Senior Manager - Development Quality Assurance

Career Opportunities: Senior Manager - Development Quality Assurance (59711) Requisition ID 59711 – Posted – ALL – India Sr. Manager – Development Quality Assurance Business Unit: Global Development Centre Job Grade: G9B/G9A Location: Princeton, NJ site and global facilities Job Purpose The Manager, Development Quality Assurance (Inspection Readiness) within the Global Development Organization (GDO) is responsible for establishing, maintaining, and advancing global regulatory inspection preparedness. This role ensures a sustained state of compliance with applicable Health Authority requirements (e.g., FDA, EMA, MHRA, PMDA) and supports successful inspections through proactive oversight, risk‑based strategies, and effective cross‑functional engagement. The Manager/Sr Manager will act as a strategic partner to Clinical Development and Operations, Quality, Regulatory Affairs, Pharmacovigilance, Biometrics, Data Management, and external partners to instill inspection preparedness into routine operations and foster a culture of inspection excellence. Key Responsibilities Design, implement, and maintain a global clinical inspection preparedness framework across GDO asset programs in collaboration with cross‑functional stakeholders. Partner with the VP and Head of Development QA to define inspection readiness KPIs and contribute to governance reporting, dashboards, and risk monitoring activities. Drive ongoing preparedness activities, including mock inspections, gap assessments, and targeted readiness health checks. Embed inspection preparedness throughout the clinical trial lifecycle, including start‑up, conduct, and close‑out phases. Serve as the primary inspection readiness lead for Health Authority inspections at the Princeton, NJ site and partnering closely with regional inspection teams at global facilities. Oversee inspection preparation, execution, and follow‑up activities, including document readiness, inspection logistics, and SME preparation and coaching. Lead inspection response activities, including daily debriefs, Health Authority interactions, post‑inspection commitments, and CAPA development and tracking. Identify systemic inspection risks and lead mitigation, remediation, and continuous improvement initiatives. Ensure timely and effective completion of inspection‑related CAPAs and audit actions, monitoring effectiveness and sustainability. Communicate inspection risk, compliance posture, and readiness status to key stakeholders and senior leaders. Facilitate cross‑functional forums, training sessions, and lessons‑learned workshops in partnership with project management colleagues. Contribute to inspection/audit oversight of CROs, vendors, and other external partners to ensure preparedness. Develop and deliver inspection preparedness training and coaching for internal teams, clinical sites, and designated SMEs. Support onboarding and ongoing inspection preparedness education for new programs and personnel. Education Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related discipline; Master’s degree preferred. Experience Significant experience in Clinical Quality, Clinical Operations, and/or Regulatory Compliance. Direct and recent experience supporting or leading global GxP regulatory inspections. Strong working knowledge of GxP regulations, ICH guidelines, and global inspection processes and CAPA. Experience collaborating with CROs and third‑party vendors. Demonstrated ability to manage complex, high‑pressure situations with a structured, organized approach. Strong written and verbal communication skills, including experience interacting directly with Health Authority inspectors. In‑depth understanding of R&D regulatory requirements and inspection expectations. Proven ability to influence without authority across functions, levels, and geographic regions. Strong problem‑solving, risk assessment, and analytical capabilities. Experience with digital inspection readiness tools and document management systems. Ability to operate effectively in a global, matrixed pharmaceutical organization. Job Requirements Tenure: 14+ years Benefits We provide robust benefits and opportunities to foster personal and professional growth. Join us where every day is an opportunity to grow, collaborate, and make a lasting impact. Disclaimer The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s). #J-18808-Ljbffr