Senior Director, Quality - Compliance in Alzey bei Lilly

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.

Organization Overview:

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 are looking for people who are determined to make life better for people around the world.

Lilly is designing and building a Next-Generation Parenteral and Device Assembly/Packaging Facility in Alzey, Germany. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site from the ground up. Our new Alzey facility will be one of Lilly’s most technically advanced manufacturing sites and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will result in safety and quality improvements, increased productivity, and variability reduction.

Responsibilities:

Senior Director – Alzey Site GMP Compliance leader & Qualified Person serves as the site compliance officer and management representative with responsibility and authority that includes:

• Ensuring that processes needed for the quality management systems exist and are documented.

• Reporting to top management on the effectiveness of the quality management system and any need for improvement

• Ensuring the promotion of awareness of applicable regulatory and quality management system requirements throughout the site organization.

• Oversees compliance to all cGMP procedures, policies and guidelines.

• Ensures that each batch of medicinal products is produced and controlled in accordance with the GMPs and the marketing authorization.

• Carries out the certification and final release of each batch of finished product.

• Acts as the primary back-up of the Site Quality Leader during their absence

Key Objectives/Deliverables:

• Acts as primary Qualified Person for the medicines processed at the site, therefore ensures that each batch of medicinal products is produced and controlled in accordance with the GMPs and the marketing authorization.

• Carries out the certification and final release of each batch of finished product.

• Decides the need to recall distributed batches from the market with the collaboration from the Site Quality Leader and globally by Lilly Senior Quality Leadership.

• With the support of the Site Quality Leader and the Global Quality Leader, ensures timely reporting of events to regulatory agencies when necessary.

• Approves significant complaints, change controls and deviations.

• Ensure that processes needed for the site quality management system are established and documented. Monitor and report on the effectiveness of the quality management system and needed improvements.

• Ensure awareness of applicable regulatory requirements and quality management system requirements throughout the organization

• Sponsors site initiatives related to quality and compliance; supports network initiatives related to quality and compliance for local implementation; acts as connection for global initiatives related to quality and compliance for local implementation

• Ensures creation, manages and approves the Site Quality Plan and Site Quality Manual and ensures adequate governance of key quality processes at the site (e.g., site quality lead team, management reviews of quality systems, etc.).

• Ensures that adequate site-wide quality governance boards are implemented and provides direction (e.g., site quality lead team, deviation review board, change control review board, etc.)

• Ensure adequate quality oversight for material and supplier management, incoming controls, Laboratory (quality control) activities, complaints, etc.

• Serves as a quality and technical mentor/coach for interpretation and application of regulatory and global requirements for the site personnel.

• Leads and model