Analytical Quality Assurance Lead, Medicines Foundry

Regulatory Jobs; Lebanon (IN); On-site; USD 65,000 - 169,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Life insurance

Job summary

Lilly seeks a Sr. Principal Associate for Analytical Quality Assurance to ensure laboratory activities at the Lilly Medicine Foundry meet global quality standards and cGMP.

You will oversee analytical data generation, reporting, and QC processes, working with external partners and internal teams to maintain a state of control. The role involves design-phase QA oversight, qualification support for analytical methods, and establishing quality management systems for this new facility in Lebanon,

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, or related field with at least 5 years laboratory experience.
• Experience in pharmaceutical quality assurance and highly paced environments.
• Experience with analytical method development and validation.
• Knowledge of GMP and quality management systems.
• Authorized to work in the United States full-time.

Responsibilities

• Provide quality oversight in Analytical testing, namely: molecule and modality support, qualification of new contract labs, audit support, quality system ownership, leading compliance projects for analytical within the Foundry, and quality assessments of quality documentation (e.g., deviations, change records).
• Provide quality oversight of method verification, qualification, and validation activities.
• Ensure that appropriate quality systems are in place and are being utilized. Facilitate quality improvement initiatives, and the implementation of new quality standards.
• When necessary, evaluate potential impact of incidents on quality of materials, or the integrity of data.
• Ensure appropriate investigations are conducted for deviations, stability failures and out of specification (OOS) results. Review and approval of the corresponding documentation.
• Perform Quality Assurance review and/or approval /rejection of GMP documentation and ensure that review/approval by appropriate technical experts has occurred.
• Be available for consultation on quality-related issues as needed.
• Network with Lilly quality organizations in the implementation of quality laboratory systems and share best practices.
• Promote a positive quality culture and oversee quality presence in the respective laboratory areas.
• Identify and lead process improvement projects impacting multiple business areas.

Skills

Analytical method development

Analytical method validation

GMP knowledge

Quality management systems

Laboratory testing experience

Education

Bachelor's degree in Pharmacy, Chemistry, Biology, or related field

5+ years laboratory experience

Job description

Lilly seeks a Sr. Principal Associate for Analytical Quality Assurance to ensure laboratory activities at the Lilly Medicine Foundry meet global quality standards and cGMP.

You will oversee analytical data generation, reporting, and QC processes, working with external partners and internal teams to maintain a state of control. The role involves design-phase QA oversight, qualification support for analytical methods, and establishing quality management systems for this new facility in Lebanon,