Senior Specialist, Digital & Data Quality

Job description

Job Description The Senior Specialist Digital and Data Quality will be responsible for the quality aspects of GMP computerized systems and the supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations. This includes involvement in all quality-related activities for computerized systems which are required by our Manufacturing Division Quality Manual or with potential for impact on product quality, patient safety or data integrity. The position will work closely with stakeholders and SME’s from site operations, quality operations, IT, automation and engineering to provide evidence of quality oversight throughout the computer system lifecycle and facilitate continuous improvement. The Sr. Specialist DDQ must conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients. Primary Activities include, but are not limited to: As part of the Global Digital & Data Quality team, the Senior Specialist collaborates with stakeholders (e.g., System Owners, Process Owners, Data Owners, Business Unit,...