Job highlights

- 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
- Experience collaborating with CROs and third party vendors. .

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.

Skills & Competencies

- Demonstrated ability to manage complex, high pressure situations with a structured, organized approach.
- Solid 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.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

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