Croda Denmark (Biopharma Adjuvants): Built new QA/QC/RA organization in 8 months. Improved release lead times by 50%. Reduced scrap rate by 35%. Ensured §39 GMP license to operate & sterile API certificate. Led major tech transfer and compliance initiatives. Programme manager. Senior Leader of the Year 2024, Croda Inc.
Carmo A/S (Medical Devices): Led certification with Notified Body. Developed new Quality Strategy. Strengthened quality governance and cross-functional alignment. Programme manager.
Chr. Hansen (Novonesis): Ensured FSSC 22000 certification. Implemented new QMS across 4 sites. Led QA in acquisition of HSO Health Care GmbH.
ALK: Led 15 specialists across GMP documentation, batch review, deviations, CAPA. Standardized batch documentation and release processes. Strengthened production flow and visual management. Programme manager.
Bavarian Nordic: Led 18 specialists across GMP documentation, validation, tech transfer and QMS. Standardized batch review and improved release flow. Strengthened validation and tech transfer.
Novo Nordisk: (2002-2008): Manager QA Raw Materials. Responsible for quality of all incoming materials across multiple product lines. Built robust QA systems and supplier quality processes.
NNIT / Coloplast: QA Manager roles in quality & security (NNIT 2009-2010) and QA project manager (Coloplast 2008-2009). Delivered compliance improvements and cross-site QA governance.
Why Annette: 25+ years in pharma/biopharma QA/QC/RA production. Deep GMP, sterile API, and tech transfer expertise. Proven ability to build and lead high-performing QA and production teams. Strong track record in complex, high-stakes execution.
Regulatory track record: Experienced with global regulatory frameworks and inspections. GMP license to operate (§39), Sterile API Certification, FSSC 22000, Notified Body Certification for Medical Devices. ALCOA+ and data integrity compliance. Senior consultant.
Languages & Profile: Danish (native), English (fluent). ICF-certified COACH. Senior Leader of the Year 2024 (Croda). Decisive, structured, and highly execution-oriented leader. INSIGHT MOTIVATOR
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