Senior Specialist, Quality Assurance

The Sr. Specialist Digital and Data Quality ensures the quality of GMP computerized systems and supporting infrastructure used throughout site facilities, utilities, manufacturing, packaging, labeling, and laboratories. The role guarantees compliance with company policies, procedures, and regulatory expectations, and provides evidence of quality oversight throughout the computer system lifecycle. Responsibilities Collaborate with system, process, data, and business owners to assess and remediate legacy systems and evaluate/implement new computerized systems that support GxP business processes. Ensure selected technologies meet high-level business needs while encouraging innovation and efficiency. Interface with Corporate Global IT and other internal and external entities to align GxP shopfloor, laboratory, quality system, and infrastructure technology capabilities with quality policies and objectives. Provide independent quality approval of key qualification and validation documentation (policies, procedures, acceptance criteria, plans, protocols, specifications, reports, and system change requests) to ensure compliance throughout the system lifecycle. Confirm that at‑site and above‑site system owners maintain and follow operating level procedures and plans to keep systems validated, including incident management, change control, periodic review, investigations, backup/restore, disaster recovery, and business continuity. Review processes and supporting documentary evidence to verify compliance activities related to computerized systems are effective. Support regulatory inspection and audit activities, including reviewing audit or inspection reports and responding to findings related to IT applications, automated manufacturing equipment, and laboratory systems. Drive the resolution of regulatory non‑conformance for GxP computerized systems and monitor system health and compliance metrics. Promote GxP awareness and a culture of continuous improvement, facilitating manufacturing process improvements and laboratory operational excellence. Represent Digital & Data Quality management at local site or system‑specific meetings regarding computerized system selection, operation, and compliance. Contribute to the development and maintenance of training programs on system validation, data integrity, and regulatory requirements. Mentor and guide junior team members. Qualifications Bachelor’s degree in Science, Information Technology, Engineering, or a related field. Minimum 5 years of experience in regulated pharmaceutical manufacturing and at least 3 years delivering validated IT solutions or application support in a regulated environment. Hands‑on experience with automated systems supporting pharmaceutical manufacturing, IT infrastructure, or laboratory operations. Strong understanding of FDA/EU/ICH regulations (21 CFR Parts 11, 210, 211, 820) and local regulatory expectations. Extensive knowledge of computerized system validation principles and compliance concepts. Familiarity with implementing quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment. Ability to work independently with limited supervision. Preferred Competencies and Skills Professional certifications (e.g., Six Sigma, PMP). Self‑directed team player with strong prioritization and multi‑project management skills. Knowledge of engineering and laboratory standards related to computerized system development, implementation, and operations. Business engagement, cross‑functional collaboration, and communication skills. Analytical problem‑solving and decision‑making ability. Experience leading conversations during regulatory inspections. Continuous improvement mindset and change management knowledge. Experience with GAMP, GMP, and data integrity principles. EEO Statement We are an Equal Employment Opportunity Employer and we provide equal opportunities to all employees and applicants for employment. We comply with all affirmative action requirements for protected veterans and individuals with disabilities. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. #J-18808-Ljbffr MSD Malaysia