About This Role
Directing quality control operations and providing leadership to the Quality Control teams is the core of this role. The director ensures full compliance with corporate and regulatory requirements while supporting internal departments and external partners, and proactively identifies and mitigates risks to quality control processes.
Responsibilities
- 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
- Supervise 5 subordinates – Manager Quality Control 1
Requirements
- 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
- At least 3 years of experience in the following:
- Working in a regulated pharmaceutical/vaccine manufacturing environment
- Regulatory requirements, inclusive of cGMP/GLP and ensuring compliance with documentation practices, change management, and sample control
- Investigation techniques including providing technical guidance, training, and oversight for testing vaccines in a Vaccine manufacturing environment
- Conducting root cause analysis and identifying, developing, and tracking Corrective and Preventive Actions (CAPA), including in support of audit responses
- Preparation, monitoring, and adherence of departmental budgeting
- Lean/5S/six sigma methodologies
- Laboratory control operations
- Developing and maintaining Standard Operating Procedures (SOPs) and validating, maintaining, and improving analytical chemistry and biochemistry test methods
