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In-vitro Diagnostics Quality Manager
Job Posted: 16 hours ago
Salary: £ 60,300 - 64,700 / Annum
Job Type: Permanent
Location: Germany
Expire in: a month
Job Description
Quality Management & Control Lead (m/f/d)
Ensuring Excellence in IVD Compliance & Process Innovation
Qualitas is partnered with a globally recognised life science group to find a Quality Management & Control Lead for their cutting-edge in-vitro diagnostics (IVD) division. Their portfolio spans biosafety, molecular diagnostics, and pharmaceuticals, driven by in-house R&D and strategic collaborations.
In this role, you’ll spearhead the Integrated Management System (IMS), ensuring compliance, optimizing quality processes, and leading a high-performing QC team—all within a dynamic, growth-focused environment.
Key Responsibilities:
IMS Leadership:
* Implement, maintain, and evolve the Quality, Environment & Occupational Safety Management System to meet legal, normative, and internal standards.
* Define and optimize QM/QC processes to enhance efficiency and product quality.
Compliance & Audits:
* Serve as the primary contact for internal/external audits, certification bodies, and regulatory authorities.
* Act as "Control Manager" per §5 TierImpfStV, with future responsibility as "Qualified Person."
Quality Control:
* Lead the QC team, overseeing inspections (raw materials, in-process, finished products) and ensuring adherence to industry/regulatory standards.
* Develop and deliver training programs to uphold IMS standards across teams.
Documentation & Process Excellence:
* Create, maintain, and refine quality documentation (SOPs, reports, certifications).
* Drive continuous improvement initiatives in collaboration with production/R&D.
Your Profile:
Education:
* Master’s/PhD in Veterinary/Human Medicine, Biology, Chemistry, Biotechnology, or Pharmacy.
Experience:
* 2+ years in veterinary/human microbiology/serology.
* 2+ years in IVD production/quality control (mandatory for § TierImpfStV compliance).
* Proven track record in quality/process management (e.g., ISO, GMP, audit coordination).
Technical Expertise:
* Molecular biology techniques (PCR, RT-PCR, nucleic acid extraction, sequencing).
* Analytical mindset with a focus on process optimization and risk management.
Leadership Traits:
* Hands-on mentor with the ability to develop teams and foster a quality-driven culture.
* Proactive, structured, and collaborative—bridging cross-functional teams.
Ability to commute/relocate:
Oldenburg: Reliably commute or willing to relocate with an employer-provided relocation package (Required)Before You Apply
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