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Job Requirements of Senior Quality Program Manager:
-
Employment Type:
Contractor
-
Location:
Latham, NY (Onsite)
Do you meet the requirements for this job?
Senior Quality Program Manager
Careers Integrated Resources Inc
Latham, NY (Onsite)
Contractor
Project and Program Management
Senior Quality Program Manager
Job Responsibilities
Program Management: Manages multi-site or medium/high complex programs over 23 years or financial impact of ? 10M. Innovates and elevates program and portfolio capabilities.
Strategic Leadership: Provides strategy and direction for major functional areas through assessment of intangible variables and identification of fundamental issues.
Risk Management: Encourages balanced risk-taking and mitigates risks to maintain program health. Familiarity with risk management standards such as ISO 14971.
Quality Compliance: Utilizes quality principles (QMS, CAPA, Nonconformance, Calibration, PM, Process and Production Controls, Warehousing, etc.) within project management.
Stakeholder Engagement: Interacts internally and externally with senior-level management; negotiates extremely critical matters including influencing policymaking.
Methodology & Coaching: Expertise in applying PM standards (PMI, PMBoK, SAFe) and coaching others in project/program management processes.
Operational Execution: Uses detailed knowledge of company operations to promote innovative concepts and develop resolutions to critical issues. On-site presence required.
Minimum Requirements
Education: Bachelors or Masters degree in life sciences, business administration, or engineering.
Experience: 510 years of relevant working experience, including all aspects of project development and execution. 5+ years of program management experience with a demonstrated record of success.
Certification: Project Management Practitioner/Expert/Master or equivalent (PMI, PMBoK, SAFe).
Compliance Knowledge: Knowledge of ISO 13485 and FDA 21 CFR Part 820 for medical devices; comprehensive training in Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
Preferred Qualifications
Experience: Experience working in programs specifically supporting the program manager in program management activities.
Expertise: Known authority on process-oriented skills with consistent application.
Preferred Skills
Project/Program Management (PMI, PMBoK, SAFe)
Quality Management Systems (QMS)
CAPA Processes
ISO 13485 & FDA 21 CFR Part 820
ISO 14971 Risk Management
Strategic Planning & Policy Influencing
Negotiation & Senior Stakeholder Management
Innovative Problem Solving
Senior Quality Program Manager
Job Responsibilities
Program Management: Manages multi-site or medium/high complex programs over 23 years or financial impact of ? 10M. Innovates and elevates program and portfolio capabilities.
Strategic Leadership: Provides strategy and direction for major functional areas through assessment of intangible variables and identification of fundamental issues.
Risk Management: Encourages balanced risk-taking and mitigates risks to maintain program health. Familiarity with risk management standards such as ISO 14971.
Quality Compliance: Utilizes quality principles (QMS, CAPA, Nonconformance, Calibration, PM, Process and Production Controls, Warehousing, etc.) within project management.
Stakeholder Engagement: Interacts internally and externally with senior-level management; negotiates extremely critical matters including influencing policymaking.
Methodology & Coaching: Expertise in applying PM standards (PMI, PMBoK, SAFe) and coaching others in project/program management processes.
Operational Execution: Uses detailed knowledge of company operations to promote innovative concepts and develop resolutions to critical issues. On-site presence required.
Minimum Requirements
Education: Bachelors or Masters degree in life sciences, business administration, or engineering.
Experience: 510 years of relevant working experience, including all aspects of project development and execution. 5+ years of program management experience with a demonstrated record of success.
Certification: Project Management Practitioner/Expert/Master or equivalent (PMI, PMBoK, SAFe).
Compliance Knowledge: Knowledge of ISO 13485 and FDA 21 CFR Part 820 for medical devices; comprehensive training in Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
Preferred Qualifications
Experience: Experience working in programs specifically supporting the program manager in program management activities.
Expertise: Known authority on process-oriented skills with consistent application.
Preferred Skills
Project/Program Management (PMI, PMBoK, SAFe)
Quality Management Systems (QMS)
CAPA Processes
ISO 13485 & FDA 21 CFR Part 820
ISO 14971 Risk Management
Strategic Planning & Policy Influencing
Negotiation & Senior Stakeholder Management
Innovative Problem Solving
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