Quality Assurance Senior Manager (f/d/m)

Your mission

Responsible for oversight of phase-appropriate activities including GCP quality oversight supporting active clinical trial programs.

The QA Senior Manager will support the development, implementation, and maintenance of the company’s Quality Management System (QMS) to ensure compliance with applicable GxP regulations and company procedures. This individual will play a hands-on role in supporting clinical, CMC, and vendor quality activities within a fast-paced biotech environment.

The ideal candidate is detail-oriented, highly organized, collaborative, and comfortable working in a biotech company where flexibility and initiative are critical.

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 procedural 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 inspection 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 other 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

Your profile

Education

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

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

Knowledge and Skills

• 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

Preferred Experience

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

Why us?

What we offer:

• 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.

About Us

CatalYm is a biotech company based in Martinsried near Munich, developing innovative immunotherapies to transform cancer patients’ lives by effectively engaging their own immune systems to combat this malignant disease. We are now advancing to Phase 2b studies to confirm visugromab, our lead antibody, that has demonstrated durable anti-tumor efficacy with long-lasting objective responses in relapsed and refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. Our mission is to rapidly bring our next-generation immuno-oncology products to patients in need. Are you ready to board the fast-accelerating visugromab train in Martinsried? Then join us!