Senior Digital Quality Assurance Lead - GxP & CSV

Merck; Wilmington (DE); Hybrid; USD 106,000 - 167,000; Full time

Job summary

Merck seeks a Sr. Specialist Digital & Data Quality to drive quality oversight for GMP computerized systems across site facilities, utilities, manufacturing, packaging, labeling and laboratories.

You will ensure compliance with company policies, procedures and regulatory expectations throughout the system lifecycle. You will collaborate with stakeholders from operations, QA, IT, automation and engineering to drive evidence of quality and support continuous improvement, change control, and

Qualifications

• Hands-on experience with automated systems in pharma manufacturing and IT infrastructure.
• Min 5 years of experience in a regulated pharmaceutical manufacturing environment.
• Experience delivering validated IT solutions or supporting validated environments.
• Strong knowledge of 21 CFR Part 11, FDA/EU/ICH regulations and data integrity concepts.

Responsibilities

• Ensure quality oversight of GMP computerized systems throughout their lifecycle.
• Collaborate with site operations, IT, QA, automation and engineering to support compliance.
• Provide independent quality approval of qualification/validation documentation and changes.
• Support regulatory inspections and respond to findings related to IT and manufacturing systems.
• Mentor junior team members and promote continuous improvement in quality practices.

Job description

Merck seeks a Sr. Specialist Digital & Data Quality to drive quality oversight for GMP computerized systems across site facilities, utilities, manufacturing, packaging, labeling and laboratories.

You will ensure compliance with company policies, procedures and regulatory expectations throughout the system lifecycle. You will collaborate with stakeholders from operations, QA, IT, automation and engineering to drive evidence of quality and support continuous improvement, change control, and