Well-respected Biotech in Belgium need a VQL for an initial 12-month assignment to Join their dynamic team, driving strategic and operational Quality Assurance activities for Global Vendors in GMP manufacturing. You will Collaborate with internal stakeholders, manage deviations, KPIs, Quality Agreements, stability programs, and product reviews. You will also act as the central QA point of contact, ensuring compliance and optimal vendor performance. The role encompasses covering the entire product lifecycle, from commercialisation to phase-out as well as contribute to audits, handle complaints, and manage vendor-related documentation. Elements of the role will involve you being a key player in Vendor Risk Management and support customer audits and Health Authority inspections.
The role is hybrid hourly rate / Freelance and require you to be onsite in Braine - / Brussels
Responsibilities:
- Central QA point of contact for vendor-related investigations
- Manage key operational QA metrics for vendors
- Ensure compliance with Quality Agreements and perform periodic reviews
- Oversee Annual Product Stability Program and Product Quality Reviews
- Participate in vendor meetings, handling quality complaints and investigations
- Provide expert QA advice for technical operational and general QA matters
- Own QA plans and product resource overview for assigned vendors
- Manage documentation and support audits/inspections
- Act as a substitute for other Vendor Quality Leads when needed
Experience Needed:
- 6-10 years in pharmaceutical/biologics industry in a quality management role
- Operational GMP experience is advantageous
- Regulatory interaction and auditing expertise
- Strong technical understanding of manufacturing and analytical testing
Competencies:
- Fluent in English (verbal and written)
- Broad knowledge of global pharmaceutical industry regulations
- Ability to act independently in complex situations
- Strong auditing capabilities and interpersonal skills for influencing senior personnel
Please contact me ASAP or forward your resume and I will respond immediately.
