Computer Systems Quality Assurance Associate Director Job Description
This position plays a critical role in ensuring the quality and regulatory compliance of biopharmaceutical products within our manufacturing facility. The selected candidate will be responsible for implementing robust data governance practices, executing computer system validation (CSV), supporting laboratory informatics systems, and driving compliance with global regulatory expectations.
Key Responsibilities:
* Quality Systems and Data Integrity: Implement Global CS and DI Quality Standards to the new site.
* Provide Quality Direction: Provide quality direction and governance for QA-owned e-systems, site IT systems, manufacturing systems, and site laboratory systems.
* Data Management and CSV: Develop and maintain quality assurance procedures, policies, and systems related to data management and CSV.
* Self-Inspections and Monitoring Assessments: Conduct routine self-inspections and monitoring assessments to ensure compliance with cGMP, Data Integrity, and other relevant regulations.
Required Skills and Qualifications:
The ideal candidate should have a strong working knowledge of FDA, EMA, HPRA, MHRA, and other regulatory authorities for data integrity, CSV, Quality Risk Management (QRM), and biopharmaceutical regulatory requirements. Proficiency with validation frameworks, risk management, and audit readiness is also essential. Experience with enterprise systems, digital platforms, and automation environments is desirable.
Benefits:
Lilly offers a comprehensive benefits package, including equal opportunities for individuals with disabilities. The company does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, or any other legally protected status.