The Head of Commissioning and Qualification is responsible for leading the strategy, planning, and execution of commissioning, qualification, and validation activities across projects and operational facilities. This role ensures that equipment, systems, and processes are installed, tested, and verified in compliance with regulatory requirements, quality standards, and project timelines. By collaborating closely with engineering, manufacturing, quality, and project teams, the Head of Commissioning and Qualification drives operational readiness and supports the successful delivery of facilities and products.
Key responsibilities and minimum requirements according to job level:
Strategic Leadership
- Develop and implement the site-wide C&Q strategy aligned with business objectives and regulatoryrequirements.
- Establish and maintain a risk-based commissioning and qualification framework across all engineeringand manufacturing systems.
- Provide technical leadership for qualification activities associated with facility expansions, capitalprojects, and technology transfers.
- Act as the site Subject Matter Expert (SME) for Commissioning and Qualification (C&Q).
- Ensure all C&Q activities support operational excellence, product supply reliability, and compliance objectives.
Commissioning & Qualification Program Management
- Oversee commissioning and qualification of:
- Manufacturing equipment
- Single-use bioreactor systems
- Perfusion and upstream processing systems
- Downstream processing equipment
- Fill-finish systems
- Clean Utilities
- HVAC systems
- Cleanrooms and environmental control systems
- Process automation and computerized systems
- Laboratory equipment and supporting infrastructure
Ensure successful execution of:
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Support the successful execution of process Validation activities
Review and approve qualification protocols, reports, and validation lifecycle documentation.
Ensure all qualification deliverables are completed according to project schedules and approved budgets.
Project Deliver
- Lead C&Q activities for large-scale capital projects and facility expansions.
- Collaborate with Engineering, Manufacturing, MSAT, Quality Assurance, Automation, and Regulatory Affairs teams.
- Ensure qualification activities are integrated into project execution plans from design through handover.
- Manage external engineering firms, EPCM contractors, C&Q, and equipment vendors.
- Provide governance and status reporting for senior leadership.
Compliance & Quality
- Ensure compliance with: o EU GMP Annex 15
- EudraLex Volume 4
- FDA 21 CFR Parts 210, 211, and 11
- ISPE Baseline Guides o ASTM E2500 principles
- GAMP 5 requirements
- Support regulatory inspections and customer audits.
- Lead investigations related to qualification deviations and commissioning issues.
- Review and approve technical assessments, change controls, CAPAs, and risk assessments.
- Maintain a state of continuous inspection readiness.
Operational Support
- Establish lifecycle management programs for qualified systems.
- Ensure periodic review and requalification activities are risk-based and effective.
- Support troubleshooting and complex engineering investigations related to GMP systems.
- Drive improvements in qualification efficiency and documentation quality. · Develop qualification metrics and performance indicators.
People Leadership
- Build, lead, mentor, and develop a high-performing C&Q team.
- Define resource requirements and competency development plans.
- Promote a culture of safety, compliance, accountability, and continuous improvement. ·
- Support succession planning and talent development within the engineering organization.
Competencies required to fulfill the employee responsibilities and work assignments:
- An employee shall follow the job description that pertains to the position. In addition, an employee shall follow the SOPs that pertain to the position.
- An employee shall adhere to the company policies and procedures that are available on the Alvotech intranet – Alvocado.
Additional competencies required to fulfill key management responsibilities:
Leadership
- Decision-making under pressure
Technical
- C&Q Program Leadership
- GMP Compliance
- Risk Management
- Project Execution
- Regulatory Inspection Readiness
Business
- Financial management
- Resource planning
- Contractor management
- Continuous improvement
Key Performance Indicators (KPIs)
- On-time completion of qualification projects.
- Schedule adherence for capital project milestones.
- Successful regulatory inspections with no critical observations related to qualification activities.
- Reduction in commissioning and qualification cycle times.
- Closure of qualification deviations within target timelines.
- Budget adherence for C&Q programs.
- Equipment readiness to support manufacturing schedules.
- Team engagement and development metrics
Education and experience required for the role:
Education:
- A university degree in engineering or natural sciences, or relevant business experience
- Ongoing relevant courses and training activities.
Experience:
- 10+ years of experience in the pharmaceutical industry.
- Proven ability to lead and manage people and their activities.
- Expertise in qualification of equipment for aseptic and biological processes.
Additional Skills:
- Very good communication skills, both written and oral.
- Strong interpersonal skills.
- Strong analytical skills to facilitate and advise on complex and multidisciplinary areas
- Ability to handle multiple concurrent tasks.
- Good assertive skills.