About the Company
Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.
Position: Senior Program Manager
Location: Indiana
Duration: Long Term
Job Overview
We are seeking an experienced Senior Program Manager to simplify product development processes in a regulated medical device environment. The role involves improving R&D and Quality Management System (QMS) processes, reducing delays and rework, aligning teams, and implementing AI and automation solutions while maintaining quality and regulatory compliance.
Key Responsibilities
- Map product development, R&D, and QMS processes to identify inefficiencies, delays, and rework.
- Develop and implement a process improvement roadmap with measurable goals.
- Simplify workflows, eliminate duplicate documentation, and clarify roles and responsibilities.
- Collaborate with R&D, Quality, and Regulatory teams to ensure compliance with quality systems and regulatory requirements.
- Identify and implement AI and automation solutions for document preparation, review, data analysis, traceability, and information retrieval.
- Establish appropriate AI governance, human review, documentation, and controls.
- Lead process improvement pilots and measure cycle time, effort reduction, rework, adoption, and compliance.
- Develop and update SOPs, procedures, job aids, and training materials.
- Track performance metrics and communicate progress, risks, and recommendations to leadership.
- Lead cross-functional change initiatives, resolve competing priorities, and ensure sustainable process improvements.
- Transfer improved processes to process owners and establish plans for ongoing maintenance.
Required Qualifications
- Bachelor's degree in Engineering, Science, Quality, Operations, Business, or a related field; an advanced degree is preferred.
- 15+ years of experience in product development, quality systems, operational excellence, process engineering, or program management.
- Significant experience in the medical device or other regulated products industry.
- Strong knowledge of design controls, change control, Design History Files (DHF), and Quality Management Systems (QMS).
- Experience leading cross-functional process improvement and transformation initiatives.
- Knowledge of Lean, Six Sigma, value-stream mapping, or similar process improvement methodologies.
- Practical experience with AI and automation in business or technical workflows, preferably in regulated environments.
- Working knowledge of FDA Quality System requirements and ISO 13485.
- Experience with validated systems, regulated digital tools, data governance, or AI governance is preferred.
- Strong skills in stakeholder management, change leadership, facilitation, communication, and performance analysis.
- Ability to influence senior leaders and technical teams, manage competing priorities, and deliver measurable results independently.
- Lean Six Sigma certification is preferred.
How to Apply
Apply Now: Submit your updated resume to Stark Pharma Solutions Inc. for consideration.
Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.