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 key contact for regulatory agencies, customers, and other external stakeholders when appropriate.
- Prepare the organization for regulatory inspections and coordinate inspection activities.
- Lead regulatory inspection readiness and responses to regulatory findings.
- Evaluate regulatory risks associated with new products, processes, equipment, suppliers, and operational changes.
- Partner with Operations and other departments to ensure regulatory requirements are incorporated into day-to-day processes.
- Communicate changes in regulatory requirements to appropriate stakeholders.
- Ensure regulatory requirements are understood and consistently followed throughout the organization.
- Champion inspection readiness by providing Quality and Regulatory intelligence, implementation of continuous improvements and oversight of operations.
- Host and support the internal and external audits, including timely audit responses and completion of any resultant CAPAs and audit commitments.
- Serve as the site liaison for establishment registrations, NDC creations and labeling submissions.
- Lead the generation and maintenance of any Recalls and Field Actions required.
- Maintain accurate and current regulatory records.
- Report dotted line to Director, Regulatory
Quality Management System
- Lead the development, implementation, maintenance, and continuous improvement of the Quality Management System.
- Ensure Quality policies, SOPs, work instructions, specifications, forms, and other controlled documents are current and properly maintained.
- Oversee document control and quality records.
- Monitor QMS effectiveness through quality metrics, internal audits, management reviews, and trend analysis.
- Establish and maintain Quality KPIs and performance objectives.
- Identify opportunities to strengthen the QMS and improve operational effectiveness.
CAPA, Deviations & Investigations
- Oversee investigations involving product, process, equipment, documentation, and quality issues.
- Ensure appropriate root-cause analysis is performed.
- Manage the CAPA program from initiation through implementation, effectiveness verification, and closure.
- Review deviations, nonconformances, complaints, and other quality events for trends and systemic issues.
- Ensure corrective and preventive actions are appropriately documented and implemented.
- Assess the potential regulatory impact of significant quality events and ensure appropriate escalation.
Audits & Regulatory Inspections
- Lead preparation for FDA, customer, third-party, and other regulatory audits and inspections.
- Coordinate audit and inspection preparation, documentation, employee readiness, and responses.
- Lead and participate in internal and external audits.
- Ensure audit findings and observations are investigated and appropriately addressed.
- Develop and track corrective action plans resulting from audits and inspections.
- Maintain continuous inspection readiness across the organization.
Customer Complaints & Product Quality
- Oversee customer complaint investigations and quality-related customer concerns.
- Ensure complaints are appropriately documented, investigated, and resolved.
- Evaluate complaints for potential regulatory reporting requirements.
- Monitor complaint trends and identify recurring issues.
- Coordinate corrective actions with Quality, Regulatory Compliance, Operations, and other departments.
- Ensure appropriate follow-up and documentation are completed.
Change Control
- Oversee Quality and Regulatory Compliance involvement in change control activities.
- Evaluate proposed changes for quality and regulatory impact.
- Ensure appropriate documentation, approvals, validation, and implementation activities are completed.
- Determine when regulatory notification, submission, or approval may be required.
Supplier Quality
- Support supplier qualification and ongoing supplier performance monitoring.
- Evaluate supplier-related quality and regulatory risks.
- Participate in supplier audits and corrective action activities.
- Partner with Supply Chain and Purchasing to address supplier quality and compliance issues.
Training & Development
- Ensure Quality and operational employees receive appropriate Quality and Regulatory Compliance training.
- Develop and maintain Quality and regulatory training programs.
- Ensure employees understand applicable SOPs, regulatory requirements, and compliance expectations.
- Maintain training records and monitor completion.
- Identify skill gaps and implement appropriate training and development programs.
Continuous Improvement
- Identify opportunities to improve quality, compliance, efficiency, and operational consistency.
- Use Quality and regulatory data to identify trends and areas for improvement.
- Partner with Operations to reduce defects, errors, rework, waste, and process variation.
- Support Lean, Six Sigma, root-cause analysis, and other continuous improvement initiatives.
- Promote a proactive approach to identifying and preventing quality and compliance issues.
Reporting & Metrics
- Establish and monitor Quality and Regulatory KPIs.
- Provide regular Quality and regulatory performance reports to senior leadership.
- Analyze trends and communicate risks, opportunities, and recommended actions.
- Track audit findings, CAPAs, complaints, deviations, and other quality metrics.
- Develop and implement action plans when performance targets are not achieved.
Department: Quality & Regulatory Compliance
Reports To: Sr. Director of Quality and dotted line to Director, Regulatory
Days/Hours: Monday-Friday, 8:30-5:00pm (Some additional hours needed in the evenings and/or weekends)
Qualifications
- Bachelor's degree in Quality, Regulatory Compliance, Life Sciences, Engineering, Pharmacy, Chemistry, Biology, or a related field.
- Minimum of 7 years of progressive experience in Quality Assurance, Quality Management, Regulatory Compliance, or a combination of these disciplines.
- Minimum of 3 years of direct Regulatory Compliance or regulatory compliance experience in a regulated industry.
- Demonstrated experience working directly with applicable regulatory requirements and regulatory agencies, preferably the FDA.
- Demonstrated experience preparing for and supporting regulatory inspections and audits.
- Experience interpreting regulatory requirements and translating them into operational policies, procedures, and processes.
- Demonstrated experience managing Quality personnel, preferably in a multi-shift manufacturing or regulated environment.
- Experience managing Quality employees across multiple shifts, including 1st, 2nd, and 3rd Shift operations.
- Strong experience with Quality Management Systems.
- Demonstrated experience with CAPA, deviations, nonconformances, investigations, root-cause analysis, and change control.
- Experience managing or responding to customer complaints and evaluating potential regulatory implications.
- Strong knowledge of applicable FDA regulations and relevant industry standards.
- Proven leadership, coaching, and employee development experience.
- Excellent written and verbal communication skills.
- Strong analytical, organizational, and problem-solving skills.
- Ability to work effectively with employees and leaders at all levels of the organization.
Preferred Qualifications
- ASQ certification such as Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA).
- Lean Six Sigma certification.
- Experience working in a pharmaceutical, medical device, healthcare, biotechnology, or other FDA-regulated environment.
- Experience with GMP, GDP, ISO 9001, ISO 13485, or other applicable quality standards.
- Experience with electronic Quality Management Systems.
- Experience with regulatory submissions, product registrations, or regulatory notifications.
- Direct experience interacting with FDA or other regulatory agencies.
Physical & Work Environment
- Ability to work in both an office and regulated manufacturing/production environment.
- Ability to regularly visit production areas across 1st, 2nd, and 3rd Shifts as necessary, with additional support for our Weekend Shift when needed.
- Ability to stand, walk, and move throughout the facility as required.
- Must comply with all company safety, Quality, regulatory, and PPE requirements.
- Occasional flexibility in work schedule may be required to support audits, inspections, investigations, and critical Quality or regulatory matters.
