Manager/Associate Director, Quality and Compliance

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

$96,000 - $162,800

SMDD Overview

Synthetic Molecule Design and Development (SMDD) is comprised of different groups that design and execute the development of all CMC aspects of synthetic molecules from pre-clinical phases through commercialization for drug substances and drug products.

Responsibilities

Through scientific training and relevant experience, the (Associate) Director – Quality and Compliance serves as a key resource for all Quality and Compliance related initiatives within SMDD.

The (Associate) Director:

• Manages key compliance activities which include:
  • SMDD Quality metrics monitoring and management
  • SMDD Quality plan coordinator
  • SMDD Quality Lead Team (QLT) chairperson and coordinator
  • SMDD Trackwise Review Board (TRB) chairperson and coordinator
  • SMDD leader for internal and external quality audits of SMDD
  • SSI and SSA coordinator
  • PRD Controlled Substance Officer, if applicable
  • SMDD functional point person for PRD QS assignments
  • Coordinates Quality System documentation review and approval assignments for SMDD
• Serves as a Trackwise subject matter expert within SMDD and facilitates training for new investigators, change control representatives, reviewers, and approvers
• Leads deviation investigations and change controls in support of the SMDD portfolio
• Coordinates internal and collaboration partner resources for data integrity reviews of large projects (e.g. NDA submissions)
• Liaises with Learning and Development organization to maintain training roles within SMDD and helps supervisors set up training plans for new employees
• Leads continuous improvement initiatives for SMDD including Quality Culture, standards/procedures updates, and deviation/change management processes
• Understands and complies with the PRD Quality System and serves as a business contact for SMDD employees for all Quality and compliance related activities
• Participates in PRD Quality System improvement initiatives as representative from SMDD.
• Implements new systems and technologies that enhance speed and efficiency of meeting PRD Quality System requirements in SMDD laboratories and with our external GMP partners
• Develops tools to visualize, analyze, and understand risks and compliance within SMDD

Minimum Qualification

• B.S. or M.S. in organic or analytical chemistry, engineering, pharmaceutical sciences, information technology, computer science, and related fields; or demonstrated equivalent Quality System and Compliance management experience
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Additional Skills/Preferences

• Ability to prioritize multiple activities and manage ambiguity
• Experience with cGMP manufacturing / process support.
• Strong technical skills to supply business value.
• Excellent verbal and written communication skills.
• Good collaboration skills and ability to work in a team environment
• Knowledge and experience in project management.
• Demonstrated ability to influence project teams and cross-functional partners

Additional Information

Lilly is an EEO/Affirmative Action Employer, and does not discriminate on the basis of race, gender, protected veteran status, disability or any other legally protected status.

Travel:  0 to 10%

Position Local:  Local/Onsite

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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