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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 Brand Description:

API External Manufacturing (API EM) supports the delivery of Lilly medicines by providing oversight of the manufacturing of Small Molecules, Large Molecule and Peptide APIs at external manufacturing facilities globally.

The Sr. Director – Quality – Small Molecule API EM is the Site Quality Leader for the Small Molecule Plant within the API EM organization and is responsible for all quality activities related to the oversight of Small Molecule APIs for commercial products. They ensure that products are manufactured, tested and released in accordance with marketing authorization requirements and cGMPs and drive continuous improvement to adapt to the business requirements.

The Sr. Director – Quality – Small Molecule API EM is responsible to stay abreast of the changing environment, both internal business priorities and external regulatory expectations, to identify and focus on continuous improvement efforts and changing priorities.

Key Responsibilities:

Site Quality Leader for Small Molecule Plant

The site quality leader (Sr Director – Quality – Small Molecule API EM) is responsible for ensuring that products are manufactured and released in compliance with marketing authorization requirements and GMPs.

The key responsibilities as the Site Quality Leader include the following:

+ Leading the definition of the quality strategy and quality plans for the Small Molecule Plant and aligning with the Site Quality leaders from the Large Molecule and Peptide Plants as well as the broader External Manufacturing organization.

+ Ensuring the Small Molecule Plant operates in accordance with the quality management system for API External Manufacturing.

+ Ensuring staff are qualified and that the required training of all quality personnel is completed and adapted according to need.

+ Ensuring robust control strategies are developed and maintained for the API EM Small Molecule portfolio of products.

+ Ensuring robust batch release execution processes are in place and are being executed, including appropriate evaluation of batch production records.

+ Ensuring appropriate oversight of Contract Manufacturers and Contract Laboratories supporting the Small Molecule portfolio for API EM and that our Contract Manufacturers and Contract Laboratories have effective quality systems in place.

+ Supporting Inspection activities at our Contract Manufacturers and Contract Laboratories as required.

+ Ensuring all required testing is carried out in a compliant manner, including setting of appropriate specifications, development of robust sampling processes and investigating any anomalies.

+ Ensuring the effectiveness of the site’s quality system including execution of the site self-inspection program.

+ Ensuring deviations, OOS and complaints are investigated and resolved.

+ Ensuring appropriate stability data is available to support storage and retest or expiration dating periods.

+ Participating in and approving annual product reviews.

+ Notifying senior management of significant quality related issues.

+ Ensuring the prompt closure of all regulatory commitments.

Member of Small Molecule Plant Lead Team

As a member of the small molecule plant lead team, the Sr. Director – Quality – Small Molecule External Manufacturing API, has the following shared responsibilities with the Operations Leader:

+ Ensuring and monitoring compliance with local regulations and the requirements of GMPs.

+ Authorizing written procedures and other key GMP documents.

+ Participating in management reviews of process performance, product and data quality, and of the quality management system, and advocating continual improvement.

+ Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management,

+ Ensuring the adequacy and effectiveness of the personnel qualification and training program.

+ Approving and monitoring suppliers of material (where owned by Lilly),

+ Approving and monitoring contract manufacturers, GMP service providers, and consultants.

+ Ensuring record retention processes are robust for the Small Molecule Plant.

Key Objectives/Deliverables:

+ Serve as the Site Quality Leader for the Small Molecule EM Plant as a member of the Small Molecule API EM Plant Lead Team. This includes but is not limited to:

+ Ensure site compliance to all cGMPs, procedures, standards, guidelines and regulatory commitments.

+ Support quality related forums (e.g., Technical Review Boards) required to maintain compliance and continuous improvements.

+ Ensure the creation and maintenance of a site Quality Plan and monitoring of metrics to deliver a complaint quality system.

+ Coordinate and oversee regulatory inspections.

+ Review and approve documents supporting manufacturing and quality systems (e.g., procedures, deviations, changes).

+ Build strong relationships with peers in API EM management, as well as key internal customers/partners, and CM partners.

+ Lead organizational and business planning for the Small Molecule Quality organization, aligning with the broader EM Quality organization as required to ensure there are adequate QA resources to support the business, and the plant continues to grow and prepare for the future needs.

+ Lead the API EM Quality team, providing coaching/feedback to develop leaders and team members, including performance management, talent assessments, mentoring, succession planning, and organizational planning.

+ Participate as a member of the External Manufacturing Quality Leadership team, including establishing company strategies/ processes for working with contract manufacturers and contract laboratories, monitoring overall effectiveness of programs and driving enterprise-wide improvements.

+ Establish and improve business processes to provide any necessary interface between the CM's and Lilly's quality systems (e.g., deviations, complaints, change management) via day-to-day interactions and maintaining Quality Agreements.

Basic Requirements:

+ BS or equivalent in a scientific field or engineering.

+ At least 10 years experience in Quality, Technical Services, Operations, Engineering or Regulatory supporting pharmaceutical manufacturing.

+ Experience leading teams.

Additional Preferences:

+ Excellent interpersonal skills and networking skills.

+ Demonstrated strong written and verbal communications skills.

+ Ability to organize and prioritize multiple tasks.

+ Proven strong problem solving and analytical thinking skills.

+ Understanding of statistical tools and analysis.

+ Experience overseeing work at Contract Manufacturers/ Laboratories.

+ Experience leading leaders

+ Ability to influence diverse groups

Educational Requirements:

+ BS or equivalent in a scientific field or engineering.

Other Information:

+ Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.

+ Must carry a cell phone to support 24 hour/day operations.

+ Global Travel is needed (approx 25%)

+ Extended work hours may be required during regulatory inspections, critical production issues or to interact with staff members working shift assignments.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$156,000 - $228,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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