Quality Project Lead

This job is with Thermo Fisher Scientific, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Work Schedule
Standard (Mon-Fri)  Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Quality Project Lead
Division / Site Specific Information   With the support of over 800 talented employees, Thermo Fisher Scientific’s  Oral Solid Dose (OSD) site in Cincinnati, Ohio  provides comprehensive drug development and commercial manufacturing services. The site specializes in advanced dosage forms including controlled and sustained release products, osmotic release dosage forms (laser drilling), liquid-filled hard capsules, controlled substances, and abuse-deterrent technologies.

Discover Impactful Work   As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. In this role, you will help ensure the highest quality standards across our operations, supporting our Mission to enable our customers to make the world healthier, cleaner, and safer. As a  Quality Specialist III , you will collaborate cross-functionally to strengthen quality systems, drive continuous improvement, and ensure regulatory compliance in a highly regulated pharmaceutical manufacturing environment.

A Day in the Life     Maintain quality systems in compliance with cGMPs, GxP regulations, ISO standards, global regulatory requirements, and company policies

Lead and support investigations related to deviations, nonconformances, and quality events using sound root cause analysis techniques

Manage and support CAPA, change control, and risk assessment activities

Author, review, and approve SOPs, investigation reports, and quality documentation

Conduct and host internal audits, external audits, and regulatory inspections

Analyze quality data, perform trending, and report quality metrics to support continuous improvement

Collaborate with cross-functional teams to implement corrective and preventive actions

Foster a culture of quality excellence and continuous improvement across the organization

Keys to Success    Education
Advanced Degree with a minimum of 3 years of experience  OR

Bachelor’s Degree with a minimum of 5 years of experience

Preferred fields of study:
Life Sciences, Engineering, Chemistry, Biology, or related technical discipline

Experience
Experience in quality assurance or quality control within regulated industries (pharmaceutical, biotech, or medical device preferred)

Proven experience with CAPA, deviation management, change control, and quality management systems

Experience conducting and hosting internal and external audits and regulatory inspections

Project management experience preferred

Knowledge, Skills, and Abilities

Knowledge
Strong knowledge of GMP/GxP regulations and ISO standards (9001/13485)

Understanding of risk assessment methodologies and continuous improvement tools

Skills
Proficiency with quality systems software (e.g., Track Wise, document control systems)

Strong technical writing skills for SOPs, investigations, and quality reports

Proficiency in statistical analysis, data trending, and quality metrics reporting

Strong verbal and written communication skills

Abilities
Advanced problem-solving and root cause analysis capabilities

Ability to work independently and guide cross-functional teams

Strong interpersonal skills with the ability to collaborate across functions and levels

High attention to detail and commitment to quality excellence

Physical Requirements / Work Environment     Ability to work in a pharmaceutical manufacturing environment

Ability to wear appropriate personal protective equipment (PPE) as required

Benefits   Thermo Fisher Scientific offers competitive remuneration, an annual incentive plan, and comprehensive benefits starting Day 1, including:
Medical, Dental, and Vision Insurance

Paid Time Off and Designated Paid Holidays

Retirement Savings Plan

Tuition Reimbursement

Relocation assistance is not provided
Must be legally authorized to work in the United States without sponsorship
Must be able to pass a comprehensive background check, including a drug screening

Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization and outstanding career and development opportunities. Our culture is built on integrity, intensity, involvement, and innovation.

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