Associate Director - QA for QC and Data Stewardship DPEM

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

$118,500 - $191,400

Responsibilities:

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

DPEM QA 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 for Quality Control (QC) and Data Management Supervisor position is responsible of the development, management, and continuous improvement of the DPEM quality system through the Quality Assurance team (QA team). Specifically, this individual will be responsible for quality activities at contract laboratories and data stewardship. This role will also grow in the future to support the expanding commercialization portfolio within DPEM.

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 is taking appropriate action in due time.
• Support the development and implementation of harmonized global DPEM procedures.
• Support the communication of Lilly Quality requirements to CMs.
• Review, revise, and support maintenance of Quality Agreements.

Quality Systems:

• Support the implementation of Quality systems and Q initiatives at the CM Level.
• Support QA Representatives in following appropriate quality systems:  COMTRIX/RIM, TrackWise (for complaints, deviations & change controls), Darwin, SAP
• Support DPEM governance processes including Change Review Board, Deviation Review Board, Quality Backlog, Self Inspections, and 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 QA for QC 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.

Relationships:

• As the Lilly representative, develop professional relationships with all relevant personnel at Contract Manufacturers, as appropriate.
• Lilly Affiliate personnel.
• Lilly TSMS, QA, GQL, GQAAC and other Lilly Manufacturing sites.

Basic Qualifications:

• Bachelor´s degree in Biology, Chemistry, Pharmacy, or similar technical background.
• Minimum 5-7 years demonstrated relevant experience in a regulated manufacturing environment; demonstrated leadership experience within pharmaceutical industry preferred.

Preferences:

• Experience working in GMP Laboratories
• Experience with Darwin, SAP, JMP
• Good knowledge of cGMP, external Regulations and Lilly Quality Systems requirements
• Experience in Production, QC, QA, Technical Services, Engineering, or Regulatory is desirable.
• Previous experience executing within Lilly Quality Systems (deviations, analytical investigations, change, and / or complaints).
• Strong influencing, interpersonal, and teamwork skills.
• Strong self-management and organizational skills, ability to prioritize, critical decision-making skills, problem solving, mentorship and coaching skills. Self-motivation, lead the way for ensuring a fair and equitable work environment.
• Proficiency with computer systems including Microsoft Office products.
• Demonstrate strong oral and written communication.
• Experience with being a mentor, coach and / or giving and receiving feedback.
• Appreciation of cultural diversity.
• Willingness to travel.

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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