QA Manager, Södertälje

QA manager

For the Syntagon AB based in Södertälje, we are looking for a QA Manager

About us

Syntagon is a Swedish Contract Development and Manufacturing Organization (CDMO) based in Södertälje, with more than 25 years of experience in developing and manufacturing active pharmaceutical ingredients (APIs). We support pharmaceutical and biotech companies from early development and clinical phases through to commercial supply, with expertise in small molecules, peptides, purification and analytical services.

Originally founded in Södertälje in 1998, Syntagon became part of Ardena in 2018. In 2026, the business entered a new chapter when it was acquired by Nanologica and once again began operating as Syntagon. Today, we combine decades of pharmaceutical development and manufacturing experience with our culture built on scientific excellence, quality, collaboration and responsibility.

What you will work on

Your key responsibilities

The Quality Assurance group plays a pivotal role in ensuring that all our API development and manufacturing processes are executed according to GMP guidelines and to provide a development phase GMP support to the operational teams.

As a QA manager you provide leadership in ensuring continuous compliance with internal and external regulations, standards, policies and procedures related to the quality and performance of company operations.

Responsibilities

· Approve raw material QC results, IPC results and CoA.

· Approve Master Batch Production Records.

· Approve executed batch records and cleaning records.

· Release of raw materials, consumables and intermediates for manufacturing.

· Release of APIs.

· Ensure compliance with the established standards.

· Approve deviations and CAPA.

· Approve OOS.

· Approve quality specifications and test methods.

· Manage and perform GMP training for all staff.

· Manage qualification of GMP-related service providers (contract QC labs and others).

· Approve SOPs and Work Routines.

· Issue new or updated SOP, Instructions, Work Routines.

· Participate in and conduct internal quality audits.

· Participate in client audits and authority inspections.

· Issue and approve validation/qualification protocol and reports.

Your profile looks like /resembles

· You have a MSc or PhD degree within the science/technology field, preferably chemistry, biotechnology, pharmacy or equivalent.

· Experience and knowledge of GMP quality system

· Knowledge of EU & FDA guidelines and regulatory agencies expectations.

· Minimum of 3 years of GMP experience and minimum 1 year of QA experience in a CDMO company.

· You are solution driven, keeping timelines in mind.

· You are continuously looking for improvement.

· You have strong communication skills, able to listen and analyze a quality issue and explain the proposed solution in an accurate manner.

· You are flexible, a problem solver and a team player.

· You have an analytical mindset and you are comfortable in stressful situations.

· You are fluent in English.

· Experience from APIs and drug products intended for clinical trials is strongly meriting.

· Experience with relevant digital systems and software is highly desirable, including:

-Microsoft Office / Microsoft 365

-SciLife

-Microsoft Dynamics 365 Business Central

-DocuSign

-Chromeleon

WHAT WE OFFER

· A true learning environment where you will have the ability to grow your skills.

· A dynamic working environment with nice colleagues.

· Open straightforward but also caring culture.

· Generous wellness allowance.

· An attractive remuneration package.

· Flexible working hours.