Senior Quality and Regulatory Manager

Safecor Health•Woburn, MA

4d•$110 - $155•Onsite

About The Position

The Senior Quality and Regulatory Manager provides strategic and operational leadership for the organization’s Quality Assurance and Regulatory Compliance functions. The role ensures that products, processes, systems, and operations meet company quality standards, customer expectations, and applicable regulatory requirements. The manager leads a Quality team of seven employees across first, second, and third shifts, ensuring consistent quality support and oversight throughout operating hours. Periodic weekend support may be needed for line clearances and weekend-shift operations. The role oversees the Quality Management System (QMS), regulatory compliance, audits and inspections, CAPA, investigations, document control, customer complaints, supplier quality, training, and continuous improvement. It works with Operations, Manufacturing, Supply Chain, Engineering, senior leadership, and other departments to interpret regulatory requirements, manage risks, maintain inspection readiness, and translate requirements into practical operational procedures. The position reports to the Senior Director of Quality and has a dotted-line reporting relationship to the Director, Regulatory. The position is based in Woburn, Massachusetts. The stated schedule is Monday through Friday, 8:30 a.m. to 5:00 p.m., with some additional evening and weekend hours as needed. Work takes place in both an office and regulated manufacturing or production environments, with visits to production areas across shifts as necessary.

Requirements

Bachelor’s degree in Quality, Regulatory Compliance, Life Sciences, Engineering, Pharmacy, Chemistry, Biology, or a related field.
At least 7 years of progressive experience in Quality Assurance, Quality Management, Regulatory Compliance, or a combination of these disciplines.
At least 3 years of direct 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.
Experience managing Quality personnel, preferably in a multi-shift manufacturing or regulated environment, including employees across first, second, and third shifts.
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 organizational levels.
Ability to work in both an office and regulated manufacturing or production environment and to visit production areas across shifts as necessary.
Ability to stand, walk, and move throughout the facility as required.
Must comply with company safety, Quality, regulatory, and PPE requirements.
Occasional schedule flexibility may be required to support audits, inspections, investigations, and critical Quality or regulatory matters.

Nice To Haves

ASQ certification such as Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA).
Lean Six Sigma certification.
Experience 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 the FDA or other regulatory agencies.

Responsibilities

Provide strategic and operational leadership for Quality Assurance and Regulatory Compliance activities and develop strategies aligned with organizational objectives.
Build a culture of quality, regulatory compliance, accountability, and continuous improvement; advise senior leadership on quality, compliance, and regulatory risks.
Monitor emerging regulatory requirements and ensure they are incorporated into company policies, procedures, and processes.
Manage, coach, mentor, and performance-manage seven Quality employees across first, second, and third shifts; coordinate staffing, scheduling, coverage, workload, training, cross-training, and succession planning.
Establish consistent quality practices and effective communication and handoffs across shifts, including communication of critical quality, compliance, production, and regulatory issues.
Develop, implement, and maintain regulatory compliance programs and documentation; support regulatory submissions, registrations, notifications, and other regulatory activities.
Serve as an appropriate contact for regulatory agencies, customers, and external stakeholders; prepare for and coordinate regulatory inspections and responses to findings.
Host and support internal and external audits, ensure timely responses, and complete resulting CAPAs and audit commitments.
Serve as site liaison for establishment registrations, NDC creations, and labeling submissions; lead the generation and maintenance of required recalls and field actions.
Maintain accurate and current regulatory records and champion inspection readiness through regulatory intelligence, continuous improvement, and oversight of operations.
Lead the development, implementation, maintenance, and improvement of the QMS; oversee controlled documents and quality records and monitor QMS effectiveness through metrics, audits, management reviews, and trend analysis.
Establish Quality KPIs and performance objectives, analyze trends, report performance and risks to senior leadership, and develop action plans when targets are not met.
Oversee investigations into product, process, equipment, documentation, and quality issues; ensure root-cause analysis and appropriate escalation of regulatory impacts.
Manage CAPAs from initiation through implementation, effectiveness verification, and closure; review deviations, nonconformances, complaints, and other events for trends and systemic issues.
Lead preparation for and participation in FDA, customer, third-party, internal, and other regulatory audits and inspections; coordinate readiness, documentation, employee preparation, and responses.
Oversee customer complaint investigations and resolution, evaluate potential regulatory reporting requirements, monitor trends, and coordinate corrective actions.
Oversee Quality and Regulatory Compliance involvement in change control; evaluate impacts and ensure documentation, approvals, validation, implementation, and any required regulatory notifications or submissions are completed.
Support supplier qualification and performance monitoring; evaluate supplier risks, participate in supplier audits and corrective actions, and partner with Supply Chain and Purchasing on supplier issues.
Develop and maintain Quality and regulatory training programs, ensure employees receive appropriate training, maintain training records, monitor completion, and address skill gaps.
Identify and implement improvements to quality, compliance, efficiency, and operational consistency; use data to reduce defects, errors, rework, waste, and process variation, and support Lean, Six Sigma, and root-cause analysis initiatives.
Track audit findings, CAPAs, complaints, deviations, and other quality metrics; communicate trends, risks, opportunities, and recommended actions.