Sr. Manager (Site Quality Head) at Thermo Fisher Scientific

Mt Prospect, Illinois, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Biotech, Clinical TrialsIndustries

Requirements

Bachelor’s degree in a scientific or technical field (advanced degree preferred)
At least 7-8 years of dynamic Quality leadership experience in the pharmaceutical or medical device industry, including contract manufacturing, packaging, or distribution
Extensive understanding of cGMP, FDA, EMA, and other global regulatory requirements, with a track record of effectively coordinating inspections and ensuring compliance
3-5 years of leadership experience with validated capability in guiding and encouraging dedicated teams, collaborating effectively with diverse partners, and portraying Quality Unit as a dependable partner to clients and regulators
Ability to work in an office and manufacturing environment
Occasional travel may be required

Responsibilities

Establish and lead short- and long-term Quality objectives aligned with company goals, PSG & CTD strategy, and site priorities
Serve as a member of the site leadership team, actively shaping business strategy while ensuring compliance is never compromised
Provide mentorship, coaching, and development opportunities to cultivate a hard-working Quality organization
Manage and elevate the site Quality System to align with cGMP, FDA, EMA, and global regulatory standards, ensuring adherence throughout all packaging, labeling, and distribution procedures
Oversee qualification, validation, and equipment/premises maintenance while driving a proactive culture of inspection readiness
Act as the primary Quality representative during health authority and client inspections, mitigating risks and ensuring successful outcomes
Ensure each batch of medicinal product meets applicable legal and regulatory requirements while maintaining transparency with leadership and clients
Partner with Operations, Supply Chain, and Client Services to deliver reliable, Right-First-Time execution of packaging and distribution activities
Drive a culture of proactive compliance, accountability, and continuous improvement
Support business development activities by positioning Quality as a differentiator in client engagements and proposals

Skills

Key technologies and capabilities for this role

GMPQuality ManagementRegulatory ComplianceInspection ReadinessContinuous ImprovementLeadershipClinical PackagingLabelingDistributionClient PartnershipStrategic PlanningMentorship

Questions & Answers

Common questions about this position

What is the work location for this Sr. Manager role?

The position is based at the Mount Prospect, IL location.

What is the salary or compensation for this position?

This information is not specified in the job description.

What key skills and experience are required for the Site Quality Head role?

The role requires seasoned leadership in Quality operations, expertise in cGMP, FDA, EMA, and global regulatory standards, and hands-on experience in compliance, inspection readiness, validation, and continuous improvement.

What does the company culture look like at Thermo Fisher Scientific?

The culture emphasizes meaningful work with global impact, adherence to GMP safety standards, proactive compliance, accountability, continuous improvement, and developing team members through mentorship and coaching.

What makes a strong candidate for this Site Quality Head position?

A strong candidate is a seasoned Quality Leader with strategic and hands-on experience in quality systems, regulatory compliance, inspection management, and cross-functional partnership, capable of serving on the site leadership team.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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