Vacancy for a Chief Regulatory and Quality Officer
Full time position
The role entails a broad range of duties and the specific areas of focus will be dependent on the skills and experience of the person holding the role.
The basic responsibility is to ensure that Glycostem has a clear Regulatory and Quality strategy which will ensure cost effective and smooth product approvals and n ever updated quality system.
The R&Q Manager:
- is a member of the Executive Management Team; and
- will help increase the awareness of regulatory and quality standards throughout the organisation.
- Maintain good contacts with global competent authorities
- Review and approval of the rationale and impact assessment related to any (substantial) changes to the manufacturing process or product under the Pharmaceutical Quality System where there is a potential impact on the quality, safety and efficacy of oNKord®
- Functioning as a regulatory point of contact for Glycostem’s external partners, companies, or organisations for oNKord® related regulatory questions
- Informing Glycostem on any potential (upcoming) ATMP regulatory or guidance document changes which may impact oNKord® product development and authorisations
- Independently manage review and approval of executed manufacturing records, analytical data, and associated documentation, including deviations and investigation reports related to production and disposition in concert with the Qualified Person
- Train staff and approve quality investigations
- Review and approval of change control requests to ensure compliance with all applicable requirements
- Prepare, execute and report in internal audit and vendor management programs
- Prepare and present quality metrics
- Independently initiate and approves SOP updates and creation of new SOPs. Additionally, oversee review of SOPs and associated documentation to ensure review requirements are met
- Lead quality representatives for regulatory inspections
- Establishment of quality-specific documents in cooperation with applicable departments (e.g. Quality Risk Management Plan, Quality Agreements, Site Master File and Validation Master Plan)
- Ensure Quality processes across the supply chain comply with all applicable regulations and guidelines
Education, skills and experience
The job as R&Q Manager will be held by a person with:
- 5-10 years of industrial experience within ATMP
- Ability to implement complex regulatory details in a simple strategy while adhering to relevant regulations
- Overlook and run a cost effective quality system
- Work effectively with other Executive Team members
Duration of employment:
- After a successful trial period a permanent contract is extended.
E-mail our HR department at Bianca@Glycostem.com for more information about Glycostem and the selection process.
Recruiters should not contact us.