CMO Manager

Business Unit: Glenmark Europe Function: EU Quality Reporting to: Sr VP & Cluster Head – Quality EEM Location: Travel: Up to 50% international travel Role Overview Glenmark is seeking an experienced CMO QA Manager to provide strategic quality oversight of its global contract manufacturing network. The role is responsible for ensuring sustainable GMP compliance, driving quality excellence, and strengthening quality culture across external manufacturing partners. The successful candidate will provide leadership in quality risk management, sterility assurance, data integrity, technology transfer oversight, regulatory inspection readiness, supplier qualification and external manufacturing quality governance. The position requires a highly influential quality professional capable of building strong partnerships while maintaining independent quality oversight to protect patient safety, product quality and regulatory compliance. Key Responsibilities · Serve as primary quality oversight lead for assigned CMOs and external manufacturing partners. · Support annual audit plan and lead critical CMOs audits. · Support quality management system operation: Change Controls, Deviations and CAPAs. · Provide governance and escalation management for significant quality, compliance and supply risks. · Lead risk assessments and ensure alignment with ICH Q9 and global quality expectations. · Approve critical investigations and ensure scientific rigor and sustainable CAPA effectiveness. · Act as quality SME on new products launch, technology transfer, process validation, PPQ and lifecycle verification activities. · Support inspection readiness and regulatory authority interactions including FDA, EMA, MHRA and Swissmedic. · Drive continuous improvement initiatives across the external manufacturing network. · Monitor quality metrics, compliance trends and emerging risks. · Lead supplier and contractor qualification operation. · Chair or lead External Manufacturing Quality Review Boards and governance forums. · Support quality agreements negotiations and periodic business reviews. · Provide strategic recommendations regarding external manufacturing quality risks and mitigation strategies. Desired Experience · 7–10 years of pharmaceutical manufacturing and quality experience. · Minimum 5 years in external manufacturing, quality operations, quality systems, validation or CMO oversight roles. · Strongly preferred: Experience in leading manufacturing deviations and OOS/OOTs investigations. · Experience supporting global CMO networks across multiple regulatory jurisdictions. · Experience supporting regulatory inspections by FDA, EMA, MHRA, Swissmedic or equivalent authorities. · Experience leading or participating in GMP audits of CMOs, contract laboratories, suppliers and service providers. · Experience operating within a multi-country pharmaceutical quality organization. · Experience managing quality oversight for complex supply chains involving multiple manufacturing and testing partners. · Experience supporting product launches, technology transfers, remediation programs and major quality improvement projects. · Strongly preferred: Demonstrated experience within sterile manufacturing, aseptic processing, biological products or high-containment pharmaceutical operations, including EU GMP Annex 1 oversight. Knowledge & Skills Essential Skills · Strong understanding of EU GMP, FDA, ICH and PIC/S requirements. · Expertise in Quality Risk Management (ICH Q9). · Strong communication, influencing and stakeholder management skills. · Ability to evaluate complex technical quality issues and make risk-based decisions. · Adaptability and flexibility in a dynamic work environment · Proficiency with quality systems, quality metrics and digital quality platforms. · Fluency in English. Highly Preferred / Scarce Skills · Advanced knowledge of EU GMP Annex 1 and Contamination Control Strategies (CCS). · Sterility assurance and aseptic processing expertise. · Data Integrity expertise including ALCOA+ principles. · Experience leading microbiological, sterility and contamination investigations. · Technology transfer, process validation and PPQ oversight experience. · Knowledge of computerized systems validation and digital manufacturing quality systems. · Supplier quality management and critical supplier oversight experience. · Ability to identify systemic quality risks across multiple CMOs and drive strategic remediation. · Strong understanding of pharmaceutical supply chain risk management. · Experience using quality metrics and advanced trend analysis to identify systemic risks. · Knowledge of outsourced manufacturing regulatory expectations and data governance. · Ability to drive quality culture and quality maturity improvements within external organizations. Other Requirements · Willingness and ability to travel up to 50% internationally to support audits, inspections, governance meetings, technology transfers and business-critical quality activities. Preferred Certifications · ASQ CQA/CQE, IRCA Lead Auditor or equivalent · Six Sigma Green Belt or Black Belt · Quality Risk Management or Pharmaceutical Quality Systems certification