Quality Assurance Associate Director (M2)
Company: Eli Lilly and Company
Location: Raritan
Posted on: June 27, 2025
|
|
|
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-DNI Position 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-DNI Job 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.
Keywords: Eli Lilly and Company, Fairfield , Quality Assurance Associate Director (M2), Science, Research & Development , Raritan, Connecticut
