QC Strategic Operation Lead

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.