Pharma MSAT Quality Lead
Contracting – Walloon Brabant
Your responsibilities?
- Establish and build a network with the company key stakeholders in relation to Internal and External A/MSAT for Pharma Drug Substances and Drug Products.
- Provide expert QA advice, support and management for technical operational QA and general QA matters associated with Internal & External Pharma A/MSAT, with the following focus: 2nd line troubleshooting (process and analytical)
- Process improvement and life cycle management strategy within regulatory file boundaries (process and analytical)
- Process industrialization and technical transfers (process and analytical) within commercial manufacturing facilities
- Complex investigations and CAPA plans implementation (process and analytical)
- Process validation oversight and continuous process verification (CPV)
- Implement the established governance model and process for Quality oversight of Internal and External A/MSAT for Pharma Drug Substance and Drug Products which fosters continuous quality process improvement, optimized resource utilization and key indicator-based performance monitoring
- Support assignments associated with the Products and represent the team in transversal projects and initiatives
- Work closely with Global Quality teams and Business stakeholders in an effective and efficient way
- Promote Best Quality Practices throughout the External & Clinical Supply Quality team and where possible business stakeholders.
- As required, provide Operational QA support to other projects or vendors (e.g. Quality agreement preparation, follow up on audit observations and CAPA plan implementation, …) to support other team members or the wider team.
- Upon request deputize for the Head of Pharma MSAT Quality and other Pharma MSAT Quality Leads in times of absenteeism (e.g., vacation, illness)
- Work in accordance with HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of business and professional career development
Your profile?
- You hold a degree in a Master in a Scientific/Engineering domain
- Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations.
- Has good background knowledge of the pharmaceutical industry from a business and technical perspective. Operational experience, along with a manufacturing QA background and strong technical knowledge, is a key asset.
- Must be able to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely impact activities across several departments.
- Must be able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters.
- Must have the ability to manage projects/ activities across global geographies within the area of expertise. Be capable of leading and motivating teams and demonstrate professional maturity in difficult situations.
- Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally, especially at senior management levels.
- You speak fluently French and English.
Our offer?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.