The Impact You Will Make

The Senior Quality Operations Manager is responsible for establishing and leading the Quality Operations function, including the implementation of a sustainable Quality on-the-Shop-Floor program that ensures product quality, regulatory compliance, and operational excellence. The role provides strategic and operational leadership for Quality Operations, including workforce planning, performance management, resource allocation, and continuous improvement initiatives aligned with site and corporate quality objectives.

The Senior Manager, Quality Operations leads a team of direct reports and exercises independent judgments in matters affecting manufacturing quality, compliance, and operational performance. The role serves as a key partner to Operations, Engineering, Quality Control, and other functions by providing direction on quality risks, manufacturing issues, investigations, and compliance-related decisions to support a compliant and efficient manufacturing environment.

ESSENTIAL DUTIES AND ROLE RESPONSIBILITIES

Department Leadership & People Management

• Defines and implements a Quality Operations Program
• Leads and manages the Quality Operations department, including a team of direct reports.
• Sets department goals, establishes annual performance expectations, and ensures alignment with site strategy and regulatory commitments.
• Conducts hiring interviews, recommends selection decisions, and provides direct input on hiring and firing decisions that carry particular weight in final outcomes.
• Oversees coaching, disciplinary actions, performance reviews, training plans, and developmental objectives for all direct reports.
• Ensures Quality Operations staff maintain qualifications, follow compliance expectations, and consistently execute responsibilities with independence and accuracy.

Quality Decision Authority - Real-Time Manufacturing Oversight

• Serves as the primary quality decision-maker for manufacturing issues and in-process control challenges.
• Provides real-time direction to Quality on the-Floor on quality pathways and risk mitigations.
• Resolves escalated issues independently, determining containment, documentation, and corrective actions required to maintain compliance.

Investigation, Deviations, CAPA & Compliance Governance

• Oversees the quality of all minor deviations, investigations, and CAPA records generated during the manufacture of product to ensure regulatory-compliant root-cause analysis, timely closures, and adequate effectiveness checks.
• Identifies systemic issues and drive cross-functional corrective actions that influence Production, Engineering, Validation, QC, and Supply Chain.
• Escalates significant compliance risks to senior leadership with recommended paths forward.

Audit, Inspection, and External Interface Leadership

• Serves as a technical lead and departmental representative during regulatory inspections and customer audits.
• Maintains a constant state of audit readiness through periodic internal audits, metric reviews, and process confirmation activities.

Operational Excellence & Quality Systems Improvement

• Leads quality improvement initiatives using Lean, Six Sigma, and structured problem-solving methodologies, targeting enhancement of manufacturing robustness.
• Champions site compliance programs and support training on strategy improvements as they related to the manufacturing process.
• Develops, implements, and monitors Quality Operations KPIs to improve system performance, prevent recurrence of issues, and support strategic decision-making.

Resource Planning, Budgeting & Cross-Functional Leadership

• Owns department resource plans and coordinates staffing decisions through S&OP demand planning.
• Manages and delivers the Quality Operations budget, including personnel, tools, training, and equipment needs.
• Participates in strategic meetings, steering committees, and cross-functional leadership forums to influence manufacturing quality and business priorities.

REQUIRED QUALIFICATIONS

Education

• Bachelor's degree or higher in Engineering, Life Sciences, or a related technical discipline.

Experience

• Minimum 10 years in a pharmaceutical, medical device, or similarly regulated manufacturing environment.
• Minimum 7 years managing technical staff (quality, engineering, or manufacturing), including demonstrable experience leading teams of 3+ FTE.
• Proven involvement in hiring, disciplinary actions, and termination recommendations.

Technical & Leadership Skills

• Deep expertise in GMP, manufacturing processes, quality systems, deviation/CAPA, and equipment/process troubleshooting.
• Ability to make independent technical decisions that impact compliance, product quality, and customer commitments.
• Strong communication skills with the ability to represent site quality operations to senior management, regulatory inspectors, and external customers.
• Proficiency in Lean/Six Sigma methodologies and data-driven decision-making.

#LI-Onsite

The expected compensation range for this position represents a good faith estimate. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate's relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, & Vision, Health Savings Accounts, Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences, and 401k Benefits, etc.).

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