This role is a key contributor to ensuring real-time inspection readiness for GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice) compliance. The position involves managing multiple projects simultaneously, aligning them with corporate objectives while adhering to regulatory requirements. This individual will leverage technical expertise and project management skills to drive inspection readiness initiatives, provide support during regulatory inspections, and collaborate with internal teams and external partners. Recognized as a subject matter expert in quality assurance and compliance, the role works closely with cross-functional teams, including manufacturing, technical operations, and supply chain, to maintain high standards of quality and compliance.

Key Responsibilities:

Real-Time Inspection Readiness

• Develop and manage GMP/GDP Inspection Readiness Plans and drive their ongoing maturity.
• Collaborate with external partners and internal teams to identify potential inspection risks and ensure readiness.
• Create and oversee project management plans with clear metrics and milestones.
• Build and maintain dashboards to track progress and highlight areas for improvement.
• Assist in developing and managing mitigation plans to address inspection risks.
• Create comprehensive evidence binders to support inspections.
• Support global expansion activities by integrating inspection readiness and regulatory intelligence.
• Conduct routine quality system checks to ensure compliance.
• Utilize project management tools to streamline processes and improve efficiency.
• Maintain key inspection documents, including opening presentations, Site Master Files, SME lists, and storyboards.
• Provide cross-functional guidance and support to ensure all teams are prepared for inspections.
• Contribute to forecasting and developing tools to enhance inspection readiness.

Small Molecule GMP/GDP Support

• Manage requests for GMP/GDP certificates related to vendors and manufacturing sites.

Process Improvement and Additional Responsibilities

• Identify areas for improvement and participate in process enhancement initiatives.
• Revise and author standard operating procedures to align with current best practices.
• Lead or assist with special projects, offering project management expertise as needed.
• Support activities that ensure continuous quality improvement across processes and systems.

Qualifications:

• Master’s degree with 3–4 years of relevant experience, or Bachelor’s degree in a scientific or allied health field with 5+ years of experience.
• Expertise in project management, including the use of project management tools and dashboards.
• Strong organizational skills with the ability to manage cross-functional collaboration effectively.
• Excellent communication skills to facilitate collaboration across diverse teams.
• Proven ability to work in fast-paced environments while driving results with a sense of urgency.
• Critical thinking and problem-solving skills to assess and address multifaceted challenges.
• Familiarity with root cause analysis and CAPA (Corrective and Preventive Action) methodologies.
• Knowledge of GMP/GDP regulations, risk management principles, and compliance best practices.
• A proactive approach to process improvement and continuous quality enhancement.

This role is ideal for a results-driven professional who thrives in dynamic environments, enjoys problem-solving, and is passionate about maintaining the highest standards of quality and compliance.