Senior Associate, Quality Assurance - QA for QC

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 – QA for QC provides quality oversight, assistance, and guidance to the Quality Control Laboratories on issues such as non-conformance investigations, change controls, procedure revisions, method activities (e.g., transfers, verifications, validation), and commissioning and qualification activities.This position is essential for maintaining GMP compliance and ensuring inspection readiness.

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 quality control laboratory personnel on quality matters.
• Supports the QA Compliance team and site in the execution of the site readiness plan with focus on right-first-time execution in the QC Laboratory.
• Reviews and approves laboratory instrument commissioning and qualification deliverables.
• Reviews and approves method deliverables including method transfers, verifications, and validations for QC Lab computer systems and equipment to ensure compliance with quality standards.
• Ensures regular presence in QC Lab areas to monitor GMP programs and quality systems.
• Serves as an active member on local lab team, as outlined in Lilly’s Manufacturing Standards for Operational Excellence, including participation with Lean Lab initiatives, daily huddle board and continuous improvement.
• Assess and triages deviations that occur within Quality Control.
• Works with Lilly support groups and external partners to resolve or provide advice on QC Lab related issues.
• Participates in self-led inspections and provides support during regulatory inspections.
• Works with the Global Quality Control laboratories and network personnel to benchmark and replicate best practices.
• Authors, reviews, and/or approves GMP documents in Quality Control to ensure quality attributes are met (e.g., deviations, procedures, technical studies, validation protocols, change controls).
• Participates in continuous improvement projects to help improve productivity within the local process team or quality organization.

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 Quality Control 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.
• Experience with LIMS, LES, SAP, Veeva Q Docs.
• Six Sigma Green Belt or Lean Training/Experience.
• Proficiency with applicable computer systems.
• 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.
• Computer System Quality Assurance (CSQA) experience.
• Previous use of KNEAT – or other electronic validation software.
• Previous facility or area start up 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.

Lillydoes 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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