Associate Director-Quality-Indianapolis Device Manufacturing Device Quality Cont
BioSpace, Inc., Indianapolis
Overview
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 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. Were looking for people who are determined to make life better for people around the world.
Responsibilities
- Provide leadership of IDM Device Quality Control Lab
- Mentor, coach and provide feedback to team members and cross-functional partners
- Ensure an adequate number of qualified resources are available to perform quality control activities in support of IDM QC Lab customers
- Ensure adherence to the quality policy and objectives for the site
- Provide technical understanding and internal/external communication (throughout various functions and organization levels) regarding the Quality Management System to ensure ongoing management of quality system requirements in order to maintain compliance and drive continuous improvement activities
- Participate in and respond to regulatory agency and self-inspections
- Review/approve or reject procedures and training, technical protocol and reports, laboratory methods, change proposals, non-conformances and ensure implementation of appropriate corrections/CAPA and effectiveness checks
- Participate in organizational and business planning activities
- Exhibit cross-functional influence
- Identify barriers to productivity within the unit operation and drive continuous improvement
- Support Method Transfers to Internal Lilly Sites and Contract Manufacturers
- Provide Management support to the internal Spec Management process in organizational and business planning activities
- Perform Site QC approval for laboratory investigations
- Other duties as required
Basic Requirements
- Bachelors degree in Engineering, Medical or Life Sciences
- Minimum of five (5) years industry related experience in areas which may include Quality, Technical Services, and/or Manufacturing
- Demonstrated leadership capability
- Demonstrated interpersonal skills for work with cross-functional teams
- Ability to influence diverse groups
- Demonstrated oral and written communication
- Demonstrated self-management/time-management skills
- Meets commitments and deadlines
- Demonstrated decision-making and problem-solving skills
- Ability to work as part of a team
- Negotiating, mentoring
Additional Preferences
- Knowledge of governing standards and regulations (e.g., 21CFR Part 4, Part 11, Parts 210/211, Part 820 QSR, ISO 13485, ISO 14971, Canadian MDR, EU Medical device Directive, JPAL)
- Regulatory inspection experience
- Technical knowledge in Quality System elements, devices, design, manufacturing and commissioning and qualification
Equal Opportunity and Accommodation
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 for further assistance. 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.
Compensation and Benefits
Actual compensation will depend on a candidates education, experience, skills, and geographic location. The anticipated wage for this position is $118,500 - $173,800. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). Lilly offers a comprehensive benefits program to eligible employees, including medical/dental/vision and prescription benefits, 401(k) eligibility, pension, vacation benefits, flexible spending accounts, life insurance and death benefits, and various well-being benefits.
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