Quality Control Director

Your day-to-day will include

• Provide both administrative and technical leadership to Quality Control teams overseeing Chemistry, Virology, Immunochemistry, and other key laboratory functions.
• Manage all quality control operations, to ensure full compliance with corporate and regulatory requirements while effectively supporting internal departments and external partners.
• Provide quality oversight to the Quality Department and site, ensuring compliance with documentation practices, change management, sample control, laboratory systems, and laboratory investigations.
• Support audit responses and ensure timely completion of assigned Corrective and Preventive Action (CAPA).
• Develop and maintain Standard Operating Procedures (SOPs) and training programs related to sample control and accountability.
• Proactively identify and mitigate risks to quality control processes, including analytical chemistry and biochemistry test methods, ensuring their ongoing maintenance, validation, and improvement.
• Implement process improvements to maintain a high-performing, efficient laboratory environment.
• Oversee quality control investigations involving chemical and immunochemical assays by ensuring employee training, reviewing reports for scientific and regulatory compliance, and facilitating cross-functional root cause analysis and CAPA development.
• Supervises 5 subordinates – Manager Quality Control 1.

You have the following technical skills and qualifications

• Requirement – Master’s degree in Biology, Chemistry, Biochemistry, Biopharmaceuticals, or related, or foreign equivalent plus 3 years post-baccalaureate experience in job offered or any related quality control related job titles.
• Relevant experience – Applicants must possess at least 3 years of experience in the following: (1) Working in a regulated pharmaceutical/vaccine manufacturing environment; (2) regulatory requirements, inclusive of cGMP/GLP and ensuring compliance with documentation practices, change management, and sample control; (3) Investigation techniques including providing technical guidance, training, and oversight for testing vaccines in a Vaccine manufacturing environment; (4) Conducting root cause analysis and identifying, developing, and tracking Corrective and Preventive Actions (CAPA), including in support of audit responses; (5) preparation, monitoring, and adherence of departmental budgeting; (6) Lean/5S/six sigma methodologies; (7) laboratory control operations; and (8) Developing and maintaining Standard Operating Procedures (SOPs) and validating, maintaining, and improving analytical chemistry and biochemistry test methods.

Additional information

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