20 часов назад
Head of QA Bioatrium (GMP Biopharmaceutical Quality)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Head of QA Bioatrium (GMP Biopharmaceutical Quality): Leading quality strategy, GMP quality operations, and regulatory readiness for a biopharmaceutical manufacturing site with an accent on quality systems, drug substance compliance, and inspection management. Focus on maintaining facility and process qualification, overseeing CAPA and outsourced services, and collaborating with Swissmedic, foreign health authorities, customers, and stakeholders.
Location: Visp, Switzerland
Company
is a global life sciences company developing products and services for pharmaceutical, vaccine, and biopharmaceutical applications.
What you will do
- Define and execute the BioAtrium quality vision, strategy, and milestone plans.
- Lead the quality organization, drive high quality standards, and foster continuous improvement and talent development.
- Maintain a compliant quality management system, including KPI monitoring, qualification oversight, GMP trend management, outsourced services, and complaints.
- Manage collaboration with Swissmedic, foreign health authorities, and customers to maintain the BioAtrium manufacturing license and inspection readiness.
- Coordinate inspection preparation, front and back offices, responses to observations, and CAPA follow-up.
Requirements
- Master’s degree in life sciences or related education.
- Several years of experience leading GMP biopharmaceutical quality operations and multidisciplinary teams in pharma, vaccines, or biopharmaceuticals.
- Demonstrated leadership of site management teams and experience starting up manufacturing facilities or businesses.
- Expertise in Drug Substance quality under ICH Q7 and GMP manufacturing of biopharmaceutical drug substances.
- Knowledge of therapeutic protein process development and technology transfer, plus operational excellence training in a GMP environment.
- English and German are essential; French is an advantage.
Culture & Benefits
- Work in a global life sciences environment focused on improving patient outcomes.
- Own career development while contributing ideas to complex scientific and operational challenges.
- Operate in an environment emphasizing ethical conduct, quality, compliance, and environmental responsibility.
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