Specialist PDM Program Expert

Skills

About the Role

You will translate regulatory, business, and quality requirements into compliant processes, training materials, and qualification solutions. You will lead requirement-integration initiatives, manage change and risk activities, support inspections and CAPAs, drive project deliverables, and communicate progress, risks, and resolutions to stakeholders.

Requirements

• Bachelor’s degree in Science, Business, or a related field
• 1–3 years of experience in a medium-to-large matrix organization
• At least 1 year of experience in a pharmaceutical, medical device, healthcare, compliance, or related R&D environment
• At least 1 year of experience in process design, training design, qualification management, or a related field
• Knowledge of global pre-clinical and clinical compliance regulations and guidelines
• Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook
• Experience with project management tools
• Understanding of AI concepts, responsible AI practices, and prompting techniques

Responsibilities

• Lead Adopting Regulatory Requirements and Quality Framework Integration initiatives
• Assess, develop, implement, and integrate compliant end-to-end processes
• Develop and maintain training and qualification materials
• Compare, assess, and integrate requirements across the Quality Management System
• Participate in content management and qualification transformation initiatives
• Contribute to changes, CAPAs, inspections, investigations, and regulatory requests
• Drive project timelines, deliverables, process design, training strategies, implementation, and maintenance
• Manage change management, risk management, issue resolution, and process analysis activities
• Provide project updates on progress, risks, and resolutions
• Advance data-centric content and qualification management initiatives

Benefits

• Annual bonus or sales commissions, subject to performance and location
• Vacation days
• At least 12 weeks of parental leave
• Bereavement leave
• Caregiver leave
• Volunteer leave
• Well-being reimbursement
• Financial, physical, and mental health programs
• Service anniversary and recognition awards
• Insurance plans for eligible employees and dependents