Quality Assurance Senior Manager (f/d/m)

Key Responsibilities

Quality Systems Support

• Support maintenance and continuous improvement of the Quality Management System (QMS)
• Manage and track quality records (e.g.deviations, CAPAs, change controls, complaints, training records, and SOP lifecycle documentation)
• Assist with document control activities (e.g. formatting, routing, issuance, archival, and periodic review of SOPs and quality documents)
• Support implementation and administration of electronic quality systems (eQMS)
• Review and approve essential study documents, (e.g. protocols, informed consent forms, clinical study reports)
• Contribute to the development of procuderal documents (e.g. SOPs and Work Instructions)

GxP Compliance

• Support compliance with applicable GxP regulations and guidelines
• Develop a risk-based GCP quality program including drafting and managing risk registers for clinical trials
• Own and lead inspection-readiness strategy across the clinical development portfolio including planning and facilitating mock inspections.
• Represent the company in regulatory inspections audits 
• Lead or Manage external vendor audit program ensuring compliance with GxPs, applicable regulations and SOPs
• Develop and ensure execution of  risk based audit plans, oversee  audits of clinical activities and provide follow up and  timely responses to audit reports.  
• Track audit observations and CAPA commitments to closure
• Stay abreast of industry trends, emerging regulations, regulation changes, best practices related to quality assurance and GCP

Vendor and Clinical Quality Support

• Assist with qualification and ongoing oversight of CMOs, CROs, laboratories, and other GxP vendors
• Serve as primary quality contact for identified vendors and investigator sites supporting clinical programs as well as othe GCP quality events/issues (e.g. CAPAS, potential serious breach assessments)
• Lead or Manage QMS assessments for service providers and collaborate closely with oversight team in Clinical Development to ensure service provider qualification process is robust and timely
• Support vendor quality documentation review, including quality agreements and audit reports
• Support clinical quality oversight activities for early to late-stage clinical studies

Training and Documentation

• Coordinate employee GxP training assignments and records
• Maintain training matrices and ensure timely completion of required training
• Develop and implement GCP training programs for internal staff and external partners and vendors involved in clinical trials
• Assist in development of quality metrics and management reporting

Cross-Functional Collaboration

• Work closely with Clinical Operations, Regulatory Affairs, Supply Chain, and Technical Operations teams
• Support quality input into development-stage operational activities and process improvements
• Contribute to fostering a strong quality culture across the organization

Education

• Bachelor’s or Master’s degree in Life Sciences, Chemistry, Biology, Pharmacy, Engineering, or a combination of a BS or equivilant degree with relevant clinical quality and technical experience.

• +5 years of QA or GxP experience in the biotechnology, pharmaceutical, or life sciences industry with development experience and exposure to commercial operations
• Experience in a clinical-stage biotech or small company environment preferred
• Knowledge and demonstrated experienceof clinical and commercial systems supporting GCP compliance with US and EX-US regulations and guidances (e.g. ICH, EMA, MHRA, FDA), BfArM, PEI)
• Extensive knowledge of GCP guidelines, e.g. ICH E6 (R3) , EU Clinical Trials Directive No 536/2014
• Experience with electronic document management or eQMS systems preferred

• Strong organizational skills and attention to detail
• Ability to manage multiple priorities in a fast-paced environment
• Strong English written and verbal communication skills
• Collaborative, proactive, and solutions-oriented mindset
• Ability to work independently with limited supervision

• Demonstrated experience supporting Phase 1–3 clinical programs
• Demonstrated experience leading/participating in, preparing for conducting, or supporting audits and health authority inspections

• The opportunity to contribute to the clinical development of a promising, innovative cancer therapy.
• An operational role at the interface of translational research, clinical biomarkers, clinical operations, and clinical bioanalytics.
• A collaborative and purpose-driven team environment.
• Flexible working arrangements, including partial remote work while maintaining regular on-site collaboration.
• A secure, permanent employment contract with competitive compensation and attractive employee benefits.