Quality Assurance Principal Associate

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**:
The QA 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 QA Associate will need to interact daily with a wide variety of people, primarily external partners team members and site management.

**Key Objectives/Deliverables**:

- Serve as a 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.
- Provide quality oversight of Lilly/APIEM Quality Plans
- Coordinate and perform QA responsibilities of API shipments.
- Participate in regulatory inspection preparations with CMs.
- Provide on-site support during manufacturing events and 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, 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.
- Previous GMP manufacturing experience in API manufacturing in a Quality Assurance role (minimum 5 years of GMP QA on the floor support)
- Minimum 10 years of experience in a Quality Assurance role in “big pharma” as the Market Authorization Holder for non-generic products.
- Demonstrated foundational knowledge of ICH and EMA regulations.
- Experience participating in internal, customer, and regulatory inspections
- Process Validation and Technical Transfer experience
- Fluent in English
- ** Additional Preferences**:

- Demonstrated coaching and mentoring skills.
- Experience in root cause analysis.
- Demonstrated strong written and verbal communications skills.
- Strong attention to detail.
- Excellent interpersonal skills and networking skills.
- Ability to organize and prioritize multiple tasks.
- Ability to influence diverse groups and manage relationships.

**Education Requirements**:

- BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
- Master of Science preferred

**Other Information**:

- Must complete required training for API EM Quality Assurance.
- No certifications required.
- Required onsite 2-3 days a week and must be able to support 24 hour/day operations.
- Some travel (