Lead and supervise QC analysts supporting finished product release and stability testing. Ensure compliance with cGMP, FDA regulations, ICH guidelines, and internal quality systems. Oversee laboratory operations including scheduling, resource allocation, and workload prioritization. Provide technical expertise in analytical testing methods (e.g., HPLC, GC, dissolution)Manage and prioritize stability testing programs to meet critical deadlines. Review and approve laboratory data, investigations, and technical documentation. Lead and support OOS, OOT, deviations, and root cause investigations. Mentor, coach, and develop team members to foster a strong quality cultureSupport regulatory inspections and audits, ensuring inspection readiness at all times. Drive continuous improvement initiatives to enhance efficiency, compliance, and data quality. Ensure adherence to data integrity principles and proper documentation practices. Collaborate cross-functionally with Manufacturing, QA, and other stakeholders. Utilize LIMS and quality systems for data tracking, reporting, and compliance. Minimum Qualifications. Education & Experience:Advanced degree with 3 years of relevant experience, or. Bachelor’s degree with 5 years of experience in pharmaceutical/biotech QC - Minimum 2 years of leadership or supervisory experience. Field of Study:Chemistry, Biology, Biochemistry, Microbiology, or related scientific discipline. Preferred Qualifications. Certifications in quality systems, regulatory compliance, or project management. Experience with LIMS and quality management systems. Experience supporting regulatory audits and inspections. Required Skills & Competencies. Strong knowledge of cGMP, FDA regulations, and ICH guidelines. Expertise in release chemistry and stability testing requirements. Proficiency with analytical instrumentation (HPLC, GC, dissolution, etc.)Strong technical writing skills (SOPs, investigations, regulatory documents)Proven leadership and team development capabilities. Excellent problem-solving and root cause analysis skills. Strong organizational and project management abilities. Effective communication and interpersonal skills across all organizational levels. Working knowledge of data integrity and documentation practices. Ability to manage multiple priorities while maintaining high-quality standards. Proficiency in Microsoft Office applications. Flexibility to support manufacturing schedules as needed. Work Environment & Expectations. Operates in a regulated laboratory environment supporting pharmaceutical manufacturing. Requires adaptability to shifting priorities and production timelines. Strong emphasis on quality, compliance, and continuous improvement