Associate Director, Quality Control - Microbiology

Role Summary

Associate Director, Quality Control – Microbiology. Leads the site QC organization focusing on Microbiological Testing and Environmental Monitoring, developing mature laboratory operations with a strong quality and safety culture, and implementing the Quality Management System in the laboratory. Partners with engineering to deliver a state-of-the-art laboratory and ensures timely, reliable laboratory results in compliance with regulatory requirements.

Responsibilities

• 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 ‚Äì 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 through 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.

Qualifications

• Bachelor of Science degree or equivalent in a scientific field (preferably microbiology)
• Minimum of 5 years‚Äô GMP Quality Control Laboratory experience including instrument qualification, microbiological testing, environmental monitoring, and method transfer
• Minimum of 5 years‚Äô leadership experience (ideally in Quality Control) supporting parenteral operations
• Supporting regulatory inspections
• Fluent in English
• On-site presence required

Skills

• 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.
• Experience with Climet instrumentation and MODA.

Education

• As listed in Qualifications

Additional Requirements

• Ability to work overtime as required.
• Available off shift to respond to operational issues.
• The position is for the Kenosha County, Wisconsin site. Onsite presence is required, with a flexible environment allowing remote work no more than 4 days per month depending on project phase.
• Periodic business travel (~10-20%) to support site benchmarking initiatives, training needs and cross-site networking.