Senior Manager, Quality

Make a global impact—join Repligen.We’re united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs that improve human health worldwide. No matter your role or background, at Repligen, you will play a key part in shaping some of the most innovative and life-changing therapies in the world. We foster a culture of purpose, collaboration, and shared success—where every voice matters and every contribution drives progress. Join us!The Senior Quality Manager is the senior-most Quality leader for the Clifton Park site, accountable for end-to-end Quality strategy, execution, and performance. This role ensures sustained product quality, regulatory compliance, and advancement of the Quality Management System (QMS), while driving a proactive quality culture and continuous improvement mindset across the site.Reporting to the Senior Director of Quality for the Fluid Management Network, this role provides strategic leadership over Quality Control (QC), Quality Assurance (QA), and Compliance functions, and serves as a key advisor to site and global leadership.This role is expected to model our Leadership Behaviors—Integrity & Compliance, Customer Focus, Collaboration, Courage, Team Empowerment, and Accountability & Results—in all aspects of work.Strategic Quality Leadership & GovernanceProvide strategic direction and leadership for the site Quality organization, including QC, QA, and ComplianceServe as the primary Quality authority at the site, accountable for Quality performance, risk management, and compliance postureAct as a core member of the site leadership team, shaping business strategy through a quality-first, risk-based approachDrive alignment with enterprise Quality strategies, global QMS frameworks, and network-wide initiativesEstablish, monitor, and continuously improve site-level Quality KPIs (e.g., DPPM, CAPA effectiveness, audit outcomes, COPQ)Champion a culture of quality, accountability, and continuous improvement across all functionsQuality Systems, Regulatory Compliance & Controlled EnvironmentsOwn and continuously enhance the site’s QMS to ensure compliance with ISO 9001 , GMP, and applicable global regulatory requirementsProvide executive oversight of core QMS elements: document control, training, deviations, CAPA, change management, and risk managementLead Management Review with executive-level reporting on Quality system effectiveness, trends, and risksServe as the primary site representative for regulatory inspections, customer audits, and external agency interactionsLead negotiation and approval of Quality Agreements and critical customer quality communicationsEnsure robust governance of controlled environments, including ISO 7 cleanroom and ISO 8 cleanroom operationsProvide strategic oversight of Environmental Monitoring (EM) programs, including data trending, risk assessment, and escalation of excursionsPartner with Manufacturing and Facilities to maintain validated state of control and contamination control strategiesEnsure alignment with evolving regulatory expectations and industry best practicesProduct Quality, Risk Management & Customer ExperienceMaintain ultimate accountability for product quality, disposition decisions, and batch release complianceEnsure robust, risk-based oversight of nonconformance, deviation investigations, and CAPA effectivenessFinal authority on product disposition escalationDrive advanced root cause analysis and systemic issue resolution to prevent recurrenceOversee customer complaint processes, ensuring timely, compliant, and high-quality responsesAnalyze complaint and quality data trends to drive proactive improvements and risk mitigationLead major quality events, recalls, or regulatory escalationsLead the internal audit program and ensure sustained inspection readiness across the siteEnsure timely closure and effectiveness of audit observations and regulatory commitmentsOperational Excellence & Enterprise CollaborationPartners with Manufacturing, Engineering, Supply Chain, and Product Management to embed quality into all operational processesAct as the senior Quality liaison between site operations and global/network Quality leadershipProvide Quality leadership for new product introductions (NPI), validation strategies, and lifecycle managementDrive operational excellence initiatives, including structured problem-solving and Lean/Six Sigma methodologiesLead initiatives to reduce Cost of Poor Quality (COPQ) and improve process capability and robustnessInfluence enterprise-level quality improvements through cross-site collaboration and best practice sharingEducationBachelor’s degree in Engineering, Life Sciences, or related field requiredAdvanced degree (MS, MBA, or equivalent) strongly preferredExperience8-10 years of progressive Quality experience within regulated industries (biopharma, medical device, or life sciences)Significant leadership experience managing multi-functional Quality organizations in a manufacturing environmentDeep expertise in QMS, regulatory compliance, and quality risk management (ISO 9001, GMP, cleanroom operations)Demonstrated success leading through regulatory inspections, audits, and complex customer interactionsProven ability to drive large-scale quality improvements and organizational transformationPreferredExperience with gamma irradiation and X-ray sterilization, including supplier oversight and dose validationExperience with enterprise systems such as Salesforce and SAPFamiliarity with BPOG guidance and customer communication alignmentKey CompetenciesStrategic leadership and executive presenceEnterprise thinking and decision-making under ambiguityAdvanced problem-solving and risk managementCross-functional influence at senior levelsData-driven performance managementOrganizational development and talent leadershipPhysical RequirementsRegularly required to bend, reach, stand, walk, and sitVision must be correctable to detect cosmetic and workmanship defectsOur mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated base salary range for this role, based in the United States of America is $130,000 - 150,000. Compensation decisions are dependent on several factors including, but not limited to an individual's qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer. #J-18808-Ljbffr RepliGen Corporation