Associate VP Quality – Global API/ Dry Product External Manufacturing

Eli Lilly and Company; Indianapolis (IN); On-site; USD 234,000 - 344,000; Full time

Job summary

An established industry player is seeking a dedicated Associate Vice President of Quality to lead and enhance their Quality Management systems. This pivotal role involves ensuring compliance and continuous improvement across External Manufacturing processes. The ideal candidate will have extensive experience in GMP operations and quality leadership, with a focus on fostering a culture of excellence. Join a forward-thinking organization committed to making a difference in healthcare, where your leadership will drive impactful change and innovation in quality assurance practices.

Benefits

401(k) plan

Pension

Vacation benefits

Medical benefits

Dental benefits

Vision benefits

Flexible spending accounts

Life insurance

Employee assistance program

Fitness benefits

Qualifications

• 10+ years in GMP Manufacturing operations.
• 5+ years of Quality leadership experience.

Responsibilities

• Lead the design and management of a Quality Management system.
• Ensure compliance with quality initiatives and commitments.
• Serve as liaison with regulatory agencies.

Skills

Leadership

Quality Assurance

Regulatory Compliance

Technical Writing

Interpersonal Skills

Communication Skills

Education

Bachelor’s degree in Chemistry

Bachelor’s degree in Microbiology

Bachelor’s degree in Engineering

Tools

Microsoft Office

Job description

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 around the world 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. We’re looking for people who are determined to make life better for people around the world.

Position Description:

This Associate Vice President Quality – Global API/ Dry Product Network will provide leadership and compliance support to all External Manufacturing for API and Dry Product production. They will have responsibility for the design and management of a single Quality Management system to support the network. The AVP Quality is responsible for ensuring the ongoing robustness and continuous improvement of all Quality and Compliance related systems, activities, and personnel.

Key Objectives/Deliverables:

Personnel development

• Develop QA/QC personnel to ensure that site quality units can maintain a state of compliance with all quality expectations.
• Provide opportunities for people development.
• Participate in recruitment and selection processes.
• Participate in compensation processes.
• Perform evaluations as part of the Lilly’s Performance Management (PM) system.
• Foster a quality culture

Execution of Quality Plan Commitments

• Ensure alignment between corporate and site quality standards and commitments.
• Work with sites to ensure compliance with all quality initiatives and commitments.
• Ensure staff is adequately trained in their roles and responsibilities

Business Process Design

• Lead the design and execution of a single Quality Management system to support the expanding External Manufacturing footprint and encompassing the integration of API and Dry Product Platforms.
• Ensure alignment between corporate and site quality standards and commitments.
• Work with sites to ensure compliance with all quality initiatives and commitments.
• Establish effective and efficient business processes with foster productivity.
• Leverage technology to advance quality within the sites.
• Ensure robust data governance at the sites.

Regulatory Liaison

• Serve as liaison between Lilly and regulatory agencies and provide support to sites during inspections.
• Partner with the sites to maintain a state of inspection readiness
• Ensure coordination and preparation of pre-approval inspections at sites.

Quality Objectives

• Serve as the QA Leader for the API EM Steering team
• Participate in site business and strategic planning
• Design and set goals according to area of responsibility.
• Participate in the development of annual objectives.
• Periodically check the progress of established goals and objectives.
• Notify supervision when goals and/or objectives have or need to change significantly due to business needs.

Requirements (Education, Experience, Training):

• Bachelor’s degree in chemistry, microbiology, engineering, or related discipline
• Minimum of 10 years in a GMP Manufacturing operations
• Minimum 5 years Quality leadership experience and demonstrated ability to manage regulatory communications and inspections.

Preferred attributes but not required:

• Proficiency with computer systems including Microsoft Office products
• Demonstrated technical writing ability
• Demonstrated strong oral and written communication
• Demonstrated interpersonal skills with ability to influence cross-functionally and externally
• Demonstrated ability to maintain a safe work environment

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

$234,000 - $343,200

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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