Associate Director - Parenteral Drug Product External Manufacturing QA Operations

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.

Responsibilities

Drug Product External Manufacturing Quality Assurance assures patients worldwide of safe and efficacious drug products, through effective quality oversight contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations, and termination.

Drug Product External Manufacturing Quality Assurance is committed to creating partnerships that facilitate open communication and maintaining effective relationships with our alliance partners, contract manufacturers, and internal business customers.

The QA Associate Director position is responsible of the development, management, and continuous improvement of the DPEM quality system through the Quality Assurance team (QA team). Specifically, the QA Operations Supervisor will be responsible for quality activities related to start up and maintenance of parenteral manufactured products and facilities in identified countries.

Key Objectives/Deliverables:

Safety:

·       Support implementation of HSE initiatives and ensure safety goals are achieved.

Contract manufactures management:

·       Support identified Contract Manufacturers (CMs), including Joint Process Team Leader (JPT Leader), Flow Teams and Alliance Management processes as required.

·       Support Corporate audits, CM´s inspections (as required) and follow up on audit findings, ensuring that DPEM are taking appropriate action in due time.

·       Support the development and implementation of harmonized global drug product external manufacturing procedures.

·       Support the communication of Lilly Quality requirements to CMs.

·       Review, revise, and support maintenance of Quality Agreements.

Quality Systems:

·       Support the implementation Quality systems and Q initiatives at CM Level.

·       Support QA Representatives to follow appropriate quality systems. 

·       Support DPEM governance processes including CRB, DRB, Quality Backlog, Site-Self Inspections, Site Quality Lead Team (SQLT).

·       Support implementation of Global Quality Standards, Lilly Quality Standards, Global Contract Manufacturing Standards, and local SOPs for DPEM.

General:

·       Lead the Quality Assurance team including regular contact with remotely located QA team members.

·       Ensure use of Performance Management system for employees in Quality Assurance team, including developing skills and performance of direct reports.

·       Perform notification to management of quality issues as necessary.

·       Respond to requests for data and information from DPEM and CMs.

·       Delegate for Leader of Quality Assurance.

·       Contribute to Business Plan and Long-Range Plan.

·       Approval of technical reports.

Basic Qualification

• Bachelors degree in Biology, Chemistry, Engineering, Pharmacy, or similar technical degree.
• 5+ years of experience in technical and quality functions within a parenteral manufacturing site.
• This position is expected to be in-office in Indianapolis, IN a minimum of 4 days per week with 30% travel to external partners.

Additional Preferences

• Leadership experience within parenteral manufacturing

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

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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