Director, Site Head of Quality

Vor 2 Tagen

Berlin, Deutschland Klein Hersh International Vollzeit

Contact: Tom Hayes

Phone:
267.948.1440

**Position Overview**:
The Head of Quality will maintain, guide, and support 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.

**Key Responsibilities**:

- Management of the Quality Assurance and Quality Control areas at the site, in line with corporate strategy and within regulatory requirements.
- Part of the management team at the Berlin site.
- 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 & QC).
- Ensure that a team is in place to maintain complaint management focused on handling complaints, change controls, deviations and CAPA.
- Provides bi-annual reports to senior management (Quality Management Review, QMR).
- Releases of the annual Product Quality Review (PQR) for products packaged at Berlin.
- Coordinates hygiene and cleaning measures at the site.
- 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.
- Leads, conducts, and follows up on supplier audits for Berlin.
- 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 site.
- Leads benchmarking of processes and quality systems.
- Leads project management to ensure effective planning and timely execution of all processes.

**Professional Experience/Qualifications**:

- Must speak German and English
- Must be on site in Berlin (hybrid model could be discussed but suboptimal)

**Location(s)**:

- Greater Berlin, Germany

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