Senior Director - Drug Product External Manufacturing - Quality Assurance

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.

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

Responsibilities:

The Senior Director, Drug Product External Manufacturing (DPEM) - Quality Assurance (QA), provides leadership of the group accountable for all quality activities related to the oversight of North, Latin and South American contract manufacturers (CMs). This includes management of the supporting quality management system and oversight of the final quality of the products released to the market.

Key Objectives / Deliverables:

Quality Execution, Monitoring & Continuous Improvement:

• Ensure DPEM and CM compliance with Good Manufacturing Practices (cGMPs) and Quality Standards, including validation, change control, deviations, complaints, APRs, Quality plan, Self-Assessment, Quality agreement, good documentation practices and SOPs.

• Establish and maintain relationships with third parties and alliance partners to influence execution of regulatory requirements and Lilly quality systems.

• Ensure that an effective quality governance process exists to oversee external manufacturers. This may be different depending on the scope, complexity, and risk at a specific manufacturer.

• Establish metrics, collect, and analyze data, and actively monitor CM performance trends to identify potential safety and quality risks.

• Ensure inspection readiness at all times by coordinating internal and external audits; providing support to CMs as needed.

• Make decisions as regards quality of batches; resolution of quality issues (approval/rejection / rework /refinishing), quality of partners (recommendation of approval or rejection).

• As Management Representative per 21 CFR 820.20, ensure the quality systems requirements are effectively established, maintained, and communicated; and ensure reporting on the performance of the quality systems to management with executive responsibility.

• Advise, support and influence decisions relating to new business development deals to ensure quality matters are appropriately considered.

• Be an active member of the DPEM Lead team, involved in leading the team, driving excellence and continuous improvement.

• Develop the functional Business plan and participate in the DPEM BP consolidation. Ensure the BP implementation within the established targets.

Leadership / Supervision:

• Allocate resources and ensure systems are in place to appropriately oversight and support, external partnerships and associated activities are conducted in a timely fashion and adhere to quality standards.

• Ensure the organization has the necessary capabilities to fulfil its mission, periodically assess gaps and establish plans to close them. 

• Ensure employees have clear, actionable, and measurable objectives in alignment with the DPEM BP and functional objectives and with the Team Lilly expectations. Oversee the performance management and provide timely feedback.

• Define development plans for each direct report and periodically discuss progress. Discuss career goals with each individual and establish career plans. Provide coaching based on individual needs. Continuously evaluate, train, mentor and coach personnel focusing on succession planning and ongoing performance improvement.

• Support the team in minimizing risks and dealing with any concerns or issues effectively.

Basic Qualifications:

• Bachelor's or advanced degree in a science related field such as Engineering, Pharmacy, Chemistry, Biological Sciences, or related Life Sciences.

• Minimum of 10 years’ experience in drug product pharmaceutical manufacturing including commercialization of new products, with at least 5 years of experience in Quality roles.

• Must have technical understanding and demonstrated application of cGMPs and Global Quality Standards to parenteral manufacturing, drug/device combination products, and packaging.

• Management experience, inclusive of administrative responsibilities (e.g., resource and budget management) and coaching/developing personnel.

Additional Skills / Preferences:

• Strong leadership, cross-functional teamwork, and ability to influence internal and external stakeholders globally. 

• Experience in developing quality management plans, systems, and strategies in compliance with international regulations and industry standards.

• Experience in oversight of third parties, including establishment and management of Quality Agreements and quality performance indicators, and strategic partnership in management of issues.

• Good written and oral communication and critical decision making/problem-solving skills.

• ​Experience in direct interactions with U.S. and international regulatory authorities.

• Demonstrated ability to develop and successfully implement strategies for process optimization initiatives.

Additional Information:

• Position is located in Indianapolis, Indiana, USA

• Shift is days, but off-hours may be necessary to support operations.

• Periodic travel, up to 30%.

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 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.

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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