Manager Quality Control at HAL Allergy
To build, maintain and continuously improve processes at the QC department according to current GMP regulations. Managing and coaching of employees working at the department. In order to improve processes in the organisation, provide (un)solicited advice to specific stakeholders based upon analytical test results.
- Managing the QC department, approx. 17 employees, consisting of 2 teams, Biochemistry and Microbiology, an Incoming Goods Inspector and a Stability Coordinator. Provides team oversight and solves issues independently related to technical or personnel source.
- Motivation and coaching of employees, conduct performance reviews.
- Approve/reject raw materials, packaging materials, intermediate and end products.
- Approve specifications, sampling instructions, test methods and other QC procedures.
- Maintain compliance status of the department, consisting of training, procedures, handling changes and deviations.
- Responsible for planning of analyses within QC, in order to guarantee efficient and well-timed test executions.
- Oversees implementation and execution of Quality – Arbo and Environment safety regulations.
- Responsible for managing, execution and reporting of ongoing stability studies.
- Set up, execute and reporting of stability studies related to changes and regulatory demands, in collaboration with the Stability Coordinator.
- Responsible for execution and reporting of validation of assays. Advises with regard to improvement of assays and protocols for validation studies.
- Responsible for set up and maintenance of trend analyses.
- Advise management, project managers and QA director, based upon reports and test results.
- LIMS management, owner of the system, keeps system up to date and compliant.
- Responsible for total sampling process (traceability, number, documentation, warehousing)
- Set up of department goals and responsible for strong results.
- Continuously initiate improvements related to efficiency and quality.
- Budget responsible.
- Point of contact during (external) inspections and for external contracted labs.
- Master’s Degree in Biology, Chemical or Pharmaceutical Science.
- Extended experience with microbiological, biochemical and analytical chemical duties.
- 5-8 years relevant working experience in a similar management position.
- Strong GMP knowledge.
Personal & Professional Skills:
- Strong people management skills. Develops, coaches and corrects personnel where needed.
- Pro-active attitude and able to solve problems, also when this is not part of routine-work.
- Able to carry out several activities and projects in parallel.
- Strong ability to convince others, present ideas, points of view and plans in a natural way, taking others opinions and interests in to account.
- Analytical skills, able to set priorities and able to make fundamental decisions.
- Ability to work under time pressure.
HAL Allergy is a modern company with high quality pharmaceutical GMP manufacturing and research facilities located in the Leiden Bio Science Park. With offices in seven European countries, we are one of the top European players in the field of allergy diagnostic and treatment. Since 1959 we have gained experience in developing, producing and selling allergy therapies for the treatment and prevention of allergic diseases. These immunotherapies are used primarily against common allergies such as hay fever, house dust mite allergy and allergic reactions towards wasp or bee stings. Beside the development and production of allergy vaccines, HAL Allergy started a new business in 2012. This new Contract Manufacturing Organization (CMO), named HALIX, is engaged in the production of biotechnological products for preclinical and clinical studies. HAL Allergy Group is a mid sized company with headquarters in Leiden. We employ around 300 highly specialized people across various roles. The departments at our headquarters include development, production, quality assurance and control, clinical and registration. Our staff work closely together with leading research institutes. At our locations in Germany, Poland, Austria, Spain and Italy we mainly focus on service and sales activities.