Overview
Quality Assurance Operations Manager Jobs in Braine-l’Alleud, Walloon Region, Belgium at PlusOne – Biotech, Medtech, Hightech Talents
Title: Quality Assurance Operations Manager
Company: PlusOne – Biotech, Medtech, Hightech Talents
Location: Braine-l’Alleud, Walloon Region, Belgium
Our Client PolyPeptide is a specialized Contract Development & Manufacturing Organization (CDMO) supporting pharmaceutical and biotechnology customers in the development and manufacturing of peptide- and oligonucleotide-based active pharmaceutical ingredients.
To strengthen its Quality Assurance organization in Belgium, PolyPeptide is looking for a QA Operations Manager to lead and develop the QA Operations team and ensure strong quality oversight of manufacturing, in-process controls, batch documentation and product release activities.
Your role
As QA Operations Manager, you will play a key leadership role in a GMP-regulated manufacturing environment. You will ensure that production and quality control operations are executed in full compliance with GMP, regulatory expectations and internal quality procedures.
You will lead a team of QA professionals, including team leaders, and act as a strong partner to Manufacturing, QC, Supply Chain and other QA functions. Your mission will be to reinforce quality culture on the shopfloor, support timely and compliant batch disposition, and drive a more preventive and structured approach to quality operations.
Key responsibilities
- Lead, coach and develop the QA Operations team, ensuring clear priorities, accountability and engagement.
- Ensure compliant and timely review of Master Batch Records, executed batch documentation and in-process documentation.
- Supervise product and raw material release activities, ensuring traceability, consistency and regulatory compliance.
- Provide strong QA presence on the shopfloor through routine checks, Gemba walks and close collaboration with Manufacturing and QC.
- Oversee deviation management, investigations, root cause analysis, CAPA follow-up and escalation of recurring quality issues.
- Manage and approve change controls impacting manufacturing, QC and documentation activities.
- Oversee ERP master data governance related to product and quality information.
- Define, monitor and report QA Operations KPIs, including batch release lead time, documentation right-first-time and deviation/CAPA performance.
- Promote continuous improvement initiatives to strengthen documentation quality, process robustness and operational efficiency.
- Contribute to a strong quality mindset across operations, balancing compliance, business needs and operational agility.
Your profile
- Bachelor’s or Master’s degree in a scientific, pharmaceutical, biotechnology, chemistry or related field.
- Minimum 8 to 10 years of experience in Quality Assurance within a GMP manufacturing environment.
- Strong experience in batch record review, product release, deviation/CAPA management and change control.
- Proven people management experience, ideally including team leaders or sizeable operational QA teams.
- Solid knowledge of EU GMP, FDA and ICH expectations.
- Good understanding of manufacturing, QC processes, ERP systems and electronic QMS tools.
- Experience in a CDMO, contract manufacturing or multi-product/multi-customer environment is a strong asset.
- Professional fluency in English; French is an asset.
Your leadership style
You are a hands-on, structured and resilient quality leader. You are comfortable making decisions in a demanding operational environment and you know how to remain calm, pragmatic and solution-oriented under pressure.
You build credibility with production teams, challenge practices constructively and lead by example. You enjoy developing people, clarifying roles and creating a culture of ownership, precision and continuous improvement.
What PolyPeptide offers
This is a highly impactful role within a growing and complex biopharmaceutical manufacturing environment. You will have the opportunity to lead a key QA Operations team, contribute directly to product release and delivery performance, and play an active role in strengthening quality culture across the site.
You will join an international CDMO environment where quality, collaboration, operational excellence and customer focus are central to success.
QA Operations Manager – PolyPeptide Belgium
Location: Braine-l’Alleud, Belgium
Department: Quality Assurance
Reports to: Head of Quality Assurance
