Quality Manager

JOB DESCRIPTION

Work Schedule

First Shift (Days)

Environmental Conditions

Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

How will you make an impact?

The Quality Manager receives assignments in the form of site and functional objectives and determines how to deploy people, time, and resources to meet schedules, quality standards, and business goals. This role provides leadership and guidance to the Quality Control and Quality Assurance organizations within established company policies, recommends improvements to policies and procedures, and ensures effective execution of QC laboratory operations and QA systems. The Quality Manager is accountable for short- to mid-term (1–2 year) performance, compliance, and continuous improvement results for the quality function, with primary emphasis on QC laboratory excellence while maintaining robust QA systems and compliance.

What will you do?

• Translate site and quality function objectives into actionable plans, priorities, and resource allocations to meet operational schedules and quality goals.
• Provide leadership and direction to the Quality Control team, managing through QC Supervisors as applicable, and ensuring alignment with site priorities.
• Ensure timely, compliant execution of QC testing, batch record review, and disposition of finished goods.
• Monitor quality performance metrics, identify trends, and take corrective actions to improve quality, efficiency, and reliability.
• Guide and support supervisors and individual contributors within established company policies, procedures, and quality systems.
• Recommend updates to QC and QA policies, procedures, and workflows and establish local procedures that impact the immediate organization.
• Manage the QA function to create a culture of quality awareness, teamwork, and compliance across the organization.
• Engage in daily oversight and guidance of nonconforming material investigations, complaint records, corrective and preventive actions, and change controls to drive timely and scientifically sound closure.
• Provide guidance and direction to stakeholders to ensure ISO 9001 compliance and Quality Management System adherence.
• Collaborate across functions and sites, leveraging quality and manufacturing expertise to troubleshoot problems, interpret data and determine next steps based on risk-based approach.
• Manage accuracy, completeness, and timeliness of Quality records.
• Lead external regulatory inspections and customer audits
• Oversee internal audits program.
• Develop quality talent through coaching, feedback, and performance management, with accountability for near-term capability needs, succession planning, and meeting personal career goals while achieving organization goals.
• Design, plan, and lead Practical Process Improvements (PPI) initiatives focusing on scientific practices, knowledge, best practice, standard work, or quality initiatives.

REQUIREMENTS

Education and Experience

• Advanced degree plus 6 years of experience, or Bachelor's degree plus 8 years of experience in regulated pharmaceutical/biotech/medical device industry
• Preferred Fields of Study: Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, Biotechnology, Engineering, Microbiology, or related scientific field

• 5+ years of people management experience leading QC laboratory teams
• Strong understanding of analytical testing methods and laboratory operations
• Knowledge of cGMP regulations, quality systems, and regulatory requirements preferred
• Demonstrated success implementing and improving quality systems and processes
• Experience with laboratory information management systems (LIMS) and data integrity requirements
• Experience leading conversations with customers and auditors and supporting regulatory inspections

Knowledge, Skills, Abilities

• Proven understanding of Quality Control Laboratory operating principles and Quality Assurance procedures, processes, and guidelines
• Leadership experience developing and mentoring staff with ability to affect performance and development of individuals across the Quality department
• Ability to drive functional, technical, and operational excellence
• Ability to think strategically with the ability to direct the resolution of technical problems using innovative approaches
• Project management and organizational skills
• Clear written and verbal communication skills with ability to analyze data, summarize results, present data, and address feedback
• Practical application experience in continuous improvement methodologies to improve processes, strengthen quality, and drive efficiency
• Highly skilled in Quality tools e.g. FMEA, Risk Analysis, Root Cause Analysis

Compensation and Benefits

The salary range estimated for this position based in New Jersey is $112,500.00–$155,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

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