Senior Associate, Quality Assurance - Change Management

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.

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 Overview:

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future.  As a result, Lilly is looking for experienced quality assurance associates to support our growth in Alzey, Germany. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

The Senior Associate, Quality Assurance – Change Management serves as the site lead overseeing the site Change Management and Activity Planning program, which is part of the overall Quality Management System (QMS). Change Management and Activity Planning programs enable the organization to provide safe and effective products that meet customer expectations and regulatory requirements.

Responsibilities:

• Maintains responsibility for a safe work environment, leading safety initiatives, and working safely; accountable for supporting all Health, Safety, and Environmental Corporate and Site Goals.
• Leads, mentors, and coaches operations and support personnel on the change management program.

• Facilitates the Site Change Review Board, providing board leadership to drive complete evaluation of proposed changes including evaluation of risk and impact.

• Owns the site Change Management and Activity Planning programs.
• Serves as the site instructor for Change Management and Activity Planning programs including ensuring process compliance through the development of comprehensive procedures, work instructions, personnel qualification, and other process related documentation.
• Works cross-functionally with all area/function owners to manage, evaluate, implement, and document changes to ensure quality, safety, and efficacy of products.
• Monitor the change management program execution ensuring on time approval and closure of change controls.
• Compile, monitor, trend and present Change Management and Activity Planning program health metrics to Site Quality Lead Team and Site Flow Teams with proposed actions.
• Complete change management quarterly reporting.
• Own the change management evaluation section of the Annual Product Reviews.

• Drives Change Management and Activity Planning process improvements using a variety of continuous improvement tools.
• Partners with the global OneQMS team on the design and deployment of the next generation change management program.

• Works with the network peers and global organizations to benchmark and replicate best practices.

Basic Requirements:

• Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.
• Minimum 5 years in the pharmaceutical industry with specific change management experience.
• Fluent in English and German.
• On-site presence required.

Additional Skills/Preferences:

• Demonstrated understanding of cGMP regulations.
• Previous experience in GMP production environments.
• Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing
• Proficiency with applicable computer systems
• Demonstrated experience with the Veeva platform.
• Demonstrated strong oral and written communication skills
• Demonstrated interpersonal skills and the ability to work as a team
• Root cause analysis/troubleshooting skills
• Demonstrated attention to detail and ability to maintain quality systems
• Proven ability to work independently or as part of a Team to resolve an issue
• Technical Writing and Communication Skills
• Previous regulatory inspection readiness and inspection execution experience.

Additional Information:

• Primary location is Alzey, Germany
• Ability to travel (approximately 10-20 %)
• Ability for Short Term Assignment (6-9 Months) in a Parenteral Products Network (PPN) established manufacturing site prior to starting the role

• Ability to work overtime as required.

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 does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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