Sr. Principal Associate for Analytical Quality Assurance - Foundry

About the role

Lilly is seeking a Sr. Principal Associate for Analytical Quality Assurance to oversee laboratory activities in the Lilly Medicine Foundry and with external partners, ensuring they adhere to global and site quality standards and cGMP.

Responsibilities

• Provide quality oversight in Analytical testing, including 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).
• Ensure appropriate quality systems are in place and are being utilized.
• Facilitate quality improvement initiatives, and the implementation of new quality standards.
• Evaluate potential impact of incidents on quality of materials, or the integrity of data.
• Conduct appropriate investigations for deviations, stability failures, and out of specification (OOS) results.
• Review and approve 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

• Basic requirements.
• Additional preferences.

Skills

• 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.
• Proven experience 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.

Benefits

The position offers a comprehensive benefit program 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

The anticipated wage for this position is $65,250 - $169,400.

Schedule

Initial location at Parkwood West, Carmel, Indiana. Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.