Manager Qc

5 maanden geleden

Leiden, Nederland HAL Allergie GmbH Voltijd

HAL Allergy is one of the European top players in the field of allergy immunotherapy and has an internationally leading role in the production of modified allergen extracts for both, therapeutic and diagnostic purposes. To support us in our steady growth, we are welcoming a **Manager QC**.

As **Manager QC**, your role involves establishing, maintaining, and enhancing processes within the QC department in compliance with current GMP regulations. Collaboration with various departments like Analytical Development, QA, Production, Tech Services, RA, QP’s, and Tech Transfer is essential to ensure prompt testing of incoming goods, intermediates, and finished products in alignment with cGMP standards and approved specifications. Additionally, you are responsible for overseeing environmental and utility monitoring in adherence to cGMP principles.

Your challenge includes representing and communicating quality policies and performance to regulatory bodies, customers, and business partners, ensuring alignment throughout the company. Daily operations oversight is part of your responsibilities, fostering an environment where quality, safety, and continuous improvement are prioritized.

The Quality Control department comprises four teams - Biochemistry, Microbiology, Sample Management, and Support - supervised by 2 team leaders who report to the Manager QC. The QC department is undergoing a change in organizational structure in which all teams will be led by a Supervisor (4).

Your tasks
- Accountable for the results of the QC department. Manages the department, coordinating daily activities, setting priorities and ensuring effective daily operations, to ensure timely reporting of analyses, timely completion of quality records, and timely execution and reporting of stability studies.
- Accountable for personnel management within QC, including ensuring sufficient qualified personnel for the activities to be performed, the setting of performance objectives, employee performance evaluations, recruitment, disciplinary actions and other personnel actions.
- Ensure high-quality work is performed by the QC department and make sure that processes are compliant with the company
- and department SOPs as well as with applicable laws and regulatory guidelines.
- Coordinate and oversee the set-up and execution of relevant training, (implementation of) procedures, deviation
- and trend analyses, and the implementation of changes.
- Ensure the safety of assigned areas and work practices in accordance with plant and company ESH programs.
- Oversee and coordinate the preparation of specifications, sampling instructions, test methods and other required QC related procedures in collaboration with Analytical Development.
- Responsible for the Laboratory Information Management System (LIMS) and keeping the system up to date and compliant with relevant regulatory laws and regulations.
- Accountable for business continuity as owner of the test methods, equipment and systems used.
- Ensuring all methods, equipment and systems used are in a validated state and that business continuity is guaranteed (e.g. by means of back-up systems or outsourcing options).
- Accountable for all QC activities that are outsourced to external contract labs.
- Drive continuous improvement through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability, with the aim of reducing the number of deviations, incidents and near-misses, increasing right-first-time performance, and shortening leadtimes.
- Ensuring permanent inspection readiness within the QC labs, carrying out self-inspections for both quality and safety, and providing timely follow-up to audit observations.
- Identify all required QC expenditures and ensure that QC assays & -projects are executed within time and budget.

You have
- Master’s Degree in Biochemistry, Biotechnology, Molecular Biology, or similar
- Extended experience with and deep knowledge of microbiological-, biochemical
- and analytical chemistry assays and technologies.
- 5-8 years relevant working experience in a similar management position.
- Solid understanding and knowledge of applicable regulatory requirements and GMP quality directives is critical.
- Audit/inspection experience.
- Good command of the Dutch and English language, both verbally and in writing.

Who are we looking for?

Our new **Manager QC** is a critical thinker with a focus on results. Equally important he/she is able to manage talent effectively, has as collaborative mindset and understands organizational dynamics. The combination of ensuring that HAL Allergy's products meet high-quality standards and empowering your team members in the QC department is key in this challenging position.

**Offer**:

- You will be part of a steadily growing and dynamic biopharmaceutical company offering a great environment for self-starters.
- A culture that is characterized by entrepreneurial spirit and close and transparent co

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