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Position Brand Description:
The Sr. Director - Quality - API (Peptide) External Manufacturing is the Site Quality Assurance Leader for Peptide products within API EM. The Quality Sr. Director is responsible for ensuring the ongoing robustness and continuous improvement for peptide activities, and personnel at the site. The Quality Sr. Director also ensures that products are manufactured and released in accordance with marketing authorization requirements and cGMPs.
Key Responsibilities:
Establishing and operating a quality management system for API Peptide External Manufacturing
Ensuring staff are qualified and that the required training of all quality personnel is carried out and adapted according to need.
Establishing a batch release process.
Establishing a system to release or reject materials and intermediates.
Ensure the evaluation of batch production records.
Ensure all necessary testing is carried out in a compliant manner.
Approving specifications, sampling instructions and master batch records.
Ensuring robust control strategies are developed and maintained for the API Peptide EM portfolio of products.
Approving and monitoring any analyses carried out under contract, consistent with technical and compliance expectations.
Ensuring that effective systems are used for maintaining equipment and facilities, including contract laboratories.
Ensuring that processes, equipment, utilities, methods and facilities are validated or qualified as appropriate and that related protocols and reports are reviewed and approved.
Ensuring the technical rigor of documentation.
Ensuring effectiveness of the site's quality system including performing self-inspections.
Ensuring quality agreements are in place and maintained.
Ensuring critical deviations, OOS and complaints are investigated and resolved.
Ensuring appropriate stability data to support storage and retest or expiration dating periods.
Participating in and approving annual product reviews.
Notifying senior management of significant quality related issues.
Ensuring timely closure of all regulatory commitments.
Ensuring that information related to the quality of the product is disseminated to those directly responsible for the quality and release of the product.
Authorized members of the quality unit can perform the activities, but the site quality leader maintains ultimate responsibility.
Key Responsibilities shared between the site quality leader and the operations leader:
Ensuring and monitoring compliance with local regulations and the requirements of the GMPs.
Authorizing written procedures and other documents, including amendments.
Ensuring performance and evaluation of in-process controls.
Inspecting, investigation, and taking samples to monitor factors that may affect product quality.
Monitoring and control of the manufacturing and laboratory environments.
Designating and monitoring storage conditions for materials and products.
Validation and qualification activities.
Ensuring the adequacy and effectiveness of the personnel qualification and training program.
Ensuring manufacturing plant hygiene.
Approving and monitoring suppliers of material.
Approving and monitoring contract manufacturers.
Record retention.
Authorized members of the operations or quality unit can perform the activities, but the site quality leader maintains ultimate compliance responsibility.
Key Objectives/Deliverables:
Serve as the Site Quality Assurance Leader to the API Peptide EM Lead Team.
Ensure site compliance to all cGMPs, procedures, standards, guidelines and regulatory commitments.
Support quality related forums (e.g., Technical Review Boards) required to maintain continuous improvements.
Ensure the creation and maintenance of a site Quality Plan and monitoring of metrics to deliver a complaint quality system.
Coordinate and manage regulatory inspections.
Review and approve documents supporting manufacturing and quality systems (e.g., procedures, deviations, changes).
Ensure there are adequate QA resources to support the business and provide coaching/feedback to develop QA employees.
Utilize Human Resources tools to ensure that the right individuals are in the right job (e.g., Performance Management, Merit Delivery, Talent Assessment, Succession Planning and Staffing)
Manage organizational and business planning in QA and participate in the site business plan.
Basic Requirements:
BS or equivalent in a scientific field or engineering.
8+ years QA experience supporting API pharmaceutical manufacturing.
5+ years' experience managing teams
Additional Preferences:
Experience in Manufacturing, Development, QC, Technical Services, Engineering and/or Regulatory Affairs.
Understanding of statistical tools and analysis.
Ability to influence diverse groups.
Demonstrated understanding of computer applications
Excellent interpersonal skills and networking skills.
Demonstrated strong written and verbal communications skills.
Ability to organize and prioritize multiple tasks.
Demonstrated strong problem solving and analytical thinking skills.
Other Information:
This role is based in Indianapolis, IN and remote work is not permitted.
Must carry a cell phone to support 24 hour/day operations.
Global Travel is essential
Role requires frequent intra-site travel.
Extended work hours may be required during regulatory inspections, critical production issues or to interact with staff members working shift assignments.
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 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.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 - $222,200
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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