Quality & Regulatory Leader - Multi-Shift Operations

Safecor Health; Woburn (MA); On-site; USD 120,000 - 170,000; Full time

Job summary

Safecor Health seeks a Senior Quality Manager to lead Quality Assurance and Regulatory Compliance across its operations. The role oversees the QMS, CAPA, audits, and regulatory readiness while guiding a seven-person team across three shifts in a fast-paced manufacturing environment.

The ideal candidate has extensive QA/regulatory experience, strong leadership, and the ability to translate regulatory expectations into practical procedures and continuous improvements.

Qualifications

• Bachelor's degree in Quality or related field.
• 7+ years in QA or regulatory compliance.
• Experience with FDA regulations and inspections.
• Experience managing multi-shift quality teams.
• Strong leadership and communication skills.

Responsibilities

• Provide strategic and operational leadership for QA and regulatory compliance.
• Lead 7-person quality team across three shifts.
• Maintain QMS and oversee CAPA, audits, and inspections.
• Prepare for FDA inspections and regulatory submissions.
• Develop quality metrics and drive continuous improvement.

Skills

Quality Leadership

Regulatory Compliance

Quality Management Systems

CAPA & Investigations

Cross-functional Leadership

FDA Regulations

Education

Bachelor's degree in Quality, Regulatory Compliance, Life Sciences, Engineering, Pharmacy, Chemistry, Biology

Tools

eQMS

Job description

Safecor Health seeks a Senior Quality Manager to lead Quality Assurance and Regulatory Compliance across its operations. The role oversees the QMS, CAPA, audits, and regulatory readiness while guiding a seven-person team across three shifts in a fast-paced manufacturing environment.

The ideal candidate has extensive QA/regulatory experience, strong leadership, and the ability to translate regulatory expectations into practical procedures and continuous improvements.