Quality Program Manager

Job Responsibilities

Program Management: Manages multi-site or medium/high complex programs over 2–3 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: Bachelor’s or Master’s degree in life sciences, business administration, or engineering.

Experience: 5–10 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