Senior Manager, Quality Excellence & Compliance

HireLifeScience; Marlborough (MA); On-site; USD 135,000 - 190,000; Full time

Benefits offered by this job

Paid time off

Health/Dental/Vision

Retirement benefits

Flexible spending accounts

Job summary

HireLifeScience in Marlborough, MA is seeking a Senior Manager of Quality to strengthen quality systems, drive continuous improvement, and foster a culture of quality across the site. You will partner with global teams, lead key quality programs, and use metrics to drive data-based decisions.

The role requires 10+ years in regulated environments, 4+ years of leadership, and strong expertise in QMS, CAPA, validation, and GDP.

Qualifications

• Bachelor's degree in a scientific discipline is required.
• 10+ years in ISO 9001/13485 and cGMP environments.
• 4+ years of people leadership experience.
• Experience with audits, CAPA, validation, and document control.

Responsibilities

• Maintain ISO 9001, CAPA, nonconforming material management, validation, and document control.
• Lead and develop direct reports to build a high-performing team.
• Drive quality initiatives to improve performance and compliance.
• Support enterprise-wide quality processes with global stakeholders.
• Develop and communicate quality metrics and KPIs.
• Lead internal and external audit programs and CAPA actions.
• Oversee risk-based investigations and deviation management.
• Identify continuous improvement opportunities and digitalisation efforts.
• Collaborate on product release activities and operational priorities.
• Balance strategic priorities with day-to-day execution.

Skills

QMS Auditing

Leadership

Cross-functional collab

CAPA Processes

Root Cause Analysis

GDP Knowledge

Lean Methods

Risk Management

Education

Bachelor's degree in Chemistry/ Biology/ Engineering

Job description

HireLifeScience in Marlborough, MA is seeking a Senior Manager of Quality to strengthen quality systems, drive continuous improvement, and foster a culture of quality across the site. You will partner with global teams, lead key quality programs, and use metrics to drive data-based decisions.

The role requires 10+ years in regulated environments, 4+ years of leadership, and strong expertise in QMS, CAPA, validation, and GDP.