Senior Specialist, Quality Assurance

Job Summary The Senior Specialist (Digital & Data Quality) is responsible for the quality aspects of GMP computerized systems and supporting infrastructure across site facilities, utilities, manufacturing, packaging, labeling, and laboratories. The role ensures compliance with company policies, procedures, and regulatory expectations. Key Responsibilities Perform quality-related activities for computerized systems required by the manufacturing division's Quality Manual or that may impact product quality, patient safety, or data integrity. Collaborate with stakeholders and subject matter experts from site operations, quality operations, IT, automation, and engineering to provide evidence of quality oversight throughout the computer system lifecycle and facilitate continuous improvement. Conduct independent, objective work to protect product and patient safety. Ensure technologies meet business needs and promote innovation and efficiency. Interface with Corporate Global IT and internal/external entities to align GxP shopfloor, laboratory, and quality system capabilities with quality policies and objectives. Oversee tailoring of initial project scope to match complexity and risk. Approve qualification/validation documentation, including policies, procedures, acceptance criteria, plans, protocols, specifications, reports, and changes related to computerized systems. Ensure at‑site and abroad system owners have operating level procedures and that systems remain validated, including problem and incident management, change control, periodic review, investigations, backup/restore, and disaster recovery. Review processes and documentary evidence to verify effective compliance activities. Support regulatory inspections and audits; review reports, respond to findings, and take appropriate actions. Resolve regulatory non‑conformance for GxP computerized systems. Communicate system health, compliance, and metrics to stakeholders. Promote GxP awareness and continuous improvement culture. Represent Digital & Data Quality management in meetings related to computerized system selection, operation, and compliance. Develop and maintain training programs on validation, data integrity, ALCOA principles, and system use. Provide quality unit review/approval of SDLC documentation. Mentor and guide junior team members. Qualifications Bachelor’s degree, preferably in Science, Information Technology, Engineering, or an equivalent field. Experience Hands‑on experience with automated systems supporting pharmaceutical manufacturing, IT infrastructure, and/or laboratory operations. Minimum 5 years in a regulated pharmaceutical manufacturing environment. At least 3 years delivering validated IT solutions or in an application support role in a regulated setting. Strong understanding of FDA, EU, and ICH regulations, especially 21 CFR Part 11, 210, 211, and 820, and local regulatory expectations. Extensive knowledge of computerized system validation, compliance principles, theories, and concepts. Experience implementing quality systems in pharmaceutical, laboratory, or biotechnology environments. Limited supervision required for day‑to‑day activities. Preferred Competencies and Skills Professional certifications (e.g., Six Sigma, PMP). Self‑directed team work and priority setting. Understanding of engineering and laboratory standards for system development, implementation, and operations. Quality or compliance experience in a GMP environment. Business engagement and collaboration with technical and non‑technical roles. Multilingual capabilities preferred. Leadership in regulatory inspections. Excellent oral and written communication skills. Analytical problem‑solving abilities. Listening and integrating diverse perspectives. Timely decision making. Project management with a sense of urgency and quality deliverables. Adaptability to changing priorities. Inclusive behaviors and capacity to coach and develop others. Required Skills Adaptability Aseptic Operations Business Continuity cGMP Compliance Computer System Validation (CSV) Data Analysis Data Quality Disaster Recovery Planning Driving Continuous Improvement Environmental Monitoring GMP Compliance Manufacturing Process Improvements Motivation Management Pharmaceutical Manufacturing Pharmacy Regulation Professional Integrity Project Management Quality Auditing Quality Inspections Regulatory Compliance Regulatory Requirements Sterile Manufacturing System Health Monitoring Technical Writing Working Independently Preferred Skills Change Management Continuous Improvement Data Integrity Good Automated Manufacturing Practice (GAMP) Good Manufacturing Practices (GMP) Quality Assurance (QA) System Validation Salary and Benefits Salary Range: $106,200.00 – $167,200.00 Eligible for annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, retirement, paid holidays, vacation, and compassionate and sick days. Full benefit details are available on the company website. Equal Employment Opportunity We are an Equal Employment Opportunity Employer. We provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. Legal Notice We do not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms without a valid written search agreement will be deemed property of the company. #J-18808-Ljbffr Merck & Co. Inc