Quality Project Lead

This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence 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 DescriptionQuality Project LeadDivision / Site Specific InformationWith 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 WorkAs 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 LifeMaintain quality systems in compliance with cGMPs, GxP regulations, ISO standards, global regulatory requirements, and company policiesLead and support investigations related to deviations, nonconformances, and quality events using sound root cause analysis techniquesManage and support CAPA, change control, and risk assessment activitiesAuthor, review, and approve SOPs, investigation reports, and quality documentationConduct and host internal audits, external audits, and regulatory inspectionsAnalyze quality data, perform trending, and report quality metrics to support continuous improvementCollaborate with cross-functional teams to implement corrective and preventive actionsFoster a culture of quality excellence and continuous improvement across the organizationKeys to SuccessEducationAdvanced Degree with a minimum of 3 years of experience ORBachelor’s Degree with a minimum of 5 years of experiencePreferred fields of study: Life Sciences, Engineering, Chemistry, Biology, or related technical disciplineExperienceExperience 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 systemsExperience conducting and hosting internal and external audits and regulatory inspectionsProject management experience preferredKnowledge, Skills, And AbilitiesKnowledgeStrong knowledge of GMP/GxP regulations and ISO standards (9001/13485)Understanding of risk assessment methodologies and continuous improvement toolsSkillsProficiency with quality systems software (e.g., TrackWise, document control systems)Strong technical writing skills for SOPs, investigations, and quality reportsProficiency in statistical analysis, data trending, and quality metrics reportingStrong verbal and written communication skillsAbilitiesAdvanced problem-solving and root cause analysis capabilitiesAbility to work independently and guide cross-functional teamsStrong interpersonal skills with the ability to collaborate across functions and levelsHigh attention to detail and commitment to quality excellencePhysical Requirements / Work EnvironmentAbility to work in a pharmaceutical manufacturing environmentAbility to wear appropriate personal protective equipment (PPE) as requiredBenefitsThermo Fisher Scientific offers competitive remuneration, an annual incentive plan, and comprehensive benefits starting Day 1, including:Medical, Dental, and Vision InsurancePaid Time Off and Designated Paid HolidaysRetirement Savings PlanTuition ReimbursementRelocation assistance is not providedMust be legally authorized to work in the United States without sponsorshipMust be able to pass a comprehensive background check, including a drug screeningThermo 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.]]>