What are the responsibilities and job description for the Associate Director, Quality- QC Support position at Jobleads-US?
Associate Director, Quality- QC Support
We're creating a healthier world for all people. For over 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and ensure access to these therapies across the globe.
Every member of our team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
Job Description
- Monitor industry practices and relevant regulatory guidance for biological product testing to ensure compliance.
- Review and approve biological test methods and method validation/transfer reports.
- Support biological product sample management and cell bank management.
- Liaise with cross-site QAs and Analytical Leads to resolve issues and improve practices and workflow efficiency.
Responsibilities
- Lead the QA review of analytical data, including data audit trails.
- Manage and train QA specialists on activities related to QA support of analytical activities.
- Participate in authoring, review, and approval of new or revised standard operating procedures.
- Support internal and external audits, site inspection readiness activities, and continuous improvement initiatives.
- Deliver biological GMP training to the QA/QC group.
Qualifications
- Bachelors Degree and 10 years of experience required OR Masters Degree and 8 years of experience required OR PhD and 5 years of experience required.
- Experience with biological method development, verification, validation and transfer required.
- Demonstrated ability to develop, coach and mentor employees.
- Excellent interpersonal, verbal, and written communication skills.
About Us
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people.
