Sr. Director - Quality - API External Manufacturing positions in both Large Molecule & Peptides!

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Sr. Director - Quality - API External Manufacturing positions in both Large Molecule & Peptides!

The Sr. Director - Quality - Large Molecule or Peptides API External Manufacturing is the Site Quality Leader for Large Molecule or Peptides products within API EM.

The successful candidates will be responsible for ensuring the ongoing adaptability and continuous improvement for Large Molecule or Peptide activities, and personnel at the site.

They will ensure 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 External Manufacturing
• Ensuring staff are qualified and that the required training of all quality personnel is completed and adapted according to need.
• Establishing a batch release process.
• Establishing a system to release or reject materials and intermediates.
• Ensuring the evaluation of batch production records.
• Ensuring all essential 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 EM portfolio of products.
• Authorizing and overseeing 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 accuracy of documentation.
• Ensuring the efficiency of the site's quality system including performing self-inspections.
• Ensuring quality agreements are established 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.
• Coordinating and approving annual product reviews.
• Notifying senior management of significant quality related issues.
• Ensuring the prompt 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.

Key Responsibilities shared between the site quality leader and the operations leader:

• Ensure compliance with local regulations and GMP requirements.
• Authorize and amend written procedures and documents.
• Oversee in-process controls and evaluate performance.
• Inspect, investigate, and sample to monitor product quality.
• Monitor and control manufacturing and laboratory environments, including storage conditions.
• Validate and qualify activities, ensuring effective personnel training and plant hygiene.
• Approve and monitor suppliers and contract manufacturers, and manage 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:

• Serve as the Site Quality Assurance Leader to the 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 oversee 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 mentorship/feedback to develop QA employees.
• Embrace 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)
• Lead organizational and business planning in QA and participate in the site business plan.

Basic Requirements:

• BSc or equivalent in a scientific field or engineering.
• Significant QA experience supporting API pharmaceutical manufacturing and experience managing teams.

Additional Preferences:

• Experience in Manufacturing, Development, QC, Technical Services, Engineering and/or Regulatory Affairs.
• Excellent interpersonal skills and networking skills.
• Demonstrated strong written and verbal communications skills.
• Ability to organize and prioritize multiple tasks.
• Proven strong problem solving and analytical thinking skills.
• Understanding of statistical tools and analysis.
• Ability to influence diverse groups.

Other Information:

• Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.
• Must carry a cell phone to support 24 hour/day operations.
• Global Travel is needed
• 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.

These positions are based on site in the US or Europe.

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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