At Lilly, the business problem is to ensure the quality of externally manufactured Peptides and Intermediates, and to maintain compliance with cGMPs and regulatory expectations.
Requirements
- In-depth knowledge of cGMPs and regulatory expectations
- Ability to influence and lead diverse groups
- Influences complex regulatory, business, or technical issues within the site and function
- High attention to detail and a commitment to quality and compliance
- Proficiency in delivering highly complex tasks and/or tasks that are highly cross-functional
- Demonstrated Project Management skills and ability to coordinate complex projects
- Strong analytical and quantitative problem-solving skills, with a proactive approach for identifying and addressing challenges
Responsibilities
- Make decisions regarding the quality of batches, resolution of quality issues and quality performance for partners.
- Lead the API EM QA team, providing coaching/feedback to develop QA employees, including performance management, talent assessments, mentoring, succession planning, and organizational planning.
- Establish and improve business processes to provide any necessary interface between the CM's and Lilly's quality systems (e.g., deviations, complaints, change management) via day-to-day interactions and maintaining Quality Agreements.
- Support API EM' s efforts to maintain and improve our quality systems and ensure alignment with Lilly Global Quality Standards and regulatory agency expectations.
- Coordinate quality activities for outsourcing of Lilly's targeted projects to CMs, including maintaining and improving compliant oversight practices.
- Support regulatory agency inspections at the CM, provide management status updates and participate in the resolution of regulatory findings by coordinating CM and Lilly responses.
- Ensure adequate oversight and excellence for investigations and complaints.
Other
- Bachelor’s Degree (Preferred: Degree in Chemistry, Biology, Biotechnology, Pharmacy, or Engineering)
- Minimum of Five years experience in pharmaceutical manufacturing or development environment
- 10 – 20% travel may be required
- Some off-shift work (night/weekend) may be required to support 24/7 operations across global supplier network
- Proven leadership, administrative and organizational skills
