Job Number: z5G7h3l6a1kMvyS65NP3c7FvqB-bDg7ga_53JjYtta0=
Pay Rate: N/A USD
Job Title: Validation Program Manager
Location: North Chicago, IL (Oniste)
Duration: Full Time
- Required experience as project & program manager, subject mater expert(SME) of QMS (quality management system) & CSV (computerized system validation/qualification), GxP compliance, QA/QM, etc.
- Understanding and good hands experience in managing End to end application/computerized system life cycle management
- Required Skilled & experienced in setting-up/continuous improvement of hybrid/harmonized (traditional + agile) QMS, CSV/GxP - framework for traditional & cloud/digital/AI-ML technologies according to global quality/GxP standards & regulations (i.e. US FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ISO, etc.).
- Good experience in document management, deviation management, change management, complaint management, CAPA management, etc.
- Well versed in project/program management(traditional, agile, hybrid) techniques and tools: MS project, project/program planning, monitoring, tracking, risk management, scope management, schedule control, cost control, budgeting, people management, executive communications, and expectation management.
- Client and vendor audits (internal & external), CAPA/deviation management, and regulatory inspections management
- High mentoring ability, a personality with strong decision making and analytical mindset with exceptional communication skills.
- Provides solutions to a wide range of difficult problems. Ensures that solutions are compliant, innovative, thorough, practical and consistent with organizational objectives. May lead projects with cross-functional or broader scope.
- Interacts effectively with employees, manager, and cross-functional peers. May represent own team while on cross-functional project teams with other functional leaders. Communicates confidently and effectively with management, peers, and key stakeholders.
- Implements tactical solutions related to assignment. Able to contribute functional skills and expertise broadly.
- Directly influences project direction and scope. Scope includes one or more QA functions, with general knowledge of other related disciplines.
- Provides guidance and trains other Professionals and Technicians. May provide oversight to one or more QA professionals and/or contractors.
- Quality System Compliance - Demonstrates good, general understanding of the standards and regulatory bodies that regulate our industry. Ensures compliance to site level policies and procedures and demonstrates a solid understanding of Division and Corporate policies and procedures by promptly addressing noncompliance issues within Division and Corporation as appropriate. Ensures adherence and maintains the effectiveness of the Quality System, including the Subsystems and Key processes that govern the area by promptly addressing non-compliance issues.
- Ensures evaluation of product safety and efficacy and elevation of risk-based issues and creates and reviews risk management documentation to reduce or eliminate risk
- Formulates thorough reason and justification for change. Identifies critical parameters associated with change.
- Applies solid understanding of quality system elements from product inception through launch.