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.

Vinnustaðurinn

Quality Management Systems (QMS) - Senior Manager

Join Alvotech as a Qualtiy Management System (QMS) Sr. Manager! You'll lead quality management system activities, ensure compliance with regulatory standards, participate in the audits, and drive continuous improvement initiatives. Ideal candidates have strong expertise in QMS, excellent analytical skills, and a proactive approach to problem-solving.

Helstu verkefni og ábyrgð

Responsible for ensuring compliance with all applicable provisions of the Quality Management System and the regulations and standards applicable to their operation.
Acts like process owner of Quality Systems implemented, such as Complaints, Deviations, CAPAs, Change Controls, PQR or other. Manages and coordinates processes.
Responsible for the coordination of management escalation procedures.
Ensures compliance with effective implementation of SOPs and cGMPs
Proposes and executes programs for measuring compliance and quality through pertinent metrics on key performance indicators and provides periodic reports at Operational and Management Review meetings as scheduled.
Communicates identified compliance and quality risks to Director QMS and/or above and recommends solutions for improvement; performs follow-through on implementation of appropriate changes to systems and/or processes.
Ensures Team members and employees involved in quality management system processes receive appropriate guidance to facilitate the implementation of quality system requirements.
Assists in establishing department goals in alignment with the site strategy and acts as needed to ensure timely delivery of goals.
Proposes and communicates metrics designed to measure the success of QMS activities.
Oversees, manages, coordinates, and prioritizes the daily activities of the QMS to ensure that all related functions are effectively deployed.

Menntunar- og hæfniskröfur

University Degree (BS/MS) in relevant Science or Engineering discipline (Biology, Biochemistry, Chemistry, Chemical Engineering, Microbiology or similar).
Minimum 6+ years of experience in managing Quality Assurance and/or Quality Systems functions.
Expertise in GMP compliance, Health Canada, FDA and/or EMA regulations.
Experience with implementing and overseeing GMP operations in a plant manufacturing of commercial products is required, with PD and clinical material manufacturing as highly desired.
Background in Protein Biologics or Monoclonal Antibody is highly desired.
Demonstrated experience building and leading exceptional teams is required.
Demonstrated excellence in written and verbal communication.
Demonstrated ability to work cross-functionally and to develop and maintain strong partner relationships

Fríðindi í starfi

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.