Head of Quality Assurance Permanent

Head of Quality

Special Competences:

· 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.

Job Objectives:

· 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.

Specification:

· 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

· Persuasive

· Pragmatic, solution-oriented person with positive energy, tenacity and resilience