Senior Quality and Regulatory Manager

The Senior Quality Manager is responsible for providing strategic and operational leadership for the organization's Quality and Regulatory Compliance functions. This position ensures that products, processes, systems, and operations consistently meet company quality standards, customer expectations, and applicable regulatory requirements.

The Senior Quality Manager will directly manage a Quality team of seven employees across three shifts—1st, 2nd, and 3rd Shift—ensuring consistent Quality support, compliance, and oversight across all operating hours. Some additional support may be needed periodically, from the manager, on the weekends during our Weekend Shift operations to support line clearances.

This position will oversee the Quality Management System (QMS), Regulatory Compliance, regulatory compliance, audits, CAPA, investigations, document control, customer complaints, supplier quality, training, and continuous improvement initiatives.

The ideal candidate will have significant experience in both Quality Management and Regulatory Compliance, with a demonstrated ability to interpret regulatory requirements, maintain compliance, prepare for regulatory inspections, and translate regulatory expectations into practical operational procedures.

The ideal candidate is a collaborative leader who builds strong teams across diverse backgrounds and disciplines, keeping quality, regulatory compliance, and operational performance aligned.

Essential Responsibilities Quality & Regulatory Leadership Provide strategic and operational leadership for Quality Assurance and Regulatory Compliance activities.

Establish and maintain a culture of quality, regulatory compliance, accountability, and continuous improvement.

Serve as a senior Quality and Regulatory Compliance resource to Operations, Manufacturing, Supply Chain, Engineering, and other departments.

Advise senior leadership regarding quality, compliance, and regulatory risks.

Develop and maintain quality and regulatory strategies aligned with organizational objectives.

Identify emerging regulatory requirements and evaluate their impact on company operations.

Ensure regulatory requirements are effectively incorporated into company policies, procedures, and processes.

Quality Team Management Directly manage a team of seven Quality employees across 1st, 2nd, and 3rd Shifts.

Provide leadership, coaching, mentoring, and performance management for Quality team members.

Establish clear performance expectations, objectives, and accountability standards.

Ensure appropriate Quality coverage and support across all three shifts.

Coordinate staffing, scheduling, shift coverage, and workload distribution.

Ensure consistent application of Quality policies, procedures, SOPs, and regulatory requirements across all shifts.

Establish effective communication and handoff processes between shifts.

Ensure critical quality, compliance, production, and regulatory issues are communicated appropriately between shifts and management.

Identify training and development opportunities for Quality personnel.

Develop cross-training and succession plans to maintain continuity of Quality operations.

Foster a culture of teamwork, accountability, regulatory compliance, and continuous improvement.

Regulatory Compliance Maintain strong working knowledge of applicable FDA regulations, federal and state requirements, and industry standards.

Monitor changes to applicable regulations, guidance documents, and industry standards and assess their impact on company operations.

Develop, implement, and maintain regulatory compliance programs.

Prepare and maintain regulatory documentation and records.

Support regulatory submissions, registrations, notifications, and other regulatory activities as applicable.

Serve as a…