QC Strategic Operation Lead
Alvotech · Reykjavík
Scope and Responsibilities:
- Management and oversight of individual analytical method transfers for QC, including protocol/report/gap analysis generation and implementation plans, review and approval workflows between the receiving and transferring unit.
- Participate in preparations for regulatory submissions, inspections, and responses to health authorities and/or partners for QC related activities.
- Responsible for ensuring timely completion of individual projects and assisting with establishing and maintaining departmental metrics.
- Independence in assignments and take part in small to medium departmental/cross-functional projects.
- Routinely leads projects internally and with external stakeholders
- Expert knowledge within the field of expertise such as analytical methods, techniques and equipment as well as relevant procedural/process knowledge.
- Ability to discuss challenges and communicate business critical information to supervisor or other relevant stakeholders.
Specifics of the role:
- Execution of day-to-day activities within the QC department relating to Analytical Method Transfer, Partner requests, CMO requests and Health authority related activities.
- Ensuring timely completion and support to Health Authority related activities, Partner requests and Analytical Method Transfers.
- Performs both routine tasks within procedures, processes and non-routine tasks such as identifying and/or support/lead change controls, document updates, and CAPAs.
- Management of individual Analytical Method Technology transfer/validation documentation.
- Identifying required document changes and updating of quality documentation.
- Provide technical training and support to the team as needed.
- Be aware of and comply with Alvotech’s current EHS policies.
Job requirements:
- Education: Minimum B.S in a technical discipline, (e.g., pharmacy, biotechnology, biochemistry, or a related field)
- Experience: 5+ years of experience in the pharmaceutical or biopharmaceutical industry.
- Experience in quality management system, analytical method transfers, and working cross functionally with excellent communicational skills.
- Good conceptual, problem-solving, and organizational skills – must be detail-oriented, well-organized, and able to work independently and in teams.
- Fluent command of the English language, both written and verbal.
What we offer:
- An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
- The chance to be a part of a global and fast-growing company.
- An international work culture that encourages diversity, collaboration and inclusion.
- Positive, flexible, and innovative work environment.
- Support for personal growth and internal career development.
- Company social events and milestone celebrations.
- Excellent in-house canteen and coffee house.
- Exercise and wellbeing support for full-time employees.
- On-site shower facility.
- Transportation grant towards eco-friendly modes of travel for full-time employees.
- Internet at home for full-time employees.