Sr. Director, Quality Assurance for Quality Control
USFull-TimeDirector
Salary$229,000 – $268,000
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Job Details
- Experience
- 15+ years
- Required Skills
- Project ManagementQuality Assurance
Requirements
- Bachelor’s degree in Biochemistry, Chemistry, Life Sciences, or a related field.
- 15+ years of relevant industry experience in biotechnology, vaccines, or biologics.
- Deep knowledge of FDA, EU, and ICH regulations and pharmacopeial requirements.
- Strong background in biochemical, immunoassay, or microbiological testing methods within a Quality Control environment.
- Proven experience leading analytical validation, method transfer, and qualification activities.
- Demonstrated ability to build and develop high-performing QA teams.
- Experience managing global teams across multiple sites or countries and establishing consistent GMP standards.
- Strong project management skills with the ability to manage multiple priorities.
- Experience with quality risk management principles and continuous improvement initiatives.
- Experience working with contract manufacturing organizations and external testing partners globally.
- Experience supporting BLA submissions and commercial product launches is highly desirable.
Responsibilities
- Lead QA oversight for Quality Control activities related to analytical methods, validation, qualification, release testing, and in-process testing for drug substances and vaccine components.
- Serve as a key quality partner for internal stakeholders and external organizations, including contract manufacturing organizations and testing laboratories.
- Review and approve GMP documentation, including specifications, certificates of analysis, validation reports, deviations, change controls, risk assessments, CAPAs, and analytical data packages.
- Provide quality guidance on reference standards, analytical methods, protocols, and laboratory processes to ensure compliance with applicable regulations.
- Drive resolution of quality issues, including investigations related to testing deviations, out-of-specification results, and compliance risks.
- Review quality agreements and support regulatory documentation activities, including submissions and responses to health authority inquiries.
- Develop and improve GMP policies, procedures, and quality practices to strengthen organizational compliance.
- Lead and develop geographically distributed QA teams while ensuring consistent quality standards across locations.
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