QA Manager
Anocca AB · Södertälje · Tills vidare · Deadline 2026-12-31
Anocca AB is hiring a **full-time QA Manager** to join its GMP Operations team, which comprises approximately 30 colleagues across production, QC, QA, validation, facility, and project management. The position is responsible for the quality assurance of all operational activities supporting ATMP products for clinical trials. Core duties include approving documents, conducting deviation investigations, managing change controls and CAPAs, handling material release, training personnel, validating equipment, maintaining the Quality Management System (QMS), and validating release methods. Document administration forms a significant component of the daily work, and the role offers flexible working hours. Applicants must hold a **BSc or MSc in life sciences**—such as biology, pharmacy, chemistry, or a related discipline—alongside prior **experience in a QA role within a GMP environment**. Candidates need meticulous document administration skills and proven capability handling deviations, change controls, and CAPAs. Because Anocca operates in an international environment, excellent communication skills in fluent written and spoken English are mandatory. Prior experience with regulatory guidelines for ATMP (EudraLex Vol. 4), aseptic processing (EudraLex Annex 1), or microbiology represents a significant asset.
Join Our Team as a QA Manager
We are looking for a full time Quality Assurance Manager to join and strengthen the GMP Operations team at Anocca.
The GMP operations team currently consist of a production team, a QC team, QA managers including QP, facility manager, validation and project managers, for a total of approximately 30 colleagues.
You will be involved in the quality assurance of all operative activities, including document approval, deviation investigations, material release, training of employees, validation of equipment, maintenance of the Quality Management System (QMS) and validation of methods for release of ATMP products, to be used in clinical trials. Also, document administration will be an important part of this role.
Previous experience in Quality Assurance (QA) within a GMP environment is required for this role'
Experience in regulatory guidelines for ATMP (EudraLex Vol.4), aseptic work (EudraLex Annex 1) or in microbiology would be a significant asset.
You must be capable of working as part of a team and as the company and team is very international and the business language is English, excellent English communication skills both in speech and in writing is required.
The role is suited to motivated persons with a drive to learn and grow in a complex and varied environment.
What we are looking for:
• BSc or MSc in life science subject (biology, pharmacy, chemistry or similar)
• Previous experience in QA role
• Meticulous documentation administration skills
• Experienced in deviation investigations, CC and CAPAs
• Fluent written and spoken English
We offer:
An international workplace with plenty of variety in the job, interaction with all other Anocca employees and the opportunity to work at the exciting intersection of biotechnology and medicine.
Compensation:
• Monthly salary
• Tier 1 occupational pension plan
• Wellness grant
• Flexible work hours
How to Apply:
If this QA position resonates with you, we would love to hear from you. Submit your application, including your CV and a cover letter, through our careers portal. Join us in making a difference, apply now!
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