Plant Quality Leader

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 Plant Quality Leader in Indianapolis Parenteral Manufacturing serves as the leader for the quality assurance organization in one of the plants. They are responsible to lead and develop the QA team. They serve as a Site / Plant agent to manage compliance to all cGMP procedures, policies, and guidelines; support issue resolution, and approve recommendations related to product quality. They work cross-functionally to lead the plant by supporting completion of key initiatives and meeting the business plan as well as enabling and sustaining the site / plant safety, quality, and compliance culture.

Key Objectives / Deliverables:

Team and Personnel Development:

• Participate in Human Resource Development, Human Resource Planning, and Performance Management plans for direct reports, recruit new talent, and grow team capabilities
• Develop individuals and team to ensure continuous professional development
• Sponsor, develop, and support the site Safety, Quality, and Compliance initiatives and culture.

Plant Leadership:

• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
• Support the plant business plan and influence plant agenda to ensure reliable supply of quality medicine, strong quality culture, and maintenance of cGMP compliance and inspection readiness
• Participate actively on the plant lead team, Site Quality Lead Team, functional lead teams, and other governance instances at the plant / site (as appropriate)
• Serve as a conduit for site, network, and corporate communications
• Communicate to and strive for integration of support groups outside plant
• Benchmark and network with other Lilly sites and PR&D for communications and shared learning (best practices, learnings, etc.)

Plant Quality and Compliance Oversight:

• Exhibit critical business decision making taking into consideration quality, compliance, and business aspects, escalate critical quality issues, when appropriate, on a timely manner, and proposing decisions into the escalation forum (e.g., Site Lead Team)
• Create and manage Site Quality Plan; maintain technical and compliance consistency across plants
• Ensure Plant inspection readiness
• Participate and, when needed, coordinate and manage regulatory inspections
• Provide guidance to significant investigations and compliance gaps at site level
• Approve (or reject) technical and quality documents that, per local procedures, require quality director level approval such as major deviations, major changes, L3 complaints, etc. and / or other documents within their areas of responsibility that, per Lilly Quality Standards, might require Site Quality Leader level approval when described in local procedures (this includes approval of Level 3 complaints, major deviations and changes, approval of date extension requests and due date changes, approval of process validation protocols and reports, approval of validation master plans, approval of risk-based rationale if bracketing of products is used for cleaning validation, etc.)
• Ensure adequate quality oversight for manufacturing operations within their plant and areas of responsibility
• Act as primary back-up for other Quality Assurance Directors and, upon delegation of authority, the Site Quality Leader.

Basic Requirements:

• BSc or MSc in scientific or technical degree: chemistry, biology, microbiology, pharmacy, engineering, or equivalent scientific / technical degree.
• 8+ years of experience in pharmaceutical industry with demonstrated successful leadership experience.

Additional Skills / Preferences:

• Good knowledge of cGMP, external…