Senior Associate, Quality Assurance – Data Steward (m/w/d)

Senior Associate, Quality Assurance – Data Steward (m/w/d)

The Senior Associate, Quality Assurance – Data Steward is responsible for improving business processes and supporting customer service interactions to ensure key business objectives are met. The role represents Quality Assurance on projects, including Six Sigma, and involves SAP master data management, change management, deviation management, procedure management, specification management, review and approval of cGMP documents, and maintaining regulatory compliance.

Responsibilities

• Support the site in the development and execution of the site readiness plan, focusing on startup of new systems and oversight of the establishment of site master data.
• Support the implementation, validation and maintenance of the software‑based computerized quality systems for the site.
• Serve as the Power User for IT systems supported by QA including LIMS, Manufacturing Execution System (PharmaSuite), SAP, TrackWise, and Veeva Suite.
• Create and manage quality master data in SAP, including q‑info records and inspection plans for materials.
• Protect the integrity and accuracy of data entered into the quality systems, perform data identification and reviews as required.
• Lead, mentor and coach site personnel on the quality systems.
• Responsible for site compliance area documents, including specifications and procedures.
• Partner and build relationships with Global Quality Network and Global IT team members.
• Provide oversight and support continuous improvement of quality systems.
• Support onboarding of new materials in TrackWise.
• Effectively review and approve GMP documents to ensure quality attributes are met (e.g., deviations, procedures, protocols, specifications, change controls).
• Participate in self‑led inspections and/or provide support during internal inspections.
• Support regulatory inspection activities as needed by providing documentation and SME support.

Basic Requirements

• Bachelor’s degree in a science, engineering, or pharmaceutical‑related field or equivalent experience.
• Minimum 5 years in the pharmaceutical industry with specific data stewardship experience.
• Fluent in English and German.
• On‑site presence required.

Additional Skills & Preferences

• Demonstrated understanding of cGMP regulations.
• Previous experience in GMP production environments.
• Proficiency with applicable computer systems including SAP, Trackwise, and Veeva.
• Strong oral and written communication skills.
• Interpersonal skills and ability to work as a team.
• Ability to influence internally and externally.
• Root cause analysis/troubleshooting skills.
• Attention to detail and ability to maintain quality systems.
• 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.
• Knowledge of operations business processes such as batch disposition, materials management, laboratory specification/method management.
• Previous experience with SAP or other inventory management systems.
• Previous experience with device and parenteral product materials.

Additional Information

• Primary location: Alzey, Germany.
• Ability to travel (approximately 10%).

Benefits

• Pioneering spirit: Grow as part of a team that may reach up to 1,000 colleagues within the next three years.
• Innovation: Work in a high‑tech production facility with advanced technology.
• Creative freedom: Contribute ideas and implement them in cross‑functional teams from the beginning.
• Professional development: Access to the Corporate Lilly University for career growth.
• Financial benefits: Attractive salary, company pension plan and other individual benefits.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. 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.