The Role
Lead and manage process development projects across cross-functional teams, ensuring cGMP and regulatory compliance. Develop business cases, identify and mitigate risks, apply lean Six Sigma and continuous improvement, allocate resources, document work per SOPs, and support non-standard shifts to meet timelines and quality goals.
Summary Generated by Built In
We are seeking a Process Development Principal Scientist to support all phases of inspection project management—from planning and implementation to monitoring, completion, and follow-up—ensuring alignment with goals, timelines, and quality standards.
Responsibilities:
- Lead PD related Project Management projects and activities, timelines and resources allocation.
- Work in teams with multiple fields, including manufacturing, process engineering, maintenance, quality assurance, and validation to implement projects.
- Support the development of comprehensive business cases including technical and financial requirements.
- Identify potential project risks, schedule changes, or resource constraints. Develop and implement solutions to maintain scientific efficiency, quality, and client satisfaction.
- Maintain strict adherence to domestic and international regulatory requirements, internal policies, and standard operating procedures throughout the project lifecycle.
- Balance competing timelines and priorities, ensuring critical tasks are completed efficiently and project standards for quality and quantity are met.
- Provide flexibility to support extended hours, non-standard shifts, and evolving project demands as needed.
- Ensure activities follow cGMP procedures and are documented according to cGMP requirements including assigned training.
- Independently evaluate, select and apply standard engineering techniques and procedures.
- Perform assignments that have clear and specific objectives and require investigation of a limited number of variables.
- Applies lean six sigma, operational excellence and continues improvement in assigned projects.
- Prompt and regular attendance to workplace. Although main working hours are regular 8:00 am to 5:00 pm the candidate need the flexibility to support non-standard shift operations in a 7/24 format including extended hours and/or weekends as needed.
- Meet specific project team goals and timelines.
- Develop project plans and strategies for implementation working with project managers and SMEs.
Requirements
Skills Required
- Doctorate (PhD) + 2 years scientific/engineering experience OR Masters + 5 years OR Bachelors + 7 years
- Bilingual English and Spanish, written and spoken
- Knowledge of and adherence to cGMP procedures and documentation requirements
- Experience applying Lean Six Sigma, operational excellence, or continuous improvement methodologies
- Project management experience leading timelines, resources, and cross-functional teams
- Experience with regulatory requirements, internal policies, and SOP compliance
- Ability to develop technical and financial business cases
- Willingness and ability to support extended hours, non-standard shifts, weekends as needed
- Ability to independently evaluate and apply standard engineering techniques and procedures
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
The Company
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
