Associate Director, Quality Control - Chemistry

at  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.
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 OVERVIEW:

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality control leaders to support our growth in Alzey, Germany. This is a unique opportunity to deliver on new manufacturing investments and new state of the art QC laboratories.
The Associate Director, Quality Control (QC) – Chemistry, is responsible for leading the site QC organization, specifically operations relating to Chemistry Testing, Device Testing, Stability Administration, Laboratory Informatics and Instrumentation/Equipment Management. This role will partner with the Senior Director, Quality Control, to lead the overall quality control department with a focus on developing mature laboratory operations with a strong quality and safety culture. This leader will implement the Quality Management System in the laboratory and ensure that appropriate capabilities and business processes are developed and sustained. The leader will also partner with engineering to deliver a state-of-the-art laboratory utilizing the latest in automation to further the analytical capabilities of the organization. This position involves working cross functionally within the site and across the network to develop the functional capabilities needed to support the mission of the site. This includes assurance that laboratory results are timely, reliable, and in accordance with regulatory requirements.
The individual in this role must have expertise in Quality Control operations, specifically chemistry test methods, and quality systems. The QC leader must also have demonstrated ability to develop and lead teams and influence across networks and with global organizations.

BASIC QUALIFICATIONS:

• Bachelor of Science degree or equivalent in a scientific field (preferably chemistry)
• Minimum of 5 years’ GMP Quality Control Laboratory experience including instrument qualification, analytical testing, and method transfer
• Minimum of 5 years’ leadership experience (ideally in Quality Control)
• Hosting regulatory inspections
• Fluent in English and German
• On-site presence required

ADDITIONAL SKILLS/PREFERENCES:

• Extensive knowledge and experience with compliance, compendial and regulatory requirements.
• Experience with regulatory inspections and audit readiness, including coaching of personnel and back room/front room support.
• Demonstrated problem-solving and decision-making capability.
• Demonstrated technical writing skills.
• Proven cross-functional leadership and project management experience.
• Excellent verbal communication and presentation skills.
• Previous LEAN experience.
• Experience with electronic laboratory management systems such as LIMS, ELN and LES.

• Work with cross-functional and global teams to drive delivery of full laboratory operations, including method, utilities, and equipment implementation.
• Work with the Senior Director – QC and the Site Quality Leader to support laboratory business and strategic planning to align with company, business unit and site goals.
• Lead talent acquisition initiatives for the laboratory to build a diverse team to support completion of laboratory implementation as well as sustained laboratory growth.
• Ensure all aspects of safety are incorporated into the lab and maintaining a safe work environment, including supporting all HSE Corporate and Site Goals.
• Establish a laboratory operation compliant with Lilly Global Quality Standards and regulatory requirements though development of effective processes and through maintenance and monitoring of laboratory key performance indicators.
• Establish and maintain cross-site network to support alignment of site laboratory practices with global best practices.
• Establish Lean Lab and efficient lab operations with a process for monitoring lab performance and continuously improving the operation.
• Manage laboratory costs, including management of purchase orders, approval of invoices and oversight of laboratory contractors and third-party entities.
• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.
• Lead, coach, and aid in personnel development and performance management.
• Ensure a fair and equitable work environment.
• Lead and oversee regulatory and audit/inspection commitments, including annual product reviews, management reviews and audit/inspection responses.
• Interact with regulatory agencies during inspections regarding cGMP issues.
• Ensure that there are adequate numbers of qualified personnel to perform testing.
• Ensure that people in responsible positions are qualified and have adequate authority to carry out their responsibilities.