QA Systems Manager (m/f/d)

unisite ag delivers employer‑branding and talent‑management consulting to firms in chemistry, pharma, biotech, medical‑device and life‑science sectors. For its client Pentapharm AG, a Swiss SME that supplies active ingredients for personal‑care, pharmaceutical and haemostasis‑diagnostics products, the company seeks a QA Systems Manager to join the Quality Assurance team. The role centres on keeping the Quality Management System running smoothly and staying compliant. Daily tasks include administering the electronic QMS and training platforms, handling document control, user rights and training records, and supporting onboarding and off‑boarding. You will draft, review and update Quality Agreements with customers and suppliers, keep the Site Master File current, and lead the yearly Product Quality Review process. Managing customer complaints, coordinating investigations and CAPA actions, acting as the Quality representative for Change Control, and preparing QA sections of customer questionnaires are also key duties. In addition, you will assist with customer audits and regulatory inspections, ensuring all QA documentation meets GMP/GDP and data‑integrity standards. The position requires a master's degree in Biology, Chemistry, Pharmacy, Quality Management or a related scientific discipline, together with more than ten years of experience in a GMP‑ or ISO‑regulated production setting. Candidates must possess solid knowledge of GMP requirements and Quality Management Systems, hands‑on experience with electronic QMS and document‑management tools, and a thorough grasp of complaints handling, CAPA, Change Control, training management and audits. Familiarity with pharmaceutical quality standards, excellent German and English communication skills, the ability to work independently while collaborating across functions, strong organisational and detail‑oriented habits, and confidence with common IT and digital quality tools are also essential. A basic understanding of the In‑Vitro Diagnostic Regulation (IVDR) is considered an advantage. The role is based in Aesch, BL, offering the chance to work closely with internal stakeholders and external partners in a collaborative environment focused on continuous improvement and regulatory compliance. What the role asks for: - MSc in Biology, Chemistry, Pharmacy, Quality Management or related field - Over 10 years experience in GMP or ISO regulated production - Strong understanding of GMP requirements and Quality Management Systems - Hands‑on experience with electronic QMS and document management tools - Knowledge of complaints handling, CAPA, Change Control, training and audits - Familiarity with pharmaceutical quality standards and regulatory requirements - Very good written and spoken German and English communication skills - Proven ability to work independently and take ownership - Strong organizational and detail‑oriented work style - Confident user of common IT systems and digital quality tools - Basic knowledge of IVDR (advantage)