Sr. Principal Associate- API EM Quality

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Job description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Position Brand Description:

Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world.

The API EM Quality Sr. Principal Associate provides support to all quality activities at Contract Manufacturing organizations (CMs). The QA Sr. Principal Associate's position is essential for ensuring that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments. The Sr. Principal Associate will need to interact daily with a wide variety of people, primarily external partner's team members and site management.

Key Objectives/Deliverables:

• Serve as a quality liaison between CMs and Lilly.
• Provide quality oversight of CMs including being the initial point of contact for all quality-related issues.
• Escalate quality issues at CMs to Lilly QA management.
• Assist in the establishment and revisions of Quality Agreements with affiliates and customers.
• Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
• Provide quality oversight of Lilly/API-EM Quality Plans.
• Coordinate and perform QA responsibilities of API shipments.
• Participate in regulatory inspection preparations with CMs. Provide on-site support during inspections.
• Participate on the Technical Review Board.
• Evaluate and disposition API batches, if required.
• Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.
• Provide quality support of API manufacturing with the focus on holistic review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures.
• Assess the impact of deviation investigations and changes and ensure that all appropriate records are documented and retrievable.
• Ensure all processes are in an appropriate state of control.
• Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product.
• Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods and computerized system validations.
• Participate in APR activities.
• Participate in projects to improve productivity.
• Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams.

Basic Requirements:

• BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences
• At least 5 years of Previous GMP manufacturing knowledge and/or experience in API or finished product manufacturing

Additional Preferences:

• Experience in quality support for Quality Control activities
• Thorough technical understanding of quality systems and regulatory requirements
• Knowledge of pharmaceutical manufacturing operations
• Demonstrated coaching and mentoring skills
• Experience in root cause analysis
• Demonstrated application of statistical skills
• Demonstrated strong written and verbal communications skills
• Strong attention to detail
• Proficiency with computer system applications
• Excellent interpersonal skills and networking skills
• Ability to organize and prioritize multiple tasks
• Ability to influence diverse groups and manage relationships

Other Information:

• Must complete required training for API EM Quality Assurance
• No certifications required
• Must be able to support 24 hour/day operations which may require support outside of normal working ours
• This is NOT a remote position and requires on-site presence

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

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