QC Manager
At HALIX, we enable our customers to find cures for impactful diseases. To support our ambitions we are looking for a QC Manager.
As the QC Manager, you will lead the QC department and the QC teams. At HALIX the QC teams include Microbiology, Incoming Goods Inspection, QC Project Support and Analytics. The QC Manager provides hierarchical people management to the team and defines the organizational structure including for which positions to hire.
The QC Manager defines the QC strategy and tactical implementation of that strategy, the QC budget needs, as well as the continuous improvement projects for QC. He or she is a permanent member of the MT, defines the priorities for the department and is accountable for the QC Quality Management System.
Your tasks
- Accountable for the overall (biological) safety of the QC department and compliance with (biological) safety regulations and guidelines.
- Responsible for all hierarchical people management responsibilities of the QC department.
- Accountable for the overall GMP level of the QC department and compliance with all EU and FDA cGMP regulations and guidelines.
- Responsible for writing, reviewing and approving Quality related documentation such as but not limited to specifications, test methods, sampling instructions, CAPA’s, Changes, Deviations, Procedures, and Work Instructions.
- Responsible for the resourcing and the performance of the QC department to meet the project deliverables
- Accountable for implementation and execution of test methods in compliance with latest Ph. Eur, other applicable pharmacopeia and cGMP guidelines and regulations.
- Accountable for the technology transfer process of development test methods into qualified / validated test methods to support QC release testing of Drug Substance and Drug Product.
- Responsible for defining the QC strategy and tactical implementation, such as CAPEX to ensure capabilities meet customer requirements.
- Point of contact during (external) inspections and for audits of external contracted labs.
You have
- MSc Degree in Biology, Chemical or Pharmaceutical Science with 5 year work experience or Bsc degree with 7+ year work experience in a management position in microbiological, biochemical and analytical chemical assays.
- At least 3 years in depth experience with pharmaceutical QC management systems and contract manufacturing client projects.
- Strong understanding of FDA and EU QC xGMP regulations.
- Good command of the Dutch and English language, both verbally and in writing
- Excellent technical writing skills.
Who are we looking for?
To expand the QC organization within HALIX, we are looking for a result oriented candidate who is organizational savvy and has leadership and analytical skills.
Our 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 communication. The patient’s well-being is always our top priority. This combination is the basis for an interesting and challenging environment.
- You will be working in our dynamic headquarters in Leiden.
- Being part of a company that is focused on excellence in GMP Manufacturing.
- A competitive salary that matches your responsibilities and experience.
Your application
We look forward to hearing from you! We are interested in your CV, but we also want to find out more about your ambitions, your personality and what drives you to apply. So be sure to include a brief cover letter telling us why you are a match for this position. The application process consists of an introduction by the Recruiter, two interviews either via video call or live at our office in Leiden with the Hiring Manager and/or a Department Specialist followed by contract negotiations. Depending on the vacancy, an assessment could be part of the process.
Important notice to search firms and recruitment agencies
HALIX does not accept unsolicited approaches from recruitment agencies and/or search firms (such as, for instance, the sending of resumes) for any job posted on this or a referring website. All recruitment agencies and search firms are required to contact HALIX Recruitment via recruitment@hal-allergy.com to enquire about a potential recruitment or search agreement with HALIX.
HALIX, Bioscience as a Service
HALIX is a fast growing, biopharmaceutical contract development and manufacturing organization (CDMO) focused on viral vector and recombinant protein products. We support our customers with the development & commercialization of biologics enabling the treatment & prevention of life threatening conditions such as cancer, COVID-19, influenza and other infectious diseases. Our state of the art GMP manufacturing facilities and our experienced and dedicated team of people ensures manufacturing capabilities which meet the highest quality standards, a service oriented way of working and a flexible mindset. If you too would like to become part of an innovative and challenging contract development and manufacturing organization (CDMO), then this is a perfect opportunity!
HALIX is headquartered in Leiden, where all disciplines work under one roof, from development to sales. We work in an informal, culturally diverse organization with room for growth and continued personal development. HALIX is located in the middle of the thriving and energetic Leiden Bio Science Park, the largest innovation district of the Netherlands in the field of Life Sciences & Health. The central train station and the ancient city center of Leiden are just a 5 minute bike ride away from our office.
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