Quality Manager 

Kelly® Science & Clinical is hiring a Quality Manager in northwest of Dallas, TX for a full-time, direct-hire opportunity with one of our clients who is a leading provider of laboratory testing, regulatory consulting, and certification & audit services in North America. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Direct Hire
Shift: Monday – Friday 8am-5pm
Compensation: DOE 

Position Overview:
We are seeking a proactive and experienced Quality and Safety Manager to lead the strategic development, implementation, and continuous improvement of our QS Management System within a GMP and GLP regulated environment. This role demands adherence to OSHA, state, and industry regulations through comprehensive policies and targeted training for technical and operational staff.

Key Responsibilities:

• Strategically enhance and maintain Quality Management Systems in compliance with GMP, GLP, and relevant regulatory certifications (e.g., USDA, FDA 21 CFR, ISO/IEC 17025).
  

• Perform internal audits to detect quality issues and refine operational processes.
  

• Coordinate and facilitate on-site audits and inspections.
  

• Conduct risk assessments and formulate remediation plans to mitigate potential risks.
  

• Monitor Corrective and Preventive Actions (CAPAs) and change control requests.
  

• Manage the customer complaint process to ensure timely and effective resolution.
  

• Support the Quality team in strategy development, setting objectives and goals, and prioritizing projects.
  

• Ensure all activities align with the Code of Ethics, Quality Assurance, and Health & Safety protocols.
  

• Collaborate with technical departments to ensure compliance with quality standards, and qualify personnel in quality and safety policies and procedures.
  

• Identify training needs and organize interventions to meet quality standards.
  

• Draft, maintain, and distribute policies and procedures.
  

• Promote a culture of safety-first and ensure compliance with Health & Safety policies and procedures.
  

• Generate accident reports and perform trend analysis.
  

• Ensure compliance with hazardous waste management regulations.
  

• Coordinate verification and validation activities in accordance with GLP, AOAC, or FDA standards.
  

• Review documents and records for accuracy and adherence to technical standards.

Qualifications/Requirements:

• A Bachelor’s degree in Chemistry or Health & Safety.
  

• Minimum 5-7 years of management or supervisory experience.
  

• Certified Safety Professional (CSP) certification is highly desirable.
  

• Experience in a Chemistry, Biochemistry, Microbiology, or Quality-driven environment is preferred.
  

• Extensive knowledge of GMP/GLP and OSHA regulations and standards.
  

• Proficient in compendial test methods (USP, FDA, ISO, ASTM, AOAC).
  

• Strong leadership, communication, and technical writing skills.
  

• Proven ability to coach and train team members.
  

• Certification in audit processes.

This role offers the opportunity to shape and influence our quality and safety standards, drive organizational excellence, and ensure the highest levels of compliance and safety within our operations. If you are a dedicated professional with a passion for quality and safety, we encourage you to apply.

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