04.04.2022

Quality Assurance Expert

Precirix is a clinical-stage biopharmaceutical company dedicated to extending and improving the lives of cancer patients by designing and developing novel radiopharmaceuticals, using camelid single-domain antibody fragments labelled with radioisotopes. The company’s lead product, CAM-H2, is being evaluated in a Phase I/II trial targeting metastatic HER2-positive cancer. In addition, the company has several pre-clinical programs leveraging the technology strengths.

For the expansion of our CMC / manufacturing team, we are currently looking for an enthusiastic and experienced Quality Assurance Expert.

Purpose of the Position:

As QA Expert you will be responsible for creating and supporting the quality mindset and culture within Precirix by driving compliance activities with input from experts in the different areas as needed. The QA Expert will be responsible to develop and maintain effective quality processes and efficient procedures and identify opportunities for improvement for all Precirix departments.

At present all GxP activities at Precirix are delivered through vendors (CROs, CMOs). QA management at Precirix must be tuned to this fact, introducing appropriate internal tools and practices whilst securing full compliance of outsourced activities.

The QA Expert will report to the CTO.

Key Responsibilities

Company QMS

  • Ensure that decisions and practices are compliant, at all levels of the company
  • Develop and maintain Precirix’s QMS system, focusing on CMC / manufacturing and ensure it is recognized and understood across Precirix
  • Ensure quality standards, procedures, guidelines and methods are implemented within Precirix. Maintain employees’ training records and organize training sessions when required
  • Lead quality efforts cross-departmental

Qualification of Vendors

  • Evaluation and qualification of vendors in GxP regulated environment
  • Ensure quality agreements are in place with all GxP vendors, meeting Precirix QA objectives
  • Establish an auditing plan covering all vendors, perform or oversee onsite quality audits and ensure the follow up of resulting CAPA plans

CMC / Manufacturing Quality Assurance

  • Develop, maintain and ensure compliance with company quality and GxP standards
  • Oversee all quality related aspects at contract manufacturing sites an advice project managers on quality related questions
  • Write and review SOPs, policies and batch production/testing records (both internal and from vendors) to ensure compliance and adherence to regulations and GMP operations
  • Manage non-conformances, deviations and out of specification including root cause analysis and corrective actions, in close collaboration with Precirix’ subject-matter experts.
  • Perform internal and external audits to monitor production and quality control processes
  • Monitor procedures and analyze problems to identify and report recurring issues
  • Generate targeted metrics for Management Review (QMR)
  • Oversee QA activities conducted by external consultants
  • Support IND/IMPD submissions focusing on the quality sections

Qualification and Expertise

  • Expected educational qualifications: MSc or BSc with relevant experience in the field of Life Sciences (Pharmaceutical Sciences, Biomedical sciences, Bio-engineering sciences, Chemistry, Biochemistry, Biology,…)
  • Minimum 5 years’ experience in CMC / manufacturing quality assurance. Experience of working in a GMP regulated environment is a plus
  • In depth understanding of quality control procedures and relevant legal standards
  • Understanding of basic regulatory requirements, guidance and processes

Skills and Competences

  • Ability to adhere to high ethical standards, GLP / GMP and legal and regulatory requirements
  • Ability to operate at executive level and to defend a QA position, coupled with a liking for hands on, operational tasks and problem solving
  • Excellent communication skills (verbal, written and interpersonal) and negotiation skills
  • Demonstrates strong analytical, problem-solving skills, eye for detail
  • Self-motivated with strong leadership abilities
  • Must be a result orientated multi-tasker, quick learner and able to work in a fast-changing environment
  • Fluent in English, any other language is an asset
  • Excellent computer skills
  • Continuously looking for opportunities to learn, build skills and share learning
  • Willingness to travel

We offer you

  • An environment with nice colleagues that value a cooperative environment
  • Possibility for homeworking
  • Scale up company with a lot of opportunities and entrepreneurial atmosphere
  • Company that values the QA field
  • Company with the mission to improve the life quality of patients
  • Team with different nationalities working together towards the same goal
  • Salary package according to your qualifications

Want to explore this opportunity? Mail us at jobs@precirix.com with a letter of motivation and your cv; and we will get in touch with you.

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