REQUIREMENTS:

• Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in pharmaceutical/biotech quality control, with 2+ years in a leadership role
• Preferred Fields of Study: Chemistry, Biology, Biochemistry, Microbiology or related scientific field
• Additional certifications in quality systems, regulatory compliance, or project management beneficial
• Strong knowledge of cGMP, FDA regulations, ICH guidelines and quality systems
• Experience with analytical testing methods and instrumentation (HPLC, GC, dissolution testing, etc.)
• Proven ability to lead and develop teams while fostering a quality-focused culture
• Strong technical writing skills for SOPs, investigations, and regulatory documentation
• Experience managing laboratory operations, including scheduling, resource planning and process improvements
• Proficiency with laboratory information management systems (LIMS) and quality management software
• Excellent project management and organizational skills
• Strong interpersonal and communication abilities to interact with all levels of the organization
• Experience supporting regulatory audits and inspections
• Demonstrated problem-solving skills and ability to lead investigations
• Working knowledge of data integrity principles and documentation requirements
• Ability to prioritize multiple responsibilities while maintaining high quality standards
• Experience with risk assessment and root cause analysis
• Proficiency with Microsoft Office applications
• Flexibility to adjust schedules as needed to support manufacturing operations
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