Sr. Principal Associate for Analytical Quality Assurance - Foundry

About the role

The Sr. Principal Associate for Analytical Quality Assurance ensures that laboratory activities conducted in the Lilly Medicine Foundry and with external partners are carried out in accordance with global and site quality standards and/or are following current Good Manufacturing Practice (cGMP).

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.

Requirements

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field with a minimum of 5 years technical laboratory experience. Quality assurance experience in the pharmaceutical industry, preferred.
• Relevant industry experience in highly paced working environments. Relevant experience of working on large-scale capital project deliveries is highly desirable.
• Strong knowledge of analytical method development and validation.
• Strong knowledge of the current GMP expectations and application of quality management systems in execution.
• Minimum 5 yrs of experience in laboratories and analytical testing.

Qualifications

• Ability to manage in a dynamic environment. Flexibility to adjust quickly and effectively to frequent change and altered priorities.
• Ability to provide input and influence decision making for complex technical issues.
• Proven experience in identifying innovative processes and implementing them with a focus on quality and acceleration.
• Experience with networking across industry, such as with industry groups or committees.
• Success in coaching and mentorship.
• Ability to establish key relationships and influence peers and business partners.
• Strong communication skills.
• Ability to identify and prioritize issues, develop, and implement solutions.
• High learning agility and ability to deal with ambiguity and uncertainty. Capability to drive and design Key Performance Indicators (KPIs), metrics, and data analysis.

Benefits

Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Pay

Initial location at Parkwood West, Carmel, Indiana. Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400.

Schedule

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).