We are seeking an experienced and highly skilled Quality Control Director with a strong background in molecular biology, particularly in DNA, RNA, and related techniques. The successful candidate will lead and oversee the quality control operations within our biotechnology/pharmaceutical company, ensuring the highest standards of product quality, regulatory compliance, and operational efficiency. This role is crucial in maintaining the integrity of our products and supporting the overall success of our R&D and manufacturing processes.

Key Responsibilities:

• Leadership & Management:
• Lead and manage the Quality Control (QC) team, providing direction, mentorship, and professional development.
• Develop and implement QC policies, procedures, and SOPs to ensure compliance with industry standards, including GLP, GMP, and ISO regulations.
• Collaborate with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to align QC activities with overall company objectives.
• Technical Expertise:
• Oversee the design, validation, and implementation of QC assays and methodologies, focusing on DNA, RNA, and molecular biology techniques (e.g., qPCR, RT-PCR, NGS, sequencing, etc.).
• Ensure the accurate and reliable testing of raw materials, in-process samples, and final products, including nucleic acid-based therapies, diagnostics, or other molecular biology-related products.
• Troubleshoot complex technical issues related to molecular biology assays and processes, providing solutions that maintain high-quality standards.
• Regulatory Compliance:
• Ensure all QC activities are compliant with applicable regulatory requirements (FDA, EMA, ICH, etc.) and quality standards.
• Prepare and review regulatory submissions and audits, ensuring that all documentation meets the required standards.
• Lead internal and external audits, addressing any non-conformances and implementing corrective and preventive actions (CAPAs).
• Continuous Improvement:
• Drive continuous improvement initiatives within the QC department, leveraging new technologies and methodologies to enhance efficiency, accuracy, and productivity.
• Analyze QC data to identify trends and areas for improvement, implementing strategic changes as necessary.
• Stay current with advancements in molecular biology, DNA/RNA technologies, and regulatory requirements, applying this knowledge to optimize QC processes.
• Budget & Resource Management:
• Manage the QC department budget, ensuring cost-effective use of resources while maintaining high standards of quality.
• Oversee the procurement and maintenance of laboratory equipment and supplies necessary for QC operations.

Qualifications:

• Education:
• Ph.D. in Molecular Biology, Biochemistry, Genetics, or a related field. A Master’s degree with extensive experience may also be considered.
• Experience:
• Minimum of 10 years of experience in quality control within the biotechnology, pharmaceutical, or life sciences industry, with at least 5 years in a leadership role.
• Extensive hands-on experience with DNA/RNA techniques, including qPCR, RT-PCR, NGS, and other molecular biology assays.
• Proven track record of managing QC teams and successfully navigating regulatory inspections and audits.
• Skills:
• Strong leadership and team management skills, with the ability to motivate and develop high-performing teams.
• Excellent problem-solving skills, with the ability to troubleshoot complex technical issues.
• In-depth knowledge of regulatory requirements (FDA, EMA, ICH) and quality standards (GLP, GMP, ISO).
• Exceptional communication and interpersonal skills, with the ability to collaborate effectively across departments.
• Strong analytical and data interpretation skills.

Preferred Qualifications:

• Experience with biologics, gene therapies, or nucleic acid-based products.
• Knowledge of automated QC systems and data management tools.
• Experience in a fast-paced, startup or growth-stage company.

Physical Requirements:

• Ability to work in a laboratory setting, including handling of biological samples and operation of specialized equipment.
• Occasional travel may be required for audits, inspections, or conferences.