QA Specialist

QA Specialist, CCRM Nordic 

Looking for an exciting opportunity to contribute to the development of next-generation cell and gene therapies and to Sweden’s ambition of becoming a leader in Advanced Therapy Medicinal Products (ATMPs)? Consider applying for the QA Specialist role at CCRM Nordic. 

About CCRM Nordic

CCRM Nordic is a newly established national infrastructure for commercialization of advanced therapy medicinal products (ATMPs). CCRM Nordic is a not-for-profit company based in GoCo Health Innovation City, Mölndal that aims to build process development and GMP ATMP manufacturing capabilities during the coming years. CCRM Nordic vision is to benefit patients by enabling commercialization of advanced therapies.

Role Summary

QA Specialist 

Location: GoCo Health Innovation City, Mölndal 

Department: Quality 

About the role

We are looking for a dedicated Quality Assurance Specialist to join our Quality team, with a key focus on ensuring compliance with Good Manufacturing Practices (GMP) for Advanced Therapy Medicinal Products (ATMPs). This role supports the development and implementation of a robust Pharmaceutical Quality Management System (QMS) and contributes to the continuous improvement of quality operations in a dynamic environment. 

Key responsibilities

• Support the development, implementation, and continuous improvement of CCRM Nordic QMS in alignment with GMP for ATMPs and ISO 9001 standards.
• Oversee document lifecycle activities including drafting, reviewing, and implementing controlled documents (SOPs, work instructions, records, policies). 
• Perform and support QA typical related tasks such as: 
  • • Supplier qualification assessments, risk management initiatives. 
    • Managing change controls and quality events (e.g., deviations, non-conformances, complaints), including the execution and follow-up of CAPA actions. 
    • Planning and performing internal audits to verify compliance with GMP and other applicable standards.  
    • Supporting regulatory inspections to ensure readiness and adherence to expectations. 
• Reviewing and approving essential quality documentation including batch records, validation protocols, and analytical test reports. 
• Deliver cross-functional training to ensure consistent understanding of quality requirements and procedures.
• Collaborate with cross-functional teams to resolve quality-related issues and provide guidance. 

Education & Experience

• Bachelor’s degree (or higher) in Life Sciences such as Biology, Pharmacology, Medicine, Bioengineering, or related discipline. 
• Proven track record in Quality Assurance within the Pharmaceutical, Biotech or Life Sciences sector. 
• Strong working knowledge of Good Manufacturing Practice (GMP), ideally including specialized experience with GMP for ATMPs. 
• Demonstrated experience in establishing, maintaining, and improving QMS in regulated environments. 
• Proficient in Microsoft Office and familiar with relevant digital systems and software used in quality operations. 
• Hands-on experience with electronic Quality Management Systems (eQMS) is highly desirable 
• Prior experience working with ATMPs and in aseptic manufacturing environments is considered a strong asset. 

Personal Attributes

• Deep understanding of GMP principles and regulatory frameworks, particularly those governing ATMPs is beneficial.
• Structured and detail oriented, with the ability to manage multiple priorities in a fast-paced, evolving environment. 
• Fluent in both Swedish and English, with strong written and verbal communication skills. 
• Quality-driven, eager to learn, and solution-oriented with a problem-solving attitude. 
• Collaborative team member with good communication skills and the ability to work effectively across departments. 

What We Offer

Join a pioneering team advancing next-generation therapies in a collaborative environment with opportunities for growth and real impact on transformative medicines. 

How to Apply

Send your CV and a brief cover letter outlining your relevant experience to jobs@ccrmnordic.se. Applications reviewed on a rolling basis.