Description

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 39,000 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 Brand Description:

Lilly is a fortune 500 company in operation for over 140 years creating high-quality medicines for our patients while living our company values of Integrity, Excellence, and Respect for People in everything that we do.

Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.

The QA Representative for Site Compliance serves as Quality oversight for evaluating the RTP Quality Management Systems to ensure that processes are robust and in compliance with applicable global medical device and combination product regulations. The QA Representative will develop tools to enable Lilly to better assess the Quality Culture and QMS performance at RTP. The QA Representative will engage in open communication and foster an environment of increased accountability while ensuring that an escalation process is in place.

Key Objectives/Deliverables:

• Support the QA Compliance team and site in the execution of the site readiness plan with focus on supporting start-up of the Audit Management system.
• Create and maintain applicable quality system SOPs
• Develop the RTP site auditing and inspection strategy utilizing a risk-based approach
• Develop and communicate RTP SSI schedule
• Lead/Conduct Site Self Inspections to ensure RTP processes are robust and in compliance with the RTP QMS, ISO 13485 requirements and applicable global medical device and combination product regulations
• Review audit and inspection responses and verify implementation of corrections and CAPA
• Create inspection and audit reports
• Provide support for audits by internal (GQAAC) and external (Notified Body, FDA, tec) auditing bodies
• Facilitate regulatory surveillance of global medical device and combination products regulations. Ensure gap assessment and applicable corrective actions are implemented via RTP site impact analysis process.
• Network with Global Parenteral and Device Network sites as resources and benchmarking sources as applicable.

Minimum Requirements:

• At least 4 years working in the pharmaceutical or medical device industry in Quality or Regulatory Affairs roles.
• In-depth knowledge of applicable external global regulations and ISO 13485
• Experience in audit participation
• Demonstrated strong oral and written communication and interpersonal interaction skills
• Attention to detail and strong organizational skills.
• Demonstrated strong technical writing skills.
• Demonstrated teamwork and interpersonal skills.
• Ability to work 8 hour days - Monday through Friday
• Ability to work overtime as required.
• Ability to travel up to 10% to Indianapolis, IN for meetings and coordination with global regulatory organizations.

Additional Preferences:

• CQA certification from the American Society for Quality (ASQ) and/or Regulatory Affairs Certification (RAC, RAPS)
• Experience with Microsoft Applications, Regulus, SAP, Veeva, and TrackWise

Education Requirements:

• Bachelors degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent industry experience.

Other Information:

• The position is for the Lilly Research Triangle Park site and during the project phase will allow for a flexible working environment with the ability to periodically work remotely based on the project phase and site activities.

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 ( Lilly_Recruiting_Compliance@lists.lilly.com ) 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.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-9909.

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.