Job Position Overview:The QA Associate Director/Director is responsible for providing leadership, daily support and oversight to qualify and deliver a multi-shift GMP operation capable of producing both commercially approved and late stage investigational aseptically produced radioligand compounds. This position is also responsible for managing the activities of Quality Assurance personnel with respect to record review and release, quality oversight of microbiology and quality control labs, regulatory requirements, procedural interpretation and training, regulatory agency inspections and maintenance of inspection readiness. This role may also support external manufacturing (EM) responsibilities, which includes collaboration partner oversight and lifecycle management.
Responsibilities:- Establish clear Quality Assurance roles and responsibilities and assure QA has proper accept/reject authority
- Establish governance mechanisms to lead staff, assure inter-connectedness between functions, adequate communication, and escalation per local and global procedures
- Assure the Quality Management System is designed, executed, and reviewed for its performance for areas of responsibility, according to global standards and procedures. Lead integration efforts to establish alignment and act as an SME or contact with Global Quality Systems. Develop local procedures and tools for site specific controls and/or unique radiopharmaceutical characteristics.
- Assure controls are established, traceability, and joint team collaboration for the initiation of deviation events. Verify the adequacy of deviation events, the depth of root cause investigations to derive a proper correction or corrective action according to global procedures
- Support the Site Leadership Team in identifying annual objectives, improvement plans, and solutions
- Partner with Technical Services in the design and qualification of new or changing manufacturing processes, their qualification/re-qualification
- Maintain a safe work environment; actively support all HSE Site safety goals/initiatives
- Foster a quality culture that promotes open communication, participation and teamwork
- Supervise, coach, and aid in employee development and performance management; ensure a fair and equitable work environment
- Apply formal technical knowledge of GMP quality systems and aseptic radioligand operations, with an understanding of how Site Quality contributes to the broader business goals
- Make decisions within established Quality, regulatory, and global procedural guidelines, exercising sound judgment across release, deviation, and inspection-readiness activities
- Influence internal and external customers, regulators, and site/global management; collaborate with direct reports and peers to drive impact across close working teams
- Identify and solve a range of organizational, operational, and technical quality challenges affecting site operations, product release, and compliance posture
- Hold management responsibility for broader Quality Assurance teams, including oversight of record review and release, micro/QC labs, and inspection readiness
- Contribute to the development of site and functional business-area plans by forecasting resource needs and managing allocated budget in support of site and global Quality objectives
Basic Qualifications: Candidates must meet the minimum education and experience requirements listed below.
- Bachelor's degree in a science, engineering, pharmaceutical-related field of study or equivalent experience.
- 5+ years in pharmaceutical leadership with specific QA experience, including leading or working effectively with a cross-functional group; experience with RLT (Radioligand Therapy) highly preferred.
Additional Skills/ Preferences:- Strong knowledge of radiopharmaceutical manufacturing and unique controls
- Strong knowledge of Quality Management Systems, Site Compliance processes, and regulatory requirements (e.g., CFRs, EU, ISO)
- Able to interpret traditional pharmaceutical GMPs and appropriately apply practical solutions for radiopharmaceuticals
- Excellent interpersonal, written and oral communication skills
- Strong technical aptitude and ability to train and mentor others
- Strong self-management and organizational skills, ability to prioritize
- Demonstrated problem-solving and decision-making skills
- Regulatory inspection readiness and management experience
- Previous facility or area start up experience
- Proficiency with industry systems including Kneat, Veeva Vault, SAP, manufacturing execution systems, and Microsoft Office products
Additional Information:Indianapolis, Indy RLT (Onsite). Reports to Executive Director, Site Quality Lead. Path/Level: M2/M2-2.
- Position Location: US: Indianapolis IN IRLT
- Travel Percentage (%): As required
- Shift Information: Standard; flexibility required to support site operations
NOTE: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$124,500 - $182,600
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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