Biogen — ауыр неврологиялық ауруларға арналған емдеу әдістерін зерттеуге, әзірлеуге және ұсынуға бағытталған биотехнологиялық және денсаулық сақтау компаниясы. Компанияның қызметі Альцгеймер ауруы, склероз және жұлын-бұлшықет атрофиясы сияқты ауруларды қамтиды; неврологияны дамыту үшін клиникалық зерттеулерді, ғылыми ынтымақтастықты және дәрі-дәрмек әзірлеуді біріктіреді. Компания сондай-ақ медициналық көмекке қолжетімділікті жақсартуға және денсаулық сақтау саласындағы теңдікті арттыруға мән береді.
Principal Quality Auditor, GMP and ISO 13485
Lead complex GMP, ISO 13485, and global GxP audits for Biogen, a biotechnology company developing medicines. Oversee supplier audits, corrective actions, and inspection readiness.
Сипаттама
- Lead complex, high-risk internal GMP/GDP and ISO 13485 audits independently across Europe and other regions.
- Conduct for-cause audits of critical suppliers, contract manufacturers, and service providers.
- Use risk-based audit methods that account for regional regulatory requirements.
- Produce audit reports ready for regulatory inspection.
- Assess and approve CAPA responses to complex findings, and track remediation.
- Provide senior technical guidance and coach auditors during complex audits.
- Assist the Associate Director with the regional audit program, including coordinating schedules.
- Advise on regulatory engagements and inspection preparation.
- Mentor auditors and build the broader audit team's capabilities.
- Present critical findings and compliance gaps with appropriate senior-level context.
- Shape remediation plans and track resolution of significant quality issues.
Талаптар
- Bachelor of Science in life sciences, engineering, or a related technical field.
- At least 13 years of experience in a regulated pharmaceutical, biotechnology, or medical device environment for Principal level.
- At least 5 years of progressive audit experience, including leading complex, multi-country audits, for Principal level.
- Expertise in EMA expectations, ISO 13485, and global GxP frameworks.
- Fluent English for Principal level.
- Bachelor of Science in life sciences, engineering, or a related technical field for Senior Associate III level.
- At least 10 years of experience in a regulated pharmaceutical, biotechnology, or medical device environment for Senior Associate III level.
- At least 4 years of audit experience, including independent Lead Auditor responsibilities, for Senior Associate III level.
- Experience with ISO 13485 and global GxP regulatory frameworks, including FDA and EMA, for Senior Associate III level.
- English proficiency for Senior Associate III level.
- An advanced terminal degree such as an MD, PhD, or PharmD is preferred.
- Experience coaching and mentoring auditors is preferred.
- Additional language fluency is preferred.
- Experience with supplier qualification processes is preferred.
Артықшылықтар
- Stability and resources offered by an established biotechnology company.
- Opportunities to learn, grow, and broaden your skills.
- An inclusive workplace culture focused on belonging.