Senior QA/QC Leader — ISO 17025 & GMP

Probi LLC; Lund; On-site; SEK 1,000,000 - 1,500,000; Full time

Job summary

Probi AB in Lund, Sweden, is seeking a Quality Manager to lead QA and QC functions, ensuring regulatory compliance and high product quality for probiotic products manufactured by external partners and tested in qualified laboratories.

You will oversee the QMS, CAPA, deviations, and training, collaborate with suppliers, regulators and cross-functional teams, and drive continuous improvement while representing Probi in audits and customer discussions.

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.

Responsibilities

• Lead and manage 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 issues are escalated immediately.
• 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.
• 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.
• Ensure adherence to local, regional, and international regulatory standards (e.g., ISO, GMP).
• Collaborate with third-party manufacturers and testing laboratories to uphold quality standards.
• Represent the laboratory in technical discussions with accreditation bodies (e.g., Swedac) and customers.
• Monitor quality metrics and address performance gaps.
• Review nonconformities, CAPAs, and risk assessments related to technical validity, impartiality, and data integrity
• Oversee preparation, maintenance, and storage of all quality-related documentation.
• Approve and release QA and QC documents, including SOPs, validation protocols, and reports.
• Represent Probi during audits and regulatory inspections.

Skills

QA/QC leadership

Regulatory knowledge

Cross-functional collaboration

Problem solving

Communication skills

Education

Master’s degree in Life Sciences, Quality Management, or a related field

Tools

Quality management software

Job description

Probi AB in Lund, Sweden, is seeking a Quality Manager to lead QA and QC functions, ensuring regulatory compliance and high product quality for probiotic products manufactured by external partners and tested in qualified laboratories.

You will oversee the QMS, CAPA, deviations, and training, collaborate with suppliers, regulators and cross-functional teams, and drive continuous improvement while representing Probi in audits and customer discussions.