Senior Manager, Quality

Location: Clifton Park

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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 & Governance

* Provide strategic direction and leadership for the site Quality organization, including QC, QA, and Compliance

* Serve as the primary Quality authority at the site, accountable for Quality performance, risk management, and compliance posture

* Act as a core member of the site leadership team, shaping business strategy through a quality-first, risk-based approach

* Drive alignment with enterprise Quality strategies, global QMS frameworks, and network-wide initiatives

* Establish, 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 functions

Quality Systems, Regulatory Compliance & Controlled Environments

* Own and continuously enhance the site's QMS to ensure compliance with ISO 9001, GMP, and applicable global regulatory requirements

* Provide executive oversight of core QMS elements: document control, training, deviations, CAPA, change management, and risk management

* Lead Management Review with executive-level reporting on Quality system effectiveness, trends, and risks

* Serve as the primary site representative for regulatory inspections, customer audits, and external agency interactions

* Lead negotiation and approval of Quality Agreements and critical customer quality communications

* Ensure robust governance of controlled environments, including ISO 7 cleanroom and ISO 8 cleanroom operations

* Provide strategic oversight of Environmental Monitoring (EM) programs, including data trending, risk assessment, and escalation of excursions

* Partner with Manufacturing and Facilities to maintain validated state of control and contamination control strategies

* Ensure alignment with evolving regulatory expectations and industry best practices

Product Quality, Risk Management & Customer Experience

* Maintain ultimate accountability for product quality, disposition decisions, and batch release compliance

* Ensure robust, risk-based oversight of nonconformance, deviation investigations, and CAPA effectiveness

* Final authority on product disposition escalation

* Drive advanced root cause analysis and systemic issue resolution to prevent recurrence

* Oversee customer complaint processes, ensuring timely, compliant, and high-quality responses

* Analyze complaint and quality data trends to drive proactive improvements and risk mitigation

* Lead major quality events, recalls, or regulatory escalations

* Lead the internal audit program and ensure sustained inspection readiness across the site

* Ensure timely closure and effectiveness of audit observations and regulatory commitments

Operational Excellence & Enterprise Collaboration

* Partners with Manufacturing, Engineering, Supply Chain, and Product Management to embed quality into all operational processes

* Act as the senior Quality liaison between site operations and global/network Quality leadership

* Provide Quality leadership for new product introductions (NPI), validation strategies, and lifecycle management

* Drive operational excellence initiatives, including structured problem-solving and Lean/Six Sigma methodologies

* Lead initiatives to reduce Cost of Poor Quality (COPQ) and improve process capability and robustness

* Influence enterprise-level quality improvements through cross-site collaboration and best practice sharing

Education

* Bachelor's degree in Engineering, Life Sciences, or related field required

* Advanced degree (MS, MBA, or equivalent) strongly preferred

Experience

* 8-10 years of progressive Quality experience within regulated industries (biopharma, medical device, or life sciences)

* Significant…