This Job Listing is about Alvotech in Reykjavík, Capital Region, Iceland 2022
Overview Of Role
The Quality Compliance Manager fulfills a fundamental role in supporting and contributing to the execution of the quality compliance strategy for Alvotech. The candidate will lead critical compliance activities and will collaborate with multiple departments across all functions of the organization to provide compliance support. The candidate will be responsible for supporting compliance activities involving health authorities and audits. The candidate will lead gap assessments, commitments and ensure any quality risks identified are proactively mitigated. In addition, the candidate will provide health authority insight and direction to the company. The candidate must have excellent written and effective communication skills; and be flexible to work in a fast-paced environment.
The position requires a solid understanding of biologics (process/products), quality systems and health authority regulations as they relate to the manufacturing, testing and stability studies.
Scope and responsibility:
- Collaborates with other relevant line functions and prepareseviews health authority related documents
- Monitors compliance related processes to examine the overall quality system health
- Ensure site’s inspection readiness and prepares the site for health authority inspections, provide front room and back-room support
- Performs other Quality Compliance projects as required by management.
- Education: University degree in a relevant scientific discipline.
- Strong written and oral communication with colleagues and health authorities
- Strong problem-solving skills
- Experience in a Quality Compliance (e.g., Health Authority inspection management, inspection readiness, Quality System, etc.)
- Prior experience interacting with FDA or other regulatory agencies. Strong knowledge of multi-country cGMP regulations (U.S, EMA, PMDA, etc)
Alvotech is a biotech company, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities.
At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.
True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.
Vacancy Type: Full Time
Job Location: Reykjavík, Capital Region, Iceland
Application Deadline: N/A