Sr. Director Quality Control
By KBI Biopharma At , Durham $195,000 - $230,000 a year
Responsible for oversight of contract QC laboratories including routine performance management and participating in audits to ensure sustained quality analytical deliverables.
Must have knowledge of cGMPs and biotechnology-derived product relations. Previous contract manufacturing facility experience is preferred.
Responsible for planning, scheduling and organizing QC activities related to meeting the compliance, supply, profit plan and strategy objectives of KBI.
Responsible for initiation and overseeing projects aimed at cost reduction, efficiency improvements, minimization of downtime and quality and safety enhancement.
Responsible for leadership of method validation of transferred methods.
Responsible for collaborating with cross-functional teams as the Quality Control Subject Matter Expert.
Associate Director, Quality Control
By BioSpace At Concord, NC, United States
Supervise, coach, and aid in employee development and performance management; ensure a fair and equitable work environment
Establish a lab operation compliant with Lilly Global Quality Standards and regulatory requirements, including establishing lab practices, procedures, test methods, etc.
Bachelor of Science in Biology/Microbiology or related work experience
Minimum 5 years of pharmaceutical leadership experience including leading or working effectively with a cross functional groups
Minimum 5 years GMP lab experience including microbiological testing, environmental monitoring, and method transfer
Deep understanding of compliance requirements and regulatory expectations