Senior Manager, Quality Operations

Position Summary The Senior Manager, Quality Operations is responsible for providing strategic leadership and oversight of Quality Operations supporting Drug Substance (DS) and Drug Product (DP) manufacturing. This includes oversight of batch disposition, material release, deviations, investigations, CAPAs, change controls, Quality Risk Assessments, New Product Introduction (NPI), and GMP manufacturing support across routine and shift operations. The role ensures adequate quality resources, effective escalation processes, and continuous quality oversight are in place to support manufacturing activities while maintaining compliance with FDA, EU GMP, PIC/S GMP, ICH guidelines, and company quality standards.. Key Responsibilities · Provide quality oversight for DS and DP manufacturing operations, including routine and shift operations, to ensure GMP compliance and continuous manufacturing support. · Establish and maintain an effective QA support model to provide adequate quality oversight, escalation management, and decision-making for manufacturing activities across all operational shifts. · Lead review and approval of batch records, investigations, deviations, change controls, CAPAs, quality risk assessments, protocols, reports, and GMP documentation. · Make independent quality decisions on product quality, compliance, batch disposition, material release, and manufacturing events to support uninterrupted operations. · Provide timely quality support and guidance to Manufacturing during shift operations, including deviation assessment, event management, and resolution of quality-related issues. · Act as Quality Lead for NPI, technology transfer, process validation, and commercial readiness activities. · Ensure SOPs, Quality Risk Assessments, reports, specifications, and quality records comply with FDA, EU GMP, PIC/S GMP, ICH, and applicable regulatory requirements. · Support and participate in audit and inspection readiness programs and represent Quality Operations during client audits and regulatory inspections. · Collaborate effectively with Manufacturing, QC, MSAT, Engineering, Supply Chain, and global stakeholders. · Drive continuous improvement, quality culture, operational excellence, and compliance performance. · Develop and manage resource plans, shift coverage models, and on-call support strategies to ensure effective Quality Operations support for manufacturing activities. Leadership and Management Responsibilities · Lead, coach, develop, and retain a high-performing Quality Operations team. · Develop department resource plans to support business growth and project demands. · Manage staffing, succession planning, talent development, and organizational capability building. · Oversee project timelines, quality deliverables, department KPIs, and strategic initiatives. · Manage departmental budget planning and resource allocation to support operational objectives. · Provide leadership during quality escalations and support executive decision-making. · Lead, coach, develop, and retain a high-performing Quality Operation team. · Develop department resource plans to support business growth, site expansion, project execution, and operational demands. · Manage staffing, succession planning, talent development, and organizational capability building. · Oversee project timelines, quality deliverables, departmental KPIs, strategic initiatives, and compliance objectives. · Manage departmental budget planning and resource allocation to support operational and business objectives. · Collaborate effectively with Manufacturing, QC, Engineering, Validation, Supply Chain, Warehouse, Regulatory Affairs, and global stakeholders to ensure alignment on quality and compliance expectations. · Support site expansion, technology transfer, validation programs, digitalization initiatives, and business growth activities. · Provide leadership during quality escalations, compliance risks, and critical quality events, and support executive decision-making. · Foster a culture of quality, data integrity, accountability, continuous improvement, and operational excellence. Qualifications and Experience · Bachelor's Degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, Engineering, or related discipline. · Minimum 10 years of pharmaceutical, biotechnology, or CDMO GMP experience. · Minimum 5 years of leadership experience managing Quality Operations or related quality functions. · Strong experience in batch disposition, deviations, investigations, CAPA, change control, quality risk management, and GMP manufacturing support. · Experience supporting Regulatory Inspection and customer audits. Technical Competencies · Expert knowledge of FDA cGMP, EU GMP, PIC/S GMP, ICH Guidelines, Data Integrity, and Quality Risk Management principles. · Strong understanding of Drug Substance and Drug Product manufacturing processes. · Excellent quality decision-making, problem-solving, stakeholder management, and communication skills. · Ability to balance compliance requirements with business and operational objectives.