Alvotech hf

Alvotech er fjölþjóðlegt hátæknifyrirtæki í fremstu röð, þar sem yfir 1000 starfsmenn af um 64 þjóðernum vinna að því að móta framtíðina á sviði líftæknilyfja og auka aðgengi sjúklinga um allan heim að hágæða lyfjum. Margir af færustu vísindamönnum landsins starfa hjá fyrirtækinu. Við leyfum fjölbreytileika, forvitni og frumkvæði starfsfólks að njóta sín. Við bjóðum aðlaðandi starfsumhverfi í stöðugri mótun og ögrandi verkefni. Alvotech tryggir að jafnrétti kynjanna til launa og frama nái til allra starfsmanna, hérlendis jafnt sem erlendis. Við viljum laða að okkur færasta fólkið á hverju sviði, án tillits til uppruna eða kyns. Með þessum hætti getum við best þjónað hagsmunum sjúklinga og samstarfsaðilum okkar. Vertu með okkur í að bæta lífsgæði fólks og auka aðgengi að hagkvæmum líftæknilyfjum.

About

Director of Engineering & CSV Compliance

Join Alvotech´s Quality department as the Director of Engineering & CSV Compliance! Lead our team in Reykjavik, Iceland, ensuring top-notch quality and compliance in GMP manufacturing. Drive innovation, strategic direction, and excellence in engineering and validation processes.

Develops operations within own area
Understands and directs Engineering & CSV department’s influence on the Quality and organizational budget
Interprets & adapts policy guidelines within area
May influence new organizational processes & standards
Sets tactical direction for the short-to-midterm and develops operations within own area
Provides strategic input to Quality Systems department goals & objectives
Scope of influence is primarily within the Reykjavik, Iceland manufacturing facility
Role may interface with both internal & external stakeholders
Extremely deep subject matter expertise
Recognized as a thought leader

Helstu verkefni og ábyrgð

Provide leadership expertise and technical oversight for the Engineering & CSV Compliance team
Contribute to a state of inspection readiness at Alvotech by ensuring execution of department activities and documentation comply with applicable company policies and regulatory requirements
Support and provide QA oversight (review and approval) of process, shipping, equipment, facilities, and utilities qualification, as well as software and computerized equipment validation
Support the review and approval of the design and implementation of the validation system at Alvotech
Support creation, review, and approval of the Validation Master plan
Review and approve Validation Project Plans, Validation Plans, IQ/OQ/PQ protocols and reports
Quality representative for reviewing and approving User Requirement Specifications (URS) and System Impact assessment (SIA)
Collaborating with various departments responsible for planning and overview of specific qualification and validation activities:Engineering for facilities, utilities, and equipment (process and laboratory)<br>Support investigation of protocol deviations and discrepancies during qualification/validation activities
Serve as an author/SME, reviewer, and QA approver of Standard Operating Procedures (SOP) and other QMS and facility documents
Proactively identify, assess, and incorporate industry best practice and new regulatory guidelines relevant to Engineering & CSV Compliance into Alvotech Quality System and SOPs
Leadership of the Engineering & CSV Compliance team, including providing direction on routine and project-driven work assignments, performance management (inclusive of entire employment lifecycle), talent development, and succession planning

Menntunar- og hæfniskröfur

Bachelor’s Degree within a relevant area
5+ years of experience supporting a GMP manufacturing facility in the pharmaceutical or medical device industry
5+ years of experience in a people leadership role
Good understanding of GAMP 5 guide
Knowledge of and experience with validation and qualification specifically as relates to GMP manufacturing facilities, utilities, and GMP manufacturing equipment

Advertisement published9. April 2025

Application deadline14. May 2025

Language skills