Single Use Technology Audit Lead, Quality Systems at Thermo Fisher Scientific

Logan, Utah, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

NoVisa

Biotechnology, Life Sciences, PharmaceuticalsIndustries

Requirements

Bachelor’s Degree in a scientific field or proven experience within Biotech/Pharma quality management systems
Minimum of 2 years in a Quality Management System role
Successfully delivering large and complex improvement initiatives
Certified as a Lead ISO 13485 auditor
Expertise in GMP standards
Proven ability to participate in groups, manage deliverables and establish relationships
Excellent written and oral communication skills: ability to communicate effectively with customers and compose and deliver outstanding presentations
Outstanding interpersonal skills, including collaboration and negotiation
Experience in developing and managing project plans and priorities
Residency near Logan Utah, Millersburg Pennsylvania, Nashville TN or Cramlington UK (onsite position, no relocation assistance)

Responsibilities

Develop and maintain the annual network internal audit schedule
Conduct internal audits and collaborate effectively with cross-functional teams
Lead the network external audit program, ensuring risks are identified and communicated across the business
Assist Customers with quality management system queries
Manage the network desktop audit package to ensure it remains up to date
Maintain external audit procedures and associated documentation
Generate and manage metrics to monitor audit performance across the network
Support the Customer Quality Agreement process
Apply Practical Process Improvement (PPI) to drive continuous improvement in the audit process

Skills

Key technologies and capabilities for this role

auditingquality management systemsregulatory complianceinternal auditsexternal auditsrisk assessmentcross-functional collaborationaudit schedulingdesktop auditsaudit procedures

Questions & Answers

Common questions about this position

What is the work arrangement for this position?

This is an onsite position requiring residency near Logan, Utah; Millersburg, Pennsylvania; Nashville, TN; or Cramlington, UK. No relocation assistance is provided.

What education and experience are required for this role?

A Bachelor’s Degree in a scientific field or proven experience in Biotech/Pharma quality management systems is required, along with a minimum of 2 years in a Quality Management System role, successful delivery of large improvement initiatives, and certification as a Lead ISO 13485 auditor.

What key skills are needed to succeed in this position?

Expertise in GMP standards, proven ability to participate in groups and manage deliverables, excellent written and oral communication skills, outstanding interpersonal skills including collaboration and negotiation, and experience in developing and managing project plans are essential.

What is the company culture like at Thermo Fisher Scientific?

The culture emphasizes impactful work, innovative thinking, and dedication to doing the right thing with the customer top of mind, in a dynamic and collaborative environment within a fast-growing global organization that values passion and unique contributions.

What makes a strong candidate for this Audit Lead role?

Strong candidates will have a Bachelor’s in a scientific field or equivalent experience, at least 2 years in quality management systems, Lead ISO 13485 auditor certification, GMP expertise, and demonstrated skills in communication, collaboration, negotiation, and project management.

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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