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Associate Director - Quality Assurance - API EM
BioSpace, Inc.
- United States
- United States
About
Join to apply for the Associate Director Quality Assurance API EM role at BioSpace. 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, with 39,000 employees worldwide. Our mission is to discover and bring life?changing medicines, improve disease management, and give back through philanthropy and volunteerism. We put people first and are looking for determined individuals who want to make a difference. Responsibilities Make decisions regarding the quality of batches, resolution of quality issues, and quality performance for partners. Lead the API EM QA team, providing coaching, feedback, performance management, talent assessments, mentoring, succession planning, and organizational planning. Build relationships with API EM management, key internal customers/partners, and strengthen CM alliances. Establish and improve business processes to interface between CM's and Lilly's quality systems (e.g., deviations, complaints, change management), maintaining Quality Agreements. Support API EMs efforts to maintain and improve quality systems and ensure alignment with Lilly Global Quality Standards and regulatory agency expectations. Coordinate quality activities for outsourcing Lilly's targeted projects to CMs, maintaining and improving compliant oversight practices. Support regulatory agency inspections at the CM, provide management status updates, and participate in the resolution of regulatory findings by coordinating CM and Lilly responses. Ensure adequate oversight and excellence for investigations and complaints. Network globally to share best practices, rationale, and strategies to ensure harmonization and alignment between sites.
Qualifications
Bachelors Degree in a scientific discipline such as Chemistry, Biology, Biotechnology, Pharmacy, Engineering, or related field. 8+ years of experience in pharmaceutical manufacturing environment in TSMS, Production, Quality Assurance, Quality Control, Engineering, or Regulatory Affairs.
Additional Skills/Preferences
Responsible for maintaining a safe work environment. Proven leadership, administrative, and organizational skills. In?depth knowledge of cGMPs and regulatory expectations. Ability to influence and lead diverse groups. Influences complex regulatory, business, or technical issues within the site and function. High attention to detail and a commitment to quality and compliance. Builds relationships with internal and external customers and partners. Proficiency in delivering highly complex tasks and/or tasks that are highly cross?functional. Demonstrated project management skills and ability to coordinate complex projects. Strong analytical and quantitative problem?solving skills, with a proactive approach for identifying and addressing challenges. Ability to communicate and influence effectively across functional groups and stakeholders. Strategic thinking and ability to balance short?term needs with long?term business evolution. Enthusiasm for changes, team spirit, and flexibility. Demonstrated ability to learn and apply technical/scientific knowledge.
Additional Information
1020% travel may be required. Some off?shift work (night/weekend) may be required to support 24/7 operations across global supplier network. This role is based onsite in Indianapolis, IN and is not approved for remote work.
Location
Indianapolis, IN Compensation
Actual compensation will depend on a candidates education, experience, skills, and geographic location. The anticipated wage for this position is $123,000 $198,000. Benefits
Full?time equivalent employees will also be eligible for a company bonus (depending, in part, on company and individual performance). Lilly offers a comprehensive benefits program, including eligibility to participate in a company?sponsored 401(k), pension, vacation benefits, medical, dental, vision, and prescription drug benefits; flexible benefits such as healthcare and/or dependent 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 the companys compensation practices and guidelines will apply regarding promotion or transfer of employees. Accommodations
Lilly is dedicated to helping individuals with disabilities actively engage in the workforce. 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. EEO Statement
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. #J-18808-Ljbffr
Languages
- English
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