Head of Quality

Job content

My client is a rapidly growing, first-mover Swiss cannabis research and production company. They produce medical cannabis of the highest quality in a high-tech indoor cannabis production facility, which is distributed worldwide.

They are on the search for an experienced Head of Quality to oversee all quality assurance (QA) and quality control (QC) activities and ensure overall adherence to all GxP regulatory requirements.

This role will manage both the QA and QC teams, support budget management & resource planning, and report directly to senior leadership.

Previous experience leading a team and managing a quality control lab in a GMP manufacturing facility is required.

The role will be required to be onsite at the facility full-time. Relocation will be provided for the right candidate.

(Note: If EU Citizen: Must have Swiss Work Permit secured before signing employment contract).

Role and Responsibilities

Quality Control (QC)

• Implement and lead QC for the facility.
• Manage QC projects from a strategic point of view.
• Drive continuous improvement in the lab.
• Manage deviations and investigations.
• Enforce all safety and security policies and practices.
• Monitor the testing techniques and the accuracy and completeness of all records and documentation.
• Ensure that all in-process samples, raw materials and final products are analyzed in accordance with SOPs and regulatory requirements to applicable GMP’s/GxP’s and standards.
• Enforce all laboratory policies and practices.
• Ensure the calibration and maintenance of the lab instruments.
• Initiate and support Corrective and Preventive actions in the laboratory.
• Ensure audit readiness in laboratory, subject preparation and presentation during audit.
• Ensure the training of the lab analysts.
• Supervise and participate in the validation activities of the laboratory.

Quality Assurance (QA)

• Implement and lead QA for the facility.
• Contribute to a risk-based strategy for QA activities.
• Provide QA oversight within the company and at vendor sites.
• Review and approval of GMP relevant Documents like Plans, Reports, SOPs,
• Change Control, Discrepancy Management, CAPA (corrective action and preventive action), Risk Analysis.
• Provide advice and support for the audit process to ensure good audit practice.
• Prepare and host regulatory inspections and partner GxP audits.
• Plan and implement supplier and internal audits.
• Coordinate and lead internal or external training activities.
• Participate or lead departmental and cross-functional compliance initiatives.
• Management of the Quality Assurance and Quality Control teams.
• Monitor CAPAs.
• Creation and periodic review of quality agreements (QAGs) with contract organizations.
• Act as local expert for GxP related questions.
• Implement and update Technical Quality Agreements with Suppliers and Customers.
• Conducting effective Quality Review Meetings.
• Assistance is required in the introduction and training of new employees.

Qualifications

• Graduate degree in chemistry, biology, or a related field.
• Experience in laboratory management (preferred)
• Formal training in quality assurance and GMP guidelines (preferred)
• Minimum 5 years of experience in a quality assurance or quality control management position.
• Experience in auditing and dealing with the authorities.
• Statistical experience, as well as experience in data integrity.
• In-depth knowledge of GxP.
• Demonstrated people management and leadership skills.
• Fluency in German and English