Quality Manager - Bridgewater & Fair Lawn, NJ

Thermo Fisher Scientific

Life Science

Fair Lawn, NJ - USA

Manager / Team Leader

Experteer Overview

As Quality Manager, you lead QC and QA functions to ensure compliant, timely quality operations that meet site and functional goals. You translate objectives into actionable plans, guiding QC teams and sustaining robust QA systems. You drive continuous improvement in testing, documentation, and change control, while preparing for regulatory inspections and audits. You will collaborate across sites to troubleshoot issues, interpret data, and shape quality programs that support patient safety and product integrity. This role offers a chance to impact global quality standards within a mission-driven, science-focused environment.

Compensation / Benefits

Health and dental plans
Vision plan
PTO (at least 120 hours) and paid holidays
Parental leave and caregiver leave
401(k) retirement savings plan
Employee stock purchase plan (ESPP)

Responsibilities

Translate objectives into plans, priorities, and resource allocations to meet schedules and quality goals
Provide leadership to the Quality Control team and align with site priorities
Ensure timely, compliant QC testing, batch record review, and disposition of finished goods
Monitor quality metrics, identify trends, and implement corrective actions
Guide supervisors and contributors within policy and quality systems
Update QC/QA policies and local procedures affecting the organization
Manage QA to foster a culture of quality, teamwork, and compliance
Oversee nonconforming material investigations, CAPA, and change controls for timely closure
Ensure ISO 9001 compliance and QMS adherence
Collaborate across functions/sites to troubleshoot problems and apply risk-based decisions
Maintain accuracy and timeliness of Quality records
Lead external regulatory inspections and customer audits
Oversee internal audits program
Develop quality talent through coaching, performance management, and succession planning
Design and lead Practical Process Improvements (PPI) focusing on quality practices and standard work

Key requirements

Advanced degree plus 6 years of experience, or Bachelor's degree plus 8 years in regulated pharma/biotech/medical device industry
5+ years of people management leading QC labs
Strong understanding of analytical testing methods and lab operations
Knowledge of cGMP regulations, quality systems, and regulatory requirements (preferred)
Proven track record implementing and improving quality systems and processes
Experience with LIMS and data integrity requirements
Experience leading conversations with customers and auditors and supporting regulatory inspections
Quality Control Laboratory operating principles and QA procedures knowledge
Leadership in mentoring staff and driving performance and development
Ability to drive functional, technical, and operational excellence
Strategic thinking with ability to resolve technical problems innovatively
Project management and strong organizational skills
Effective written and verbal communication, data analysis and presentation skills
Practical use of continuous improvement methodologies to boost quality and efficiency
Proficiency with quality tools such as FMEA, risk analysis, root cause analysis

Leadership Strategic thinking Effective communication LIMS Quality systems (GMP/QMS)cGMP knowledge

Description

As Quality Manager, you lead QC and QA functions to ensure compliant, timely quality operations that meet site and functional goals. You tra…

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