Head of Quality
· Management of the Quality Assurance, Quality Systems, Qualified Persons, and Quality Control areas at the site, in line with corporate strategy and within regulatory requirements.
· Part of the Senior Leadership Team at the Berlin site.
· Leads and develops a strong quality culture, empowering the team, leading by example and placing responsibility at the right level within the organisation.
· Manages and motivates a high performing team.
· Determines and drives site Quality Metrics in line with Corporate and Site goals.
· Ensures that products are packaged and controlled to meet required safety, quality and GMP standards.
· Ensures that a system is in place for the following:
· All components for production are issued to production on time and in the prescribed manner.
· Reviews completed documentation.
· Tracks and monitors documentation throughput times.
· Quality Key Performance Indicators (KPIs) are established, measured, and maintained and are in line with company objectives.
· Acts as the main point of contact for quality related matters at the Berlin site.
· Acts as main contact person customers and auditors (e.g., of the responsible health authority).
· Leads the Quality department of Berlin (QA, QP & QC).
Description of tasks:
· Ensures that a team is in place to maintain complaint management focused on handling complaints, change controls, deviations and CAPA.
· Maintains, guides, and supports the various elements of quality management including audits, training, SOPs, documentation, change controls, complaints, investigations and CAPAs to ensure ongoing compliance with customer, regulatory and internal requirements.
· Provides bi-annual reports to senior management (Quality Management Review, QMR).
· Develops and monitors the annual budget for the quality department.
· Ensures all process documentation is fully auditable, i.e., created, updated, and filed in accordance with all regulatory expectations.
· Ensures a system is in place for a robust audit management system for both internal and external audits.
· Develops and maintains a culture of continuous improvement by actively implementing process excellence and lean methodologies.
· Actively promotes best practices for quality management improvement and continuous improvement and problem solving at the
· Leads benchmarking of processes and quality systems.
· Leads project management to ensure effective planning and timely execution of all processes.
· Any other duties assigned by supervisor.
· Business or science degree or equivalent qualification.
· Several years of experience in a similar role with demonstrable experience, preferably as a manager
· Knowledge of GMP and GDP regulations.
· Experience in operating ERP systems, ideally JDE (Oracle).
· High level knowledge of packaging equipment, facilities, and processes.
· To have good knowledge of Quality Assurance inspection requirements.
· Good working knowledge of cGMP
· QMS Experience
· Risk Analysis and Associated Methodology
· Knowledge of ICH, GAMPs, Annex 11 and Eurdalex guidelines
· Fluent in business German and English
· Very good Interpersonal skills
· Good written communication skills
· Technical aptitude
· Embracing company vision and values
· Analytical approach / attention to detail
· Excellent organisational, planning and management skills
· Excellent team player with strong leadership skills. Ability to build working relationships with stakeholders
· High flexibility to adapt, react quickly and deal with change in a fast-paced environment
· Self-motivated and organised
· Pragmatic, solution-oriented person with positive energy, tenacity and resilience