Computer System Quality Manager

COMPUTER SYSTEM QUALITY MANAGER

MindCapture offers a dynamic and rewarding work environment. We have a strong focus on candidates and believe in long-term relationships that thrive on quality contacts and insight into career opportunities. Not only for our candidates, but also for our consultants, recruiters and support staff.

We offer strong compensation packages that reward your abilities, hard work and ingenuity in achieving success.

We reward you with competitive wages and offer a strong package with additional legal benefits such as meal vouchers, eco vouchers, high health insurance (DKV) and group insurance. Depending on your seniority, a car may be provided.

We provide personalized training to let you grow in the area of

• What you like to do
• What you are good at
• Where and how you want to have an impact

Are you ready to take the lead in shaping the future of therapeutic antibodies? Your search ends here! MindCapture proudly partners with with a clinical-stage biopharmaceutical company that is developing a pipeline of differentiated antibody therapeutics. By translating immunology breakthroughs into innovative drug candidates, this company is building a world-class portfolio of innovative therapeutics in both early and late clinical stages of development. Harnessing an ingenious fusion of unparalleled antibody engineering technologies and the brilliance of their accomplished team, this visionary enterprise has built a clinical-stage treasure trove teeming with ingenious product candidates.

We offer the opportunity to:

• Seize the driver’s seat in the exhilarating world of therapeutic antibody development.
• Join a work environment in a human‐sized, dynamic and rapidly growing biotech company
• Contribute to the build out of a global manufacturing network for innovative pharmaceutical product
• Revel in a competitive salary package adorned with an array of enticing benefits.
• A flexible work environment with the possibility to work hybrid

Our partner is looking for a computer systems quality (CSQ) manager to expand their QA team. In this role you will be responsible for:

• Developing and executing CS Quality strategies, providing vital support to the QA team.
• Managing the CS Quality audit program, ensuring adherence to stringent standards.
• Leading and supporting GxP-determination and validation activities for worldwide CS systems.
• Collaborating with cross-functional partners to develop, review and manage designated validation deliverables (including System Risk Assessments and Validation/Qualification Plans).
• Expertly evaluating, testing and validating software and SOPs
• Taking the lead or collaborating on Quality projects to enhance and upgrade CS systems and processes.
• Offering invaluable guidance as a Subject Matter Expert, supporting both local and global CS QA efforts.
• Crafting and implementing QA problem reporting processes and systems, ensuring timely and effective solutions.
• Analyzing service or performance deficiencies and providing recommendations for enhancements.
• Ensuring all computerized systems meet applicable GxP regulatory and company requirements throughout their lifecycle.
• Spearheading the design and implementation of defect reduction programs, driving continuous improvement.

• You have a master or doctorate (Ph.D.) degree in Sciences, bio-informatica or Biological Engineering.
• Proven experience in computer systems validation and time spent in quality assurance/compliance function
• Expert knowledge in Software Development Life Cycle (SDLC), IT Quality Management Systems, Computer Systems Validation, internal and external audits
• Expert knowledge of CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11….)
• Experience with the implementation and maintenance of electronic Quality and Document Management system(s)
• Knowledge of relevant scientific discipline or equivalent through education and experience
• Knowledge of Gxp regulatory requirements is preferres (i.e. GCP, GLP, GMP)
• Team player and good communication skills.
• Quality-minded individual who is accurate in execution and reporting
• Flexible attitude, capable of picking up the tasks that require attention
• Proficiency with MS Office & SharePoint
• Fluent in English – working language

Are you ready to be captivated by innovation, to shape the future of medicine and to work alongside a dynamic team dedicated to making a difference? Join us now and let’s make waves in the realm of biopharmaceutical brilliance!