About Probi:
Probi® is a global leader in biotic solutions, dedicated to researching, manufacturing, and delivering high‑quality biotics for dietary supplements, functional food and beverage applications. Rooted in science, and working closely with customers and research partners, Probi aims to empower people worldwide to take control of their gut microbiome, helping them live healthier, longer lives.
Founded in 1991 in Sweden, Probi has grown to serve more than 40 markets and holds numerous global patents. As part of Symrise AG, the company benefits from expanded capabilities, resources, and worldwide reach, further strengthening its position as an innovation leader in the biotics category.
Position Summary:
The Quality Manager is responsible for leading the Quality Assurance (QA) and Quality Control (QC) functions at Probi AB, ensuring that quality systems, processes, and products meet regulatory requirements, customer expectations, and company quality objectives. The role oversees internal quality support, outsourced quality activities, QC laboratory operations, and stability programs while maintaining and improving the Quality Management System (QMS) to ensure compliance with applicable regulations, industry standards, and company requirements for products manufactured by external partners and tested internally or through qualified external laboratories.
Duties & Responsibilities
Leadership & Oversight
- Lead and manage both QA and QC teams at Probi AB in Lund, Sweden, including oversight of internal QA support, supplier and CMO quality management, and supervision of ISO/IEC 17025-accredited laboratory operations.
- Support day-to-day functions and ensure that any team members technical issue is escalated immediately.
Quality Management System (QMS)
- Ensure compliance with regulatory requirements, ISO/IEC 17025, STAFS 2020:1, and applicable GMP standards.
- Oversee deviation management, CAPA, change control, document control, and training processes across QA and QC.
- Ensure QMS procedures related to laboratory activities, method validation, proficiency testing, and technical competence reflect ISO 17025 and STAFS 2020:1 expectations.
Laboratory Compliance
- Ensure the QC laboratory maintains ISO/IEC 17025 accreditation for testing and calibration procedures and complies with GMP where applicable.
- Monitor technical performance through trend data, inter-laboratory comparisons, and uncertainty evaluations.
Regulatory Compliance
- Ensure adherence to local, regional, and international regulatory standards (e.g., ISO, GMP).
- Ensure compliance with customer-specific quality requirements.
- Ensure laboratory operations meet the impartiality and confidentiality requirements of ISO 17025 clauses 4.1 and 4.2.
Collaboration & Communication
- Collaborate with third-party manufacturers and testing laboratories to uphold quality standards.
- Partner with cross-functional teams (e.g., Regulatory, Supply Chain, Research and development, Marketing, Sales) to meet business and compliance objectives.
- Represent the laboratory in technical discussions with accreditation bodies (e.g., Swedac) and customers.
- Represent the QA and QC departments in technical discussions with accreditation bodies (e.g., Swedac) and customers.
Continuous Improvement
- Monitor quality metrics and address performance gaps.
- Review nonconformities, CAPAs, and risk assessments related to technical validity, impartiality, and data integrity
Documentation & Reporting
- Oversee preparation, maintenance, and storage of all quality-related documentation.
- Ensure all technical records are accurate, traceable, and retained per ISO 17025 and STAFS 2020:1 requirements.
- Ensure QA records, audit reports, and management review documentation are maintained and available for inspection
Other Duties
- Approve and release QA and QC technical and quality documents, including SOPs, validation protocols, and reports.
- Sign off on method validation, measurement uncertainty, and proficiency testing participation.
- Represent Probi during audits and regulatory inspections.
- Authorize training and competency programs for QA/QC personnel.
- Manage team and laboratory budget and technical investments.
Qualifications
- Master’s degree in Life Sciences, Quality Management, or a related field.
- Minimum of 5-7 years of experience in Quality Assurance and/or Quality Control, preferably within the pharmaceutical, probiotics, or related industries.
- Demonstrated experience in leading and managing teams in a QA/QC environment.
- Strong knowledge of QMS principles and regulatory standards, such as ISO, GMP, and ISO/IEC 17025.
- Proven ability to collaborate with third-party manufacturers and testing laboratories.
- Exceptional problem-solving, organizational, and decision-making skills.
- Strong communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
- Proficiency in quality management software and tools.
Ready to Make a Difference?
Join Probi and embark on a journey where your skills, passion, and drive will fuel our growth and innovation in the biotics industry. Apply now and be a part of a community that values empowerment, sustainability, and making a global impact!
