Advisor - QA Devices

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 35,000 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 Description:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

The Sr. Director will serve as PDS Management Representative and act as primary liaison with Notified Bodies, FDA and other regulatory agencies as related to devices and combination products. Responsibilities include oversight of ISO/MDSAP/CE certification, PDS management reviews, audits of CMOs, audits of Lilly ISO certified sites, audits of internal support groups, site self-inspections, external regulatory surveillance and management of GMP library.

Key Objectives/ Deliverables:

• As Management Representative, ensure QMS is established, implemented and maintained. Report to executive management on the performance of QMS and any improvements via Management Reviews. Ensure awareness of regulatory requirements throughout the organization
• Maintain PDS ISO 13485/MDSAP certifications and expand scope for new products (e.g., infusion Pumps, MMA/SaMD, electro-mechanical pen-injectors etc.)
• Manage regulatory submissions to Notified Body, maintain CE Marking for medical devices and obtain CE Marking for new medical devices including MMA/SaMD and IVD. Manage and maintain regulatory submissions (NBOp) for drug/device combination products to the Notified Body as per article 117, EU MDR. Network with Device Regulatory group to ensure appropriate device classification and submission strategy. Ensure Technical Files and Design Dossiers are maintained and comply with the current EU harmonized standards listed in OJEC
• Manage regulatory surveillance of global medical device and combination products regulations. Ensure gap assessment and applicable corrective actions are implemented via PDS site impact analysis process
• Serve as Owner of single PDS Quality Manual for the entire devices and combination products network. Ensure adherence to the quality policy and quality objectives for all the ISO certified sites
• Serve as 'Person Responsible for Regulatory Compliance' for Manufacturer with roles and responsibilities as per EU MDR 2017/745 Article 15.
• Expand single ISO certification scope to wet sites (e.g., RTP, Concord) as required
• Mentor, coach and provide feedback to direct reports, team members and cross-functional partners
• Manage the departmental budget as applicable
• Facilitate human resource planning, development, and performance management for direct reports

Minimum Requirements:

• Bachelor's Degree in Science or Engineering (Master's Degree preferred)
• 10+ year's industry related experience in areas which may include Quality, Regulatory, Technical Services, and/or Manufacturing of devices/pharmaceuticals
• 3+ years of experience in a quality leadership position
• Knowledge of global medical device and combination product regulations (e.g., 21 CFR Parts 210/211, 21 CFR 820, 21 CFR Part 4, Canadian MDR, EU MDD/MDR, Japan Ministerial Ordinance 169, TGA Regulations, ANVISA, ISO 13485, ISO 14971)
• Experience with Notified Bodies or other regulatory agencies
• Experience serving as Quality Management Representative
• Experience with ISO 13485, MDSAP and CE Marking certifications

Additional Preferences:

• Experience with Microsoft applications, Regulus, and TrackWise
• Technical knowledge of Quality System elements, design controls, risk management, manufacturing /validation of devices and combination products
• Demonstrated leadership capability and management experience supervising direct and indirect reports
• Demonstrated interpersonal skill for work with cross-functional teams
• Ability to influence diverse groups
• Demonstrated self-management/time-management skills
• Demonstrated decision-making and problem-solving skills
• Coaching and mentoring

Other Information:

• This position requires approximately 5-20% travel.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly