Quality Assurance Associate Director (M2) Position Available In New York, New York
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Job Description
Eli Lilly and Company seeks a Quality Assurance Associate Director (M2) to provide quality direction for complex day to-day quality activities and technical challenges ensuring GMP compliance. Partner with the business to resolve critical and complex compliance issues, remove barriers as they arise, and oversee data integrity for paper based and electronic systems, including quality review of audit trail reviews. Oversee the implementation of risk-based strategies. Ensure data compiled are communicated in relevant forums and escalate compliance issues/concerns to Quality senior management. Prepare laboratories for regulatory inspections, support regulatory and business partner inspections/audits, and coordinate inspection/audit responses and commitments. Monitor workload for staff and re prioritize as needed to ensure completion of all tasks. #LI-DNIPosition requires a Bachelor’s degree in Chemistry, Biology, Computer Science, or a related STEM field followed by 5 years of progressively responsible experience with quality assurance or quality control in the pharmaceutical or biopharmaceutical industry. Experience must include a minimum of: 5 years of technical experience in a GMP-regulated environment; 5 years of experience promoting data integrity and compliance; 5 years of experience with applying knowledge of computer systems validation per cGMPs and System/Software Development Lifecycle concepts; 5 years of experience providing oversight on contract lab operations, reviewing laboratory results, and ensuring samples meet testing acceptance criteria and regulatory limits; 5 years of experience leading operational excellence initiatives; 5 years of experience providing guidance on Data Life cycle Management; and 5 years of experience with Microsoft applications and quality systems. Up to 5% domestic and international travel required. #LI-DNIJob location: Branchburg, NJ.
RATE OF PAY
$184,080.00 – $189,072.00 per year. To apply, please visit https://jobsearch.lilly.com/ and enter job requisition number R-88222 when prompted. Alternatively, please send your resume, cover letter, and a copy of the ad to: Matthew Tenaglio, Lilly Corporate Center, Indianapolis, IN 46285.
Minimum Salary:
184,080
Maximum Salary:
189,072
Salary Unit:
Yearly
