Top 18 Regulatory affairs director Jobs in Cincinnati Oh

Associate Director, QA Global Central Laboratories
Thermo Fisher Scientific —Highland Heights, KY
- Full-time
- 5 years
- Office
- Bachelor's degree
Business Director, DDBP
Cincinnati Children's Hospital —Cincinnati, OH
- $100,526.40 - $130,686.40 a year
- Full-time
- 7 years
- Master's degree
- Bachelor's degree
14d
Regional Sales Business Director, Southeast
Praxis Precision Medicines, Inc. —Cincinnati, OH
- $220,000 - $250,000 a year
- Email
- Remote
- Travel
- Senior level
- Commercial
- AD&D insurance
- Employee stock purchase plan
Quick Apply
14d
Manager, Clinical Operations
Meridian Bioscience, Inc. —Cincinnati, OH
- Full-time
- 5 years
- Bachelor of Science
- Master's degree
Director, Legal
LATICRETE International, Inc. —Cincinnati, OH
- $230,000 - $290,000 a year
- Full-time
- Travel
- Organizational skills
- Senior level
- AD&D insurance
- Paid holidays
Quick Apply
4d
Senior Director, Research & Development – Healthcare Nutrition (Dysphagia Focus)
Lyons Magnus LLC —Walton, KY
- Full-time
- Bachelor of Science
- 11+ years
- Office
- Disability insurance
- Health insurance
Quick Apply
Neuroscience Therapeutic Sales Specialist (Cincinnati, OH)
Compass Pathways —Cincinnati, OH
- $165,000 - $195,000 a year
- Call employer
- Remote
- Bachelor's degree
- Travel
- Senior level
Quick Apply
10d
Regional Director
サイネオス・ヘルス —Cincinnati, OH
- $200,000 - $215,000 a year
- 3 years
- Driver's License
- Bachelor's degree
- Health insurance
- Dental insurance
Supervisory Audiologist
US Veterans Health Administration —Cincinnati, OH
- $131,009 - $170,317 a year
- Online Application
- Acute care
- Background check
- Doctoral degree
Supervisory Physical Therapist (Service Chief)
US Veterans Health Administration —Cincinnati, OH
- $139,680 - $181,589 a year
- Online Application
- Background check
- Writing skills
- Physical & Rehabilitation Medicine
Regional Director
Syneos Health Commercial Solutions —Cincinnati, OH
- 3 years
- Driver's License
- Bachelor's degree
- Health insurance
- Dental insurance
Supervisory Speech Pathologist
US Veterans Health Administration —Cincinnati, OH
- $131,009 - $170,317 a year
- Online Application
- Background check
- Doctoral degree
- Writing skills
Supervisory Occupational Therapist
US Veterans Health Administration —Cincinnati, OH
- $131,009 - $170,317 a year
- Online Application
- Acute care
- Background check
- Doctoral degree
Physician - Physiatrist
US Veterans Health Administration —Cincinnati, OH
- $300,000 - $350,000 a year
- Online Application
- Background check
- Surgery
- Physical & Rehabilitation Medicine
- Paid holidays
- Dental insurance
Physician Nephrology (Transplant)
US Veterans Health Administration —Cincinnati, OH
- $124,308 - $350,000 a year
- 8 hour shift
- Background check
- Medicine
- Management
- Paid holidays
- Dental insurance
14h

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Associate Director, QA Global Central Laboratories

Thermo Fisher Scientific -
Highland Heights, KY

Apply Now

Job Details

Full-time

Qualifications

Data integrity assurance
Regulatory inspections
Risk management compliance audits
Clinical compliance checks
Preventive action implementation
Coaching
Continuous improvement (laboratory quality control method)
Corrective and preventive actions (CAPA)
GMP
Internal investigations
Quality control audit
Clinical laboratory experience
Data integrity and documentation
Key Performance Indicators
Quality risk management
CLIA regulations
Leading team collaboration initiatives
Regulatory readiness in healthcare
Quality control problem-solving
Biomedical regulatory compliance
Clinical research inspection readiness
Operational excellence initiatives
Managing product quality assurance teams
Cross-functional team management
FDA regulations
Audit support
Senior leadership
Quality assurance experience within healthcare

Full Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Associate Director, Quality Assurance – Global Central Laboratories

The Associate Director, Quality Assurance provides strategic and operational leadership for the Quality Assurance team supporting the primary Global Central Laboratories (GCL) site in the Highland Heights, KY/Cincinnati region. This role oversees quality systems supporting clinical laboratory services, biorepository, kitting operations, and related activities while ensuring compliance with regulatory, accreditation, client, and company requirements. The position partners closely with laboratory operations and senior leadership to foster a culture of quality, inspection readiness, continuous improvement, and operational excellence.

Key Responsibilities

Lead, mentor, and develop a team of QA professionals supporting laboratory quality operations.
Oversee quality management systems, including deviations, investigations, CAPA, change control, document control, audits, training, risk management, and quality metrics.
Ensure compliance with applicable regulations and accreditation standards, including CLIA, CAP, ISO 15189, New York State, FDA, EMA, GMP/GLP, and related requirements.
Lead and support internal audits, client audits, regulatory inspections, and accreditation assessments while driving inspection readiness.
Partner cross-functionally to identify quality risks, resolve compliance issues, implement process improvements, and support continuous improvement initiatives.
Monitor quality trends, analyze performance metrics, and provide leadership with recommendations to improve quality, compliance, and operational performance.
Support client interactions, regulatory responses, and quality-related business initiatives.

Minimum Education & Experience

Bachelor's degree (or equivalent) in Life Sciences, Chemistry, Biochemistry, Medical Technology, Clinical Laboratory Science, Quality, Regulatory Affairs, or a related field.
10+ years of experience in Quality Assurance within regulated laboratory, clinical diagnostics, pharmaceutical, biotechnology, CRO, or healthcare environments.
5+ years of leadership or management experience leading QA teams, quality programs, or complex quality initiatives.
Experience with laboratory quality systems, regulatory compliance, accreditation standards, and audit/inspection support. Experience in central laboratories, high-complexity laboratories, biorepositories, or clinical research environments is preferred.

Critical Knowledge, Skills & Abilities

Strong knowledge of laboratory quality management systems and regulatory/accreditation standards, including CLIA, CAP, ISO 15189, NYS, FDA, EMA, GMP/GLP.
Demonstrated leadership experience managing QA teams in regulated laboratory environments.
Expertise in CAPA, investigations, root cause analysis, audit management, inspection readiness, data integrity, risk management, and quality metrics.
Strong understanding of regulatory interpretation, documentation practices, and quality systems.
Excellent leadership, coaching, communication, stakeholder management, analytical, and problem-solving skills.
Ability to lead cross-functional initiatives, manage multiple priorities, and drive continuous improvement in a matrixed environment.
Lean Six Sigma and/or ASQ Quality certifications are preferred.

Apply Now

Refine Your Search

regulatory affairs director jobs in cincinnati oh

Associate Director, QA Global Central Laboratories

Business Director, DDBP

Regional Sales Business Director, Southeast

Manager, Clinical Operations

Director, Legal

Senior Director, Research & Development – Healthcare Nutrition (Dysphagia Focus)

Neuroscience Therapeutic Sales Specialist (Cincinnati, OH)

Regional Director

Supervisory Audiologist

Supervisory Physical Therapist (Service Chief)

Regional Director

Supervisory Speech Pathologist

Supervisory Occupational Therapist

Physician - Physiatrist

Physician Nephrology (Transplant)

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