Position Summary
We are seeking an experienced QA CMC professional to work closely with the Hemab CMC and Manufacturing Team to ensure compliance with applicable GMP regulations and guidelines (e.g., FDA, EMA, ICH) and ensure inspection readiness. You will serve as the primary quality interface with our contract development and manufacturing partners (CDMOs), ensuring GMP compliance throughout our outsourced operations.
As part of the Hemab Quality organization, you will ensure product quality and the reliability of clinical research and development data. You will champion our quality culture by promoting awareness through training and active participation in cross-functional teams and task forces.
This role demands attention to detail combined with the ability to drive results independently and collaboratively with stakeholders across the organization.
Key Responsibilities
- Ensure oversight of outsourced activities in collaboration with the CMC and Manufacturing team
- Advisor and support for Hemab internal CMC and Manufacturing team
- Ensure traceability and compliance of CMC documentation
- Maintenance of the supplier program in collaboration with stakeholders
- Support in qualification of new vendors and service providers
- Coordinate and conduct GMP audits of CDMOs, testing laboratories and suppliers
- Coordinate and conduct internal audits/self-inspections
- Perform internal training in e.g. GMP and internal procedures
- Creates, reviews and approves CDMO/supplier quality agreements
- Monitor performance through KPIs and quality metrics
- Oversee and manage internal and external deviations, CAPAs, and change controls
- Participates in QMS continuous improvement, eDMS and eQMS implementations, problem-solving and corrective actions
- Writes/reviews/approves SOPs/other documentation
- QA review and approval of master and executed batch records, protocols and reports, specifications etc.
- Support regulatory inspections and audit readiness activities
- Monitoring of evolving regulations and guidelines
Required Qualifications
Education & Experience:
- Minimum a bachelor’s degree in Life Sciences (Pharm., Chemistry, Engineering, Biotechnology or related field (advanced degree preferred))
- 10+ years of pharmaceutical/biotech QA experience with significant CMC focus
- Direct experience managing quality oversight of CDMOs in a clinical-stage environment
- Working knowledge of GMP regulations (21 CFR Parts 210/211, EU GMP, ICH guidelines)
Technical Expertise:
- Deep understanding of drug substance and injectable drug product manufacturing processes
- Experience with biologics development and manufacturing is a must
- Familiarity with analytical methods, specifications, and stability programs, and with clinical supply chain activities
- Knowledge of ICH Q7, Q8, Q9, Q10, and other relevant quality guidelines
Core Competencies:
- Strong technical writing and documentation review skills
- Excellent vendor management and relationship-building skills
Preferred Qualifications:
- Proven ability to conduct effective GMP audits is a plus but not a requirement
- Experience with multiple therapeutic modalities or manufacturing platforms
- Direct experience supporting regulatory inspections (FDA, EMA)
- Experience implementing quality systems in biotech environments
- Experience with application of Quality Risk Management
· Experience as QP/delegate QP is a plus but not a requirement
Position Details
- Location: Copenhagen
- Reports to: VP, Head of Quality
