Senior Manager, Quality

RepliGen Corporation•Clifton Park, NY

7d•$130,000 - $150,000•Onsite

About The Position

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.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or related field required
12+ 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 environment
Deep expertise in QMS, regulatory compliance, and quality risk management (ISO 9001, GMP, cleanroom operations)
Demonstrated success leading through regulatory inspections, audits, and complex customer interactions
Proven ability to drive large-scale quality improvements and organizational transformation
Regularly required to bend, reach, stand, walk, and sit
Vision must be correctable to detect cosmetic and workmanship defects

Nice To Haves

Advanced degree (MS, MBA, or equivalent) strongly preferred
Experience with gamma irradiation and X-ray sterilization, including supplier oversight and dose validation
Experience with enterprise systems such as Salesforce and SAP
Familiarity with BPOG guidance and customer communication alignment

Responsibilities

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
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
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
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