Senior Specialist Quality Assurance

Job Overview The mission of Quality Assurance is to safeguard the rights and well‑being of patients and animals, comply with applicable global regulatory requirements through sound processes and procedures, and provide independent assurance that delivers high quality data and clinical supplies. This Senior Specialist, Quality Assurance: Principal Quality Auditor role reports to the Director, Global Clinical Supplies Quality and is critical to maintaining the global clinical supply chain via disposition activities for clinical finished goods provided by our company for worldwide clinical trials. Responsibilities Evaluation and disposition of clinical supply materials to ensure conformance with all applicable policies/procedures and governing regulations. Coordinate and support the preparation of procedures, processes, and quality improvements. Lead projects to improve process performance, including continuous process improvements, investigations, Corrective/Preventive Actions (CAPAs), and value‑capture projects that reduce cost or shorten cycle times. Collaborate cross‑functionally and across business areas to build robust processes and teams. Assist in coordinating significant quality events such as fact‑finding investigations, clinical quarantine and recovery actions. Provide on‑the‑floor coaching and guidance of operational and technical issues; resolve deviations immediately. Manage investigations, change requests, and project timelines to meet key compliance and customer deadlines; develop remediation plans when necessary. Required Qualifications Minimum of a Bachelor’s degree with a technical emphasis in an appropriate scientific or engineering field. Minimum of 5 years’ experience in the pharmaceutical or equivalent industry GMP field, including Technical, Regulatory, Quality, or Operations. Familiarity with clinical supply batch disposition (release), clinical supply operations, or regulatory filing activities. Prior experience authoring, reviewing, or approving investigations, deviation management support, and CAPAs. Background in quality control, quality assurance, auditing, or regulatory affairs. Attention to detail, flexibility, and awareness of production and quality control problems. Creativity and effectiveness in solving quality and supply‑chain challenges. In‑depth knowledge of cGMPs and regulatory requirements applicable to the pharmaceutical field. Experience utilizing AI tools for routine tasks and project work. Evidence of leadership skills and highly developed oral and written communication skills. Demonstrated teamwork, ownership, accountability, and ability to adapt and pilot new concepts. Experience in change management. Preferred Skills Ability to independently manage multiple priorities and projects. Lead and support cross‑functional and multi‑level teams, including senior management. Strong analytical and problem‑solving skills. Knowledge of Lean Six Sigma and project management. Competency in ERP/MES, document management systems, SAP, PowerPoint, Excel, and Word. Compensation & Benefits Salary Range: $106,200.00 – $167,200.00 annually. Eligible for an annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, and other health insurance for employee and family; retirement benefits, including a 401(k); paid holidays, vacation, and compassionate/sick days. Equal Employment Opportunity As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination based on race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit EEOC Know Your Rights. #J-18808-Ljbffr MSD Malaysia