PowerPoint, Visio, Smartsheet, and electronic quality management systems
• Ability to travel up to 20%

Preferred Education and Experience:

• Bachelor’s or Master’s degree in science, engineering, pharmacy, or a related field; advanced degree preferred
• 6+ years of progressive Quality Assurance experience in the pharmaceutical, biotechnology, or other regulated life sciences industry
• Strong working knowledge of 21 CFR Parts 210/211, 21 CFR Part 11, EU GMP, ICH guidelines, and other applicable global regulations governing the development, manufacture, testing, release, distribution, and control of pharmaceutical products