Manager QA Projects Amsterdam • Prothya Biosolutions

Accountabilities:

Strategic Quality Management: 

• Develops and implements quality assurance strategies and policies within QA projects.
• Ensures alignment of QA projects with corporate strategy and regulatory requirements.
• Manages the budget for QA projects and monitors cost control.

Change Control & Validation:

• Oversees change control processes and reviews and approves change control documentation and validation records.
• Asssures validation requirements and strategies for cGMP documentation are met.
• Coordinates the execution of change control procedures.
• Chair of the Change control board

Compliance and Quality Assurance:

• Ensures QA projects comply with GMP, GDP, and other relevant regulations.
• Acts as a subject matter expert within change control projects, providing compliance guidance.

Stakeholder and Relationship Management:

• Maintains close collaboration with departments such as Production, QC, and Regulatory Affairs.
• Represents QA in management and strategic meetings.
• Supports external audits and maintains relationships with regulatory authorities.

Reporting and Documentation:

• Ensures clear and complete documentation of QA projects, CAPAs, and validation dossiers.
• Analyzes and reports trends and risks to senior management.

Leadership:

• Translates annual departmental business objectives to the team and makes sure the objectives are met. Organizes the activities and tasks of the team.
• Lead the QA Project Team. Hire, coach and appraise employees, and develop employees using the relevant HR instruments, service and procedures.
• Ensures a safe, secure, and healthy work environment.
• Ensures collaboration within the team and other departments

Your profile:

• University level, knowledge on biology, chemistry or biochemistry. Preferably graduated in life sciences, Chemistry, Pharmacy or comparable.
• > 5 years of experience in Pharma.
• Experience in either pharmaceutical production or quality management
• Experience in biotech or sterile manufacturing is preferred
• Leadership experience, ideally experience with leading leaders
• Continuous improvement (CI) experience is preferred (e.g. green belt or black belt or comparable experience)
• Able to be pragmatic when possible and strict when needed
• Strong analytical and problem-solving skills, with the ability to make informed decisions based on data and risk assessment.
• Excellent interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams and communicate complex quality concepts to stakeholders at all levels.
• Strong leadership and team management abilities, with a focus on mentorship, development, and fostering a culture of quality and compliance.
• Detail-oriented mindset and ability to work in a fast-paced, highly regulated environment.
• Hands-on

Acquisitie wordt niet op prijs gesteld. Prothya aanvaardt geen ongevraagde hulp van bureaus voor deze vacature. Toegestuurde cv's (in welke vorm dan ook) door bemiddelingsbureaus aan enige medewerker van Prothya zonder geldige schriftelijke zoekopdracht, worden gezien als eigendom van Prothya waarvoor op geen enkele wijze een vergoeding verschuldigd is.