Specialist PDM Program Expert
Global healthcare company operating Innovative Medicine and MedTech businesses, including a robotic-assisted bronchoscopy platform.
About Johnson & Johnson
Johnson & Johnson develops medicines, therapies, medical devices and health technologies across oncology, immunology, neuroscience, cardiopulmonary, cardiovascular, orthopaedics, surgery and vision.
Skills
Candidate Availability
Required and preferred rules are kept separate and reflect the wording in the original posting.
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, assess and improve processes, manage changes and risks, support inspections and CAPAs, track project delivery, and communicate progress across quality and R&D functions.
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.
- Awareness of life sciences regulatory and legal requirements.
- Microsoft Office proficiency, including Word, Excel, PowerPoint, and Outlook.
- Experience with project management tools.
- Understanding of AI concepts, responsible and ethical 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 GxP training and qualification materials.
- Compare, assess, and integrate requirements across the Quality Management System.
- Participate in content-management and qualification-transformation initiatives.
- Align business requirements, regulatory expectations, and Quality Management System processes.
- 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.
