Head of Quality Assurance
Permanent / CDI role
We are working on behalf of a multinational pharmaceutical client, with sites throughout continental Europe. They are seeking a Head of Quality Assurance at their Brussels site. This is a permanent / CDI role and attracts a very competitive employment package including bonus and company car.
What you’ll do:
This position will be responsible for leading and managing all our clients QA programs, activities and staff to ensure compliance with global regulations. This role will provide strategic, tactical, and technical/operational guidance regarding GMP compliance with current pharmaceutical laws and regulations. The incumbent will work closely with the Vice President of Compliance, to plan and coordinate all necessary QA activities. She/He will be responsible for providing compliance oversight of all contractors/manufacturers and will have the ultimate authority for disposition of commercial products.
The Head Of QA will manage the Quality Assurance Department and will report into the Site Compliance Manager.
- Developing and implementing the Quality department’s strategy, providing direction and guidance to the Quality team.
- Implementing and maintaining a Quality Risk Management system (EU GMP Part III Q9).
- Ensuring that all activities are performed in accordance with GMP, company SOPs and Health and Safety policies.
- Managing all validation/qualification activities, including validation/qualification strategy and approval of protocols and reports
- Maintaining an awareness of new and proposed legislation that impacts the business and communicating any changes to the Senior Management Team (SMT).
- Preparing, reviewing and approving Technical and Quality Agreements.
- Leading customer and regulatory audits/inspections, as required.
- Ensuring that the Quality department meets or improves on budget, cost, volume and efficiency targets (KPIs) in line with business objectives.
- Managing, motivating, coaching and mentoring direct reports, to higher levels of management capability.
- Preparing and justifying the Quality department’s budget.
- Actively contribute to continuous improvement plan of our client and Managing Operational Excellence initiatives.
- Developing and implementing a Quality System based on Business processes approach.
- SOP and Policy writing in accordance with the cGMP and our clients Policies
- Customer relationship:
- Act as point of contact in case of customer audit
- Act as customer audit contact for the responses
- Act as customer audit contact for all question regarding the clients compliance aspect
Minimum experience required:
- Min 5 years experiences in a similar position in a GMP environment is desired
- Master degree sciences (or equivalent)
- Language requirements: English (written and spoken), French (written and spoken). You must of a linguistics standard to be able to work in both languages.
Specific competences required:
- Perfect knowledge of cGMP in a regulated environment (ICH guidelines)
- Knowledge of quality systems in cGMP environment (21 CFR part 11)
- Excellent accuracy and attention to detail
- Excellent interpersonal skills (Team spirit, Open for the constructive discussion,…)
- Working knowledge of MS office packages (Word, Excel, Power Point) and TrackWise® System is in asset
- Strong problems solving skills, issue resolution and root cause analysis
- Knowledge in Lean Tools is an asset
- Highly Flexible and Adaptable. Able to work independently in a fast paced multitasking environment
On this occasion, LiCa Scientific is acting as an employment agency.