Role and main tasks:
- Monitoring and overseeing all the local QA activities from a QA standpoint
- Ensuring consistency of all the local GxP related activities and requirements,
- Ensuring proper bi-directional communication on quality topics related to the serialization project between the global organization and local affiliate QA
- Being the first point of escalation for quality issues related to serialization at the local level,
- Supporting the affiliate ad-hoc for quality-related activities (e.g. issue/review/approval of change controls, complaints, deviations, writing/reviewing SOPs…)
- Maintaining knowledge in the overall EU and different country regulations to be in a position to positively challenge different stakeholders
- Experience in the pharmaceutical industry and good understanding of supply flows and complexities
- Experience of working in QA for minimum 3-5 years
- Experience in serialization projects is strongly preferred
- Experience in cross-functional project management
- Good understanding of quality aspects, knowledge of GxP and applicable regulatory framework, and more especially knowledge of EU Falsified Medicine Directive (2011/62/EU), and its delegated act (Commission Delegated Regulation (EU) 2016/161), GS1 standards, as well as computer systems validation requirements
- Must possess excellent interpersonal, multi-cultural, verbal, and written English communication skills.
- Must be competent in driving cross-functional projects.
- Must have the ability to analyze data and information to draw conclusions and make effective recommendation for endorsement by management while taking into account the balance or compliance and business risk.
- Must possess strong influencing and negotiating skills.
- Must be able to effectively interact with and influence internal and external groups.
- Must have leadership and organization skills.
- Fluent in English and French
- Excellent organizational, analytical, and listening skills to ensure the serialization-related activities at the local level are in compliance with individual regulatory agencies’ expectations yet ensuring consistency across the different countries.
- Ability to coach local QA staff and colleagues.
- Excellent ability to evaluate information, take initiative and strive for lean, yet fully compliant, processes.
- Must have the ability to effectively manage numerous projects at one time
- Analytical mindset: ability to operate in a complex environment and divide bigger issues into smaller, more manageable activities.
- You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…).
- Each employee will be welcomed with a varied integration program.
- We invest considerable time and resources in training our staff (technical and non-technical courses).
- You will join a dynamic and international environment with enthusiastic and professional colleagues.
Who We are
- Our company is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence.
- Our ‘human’ approach to service provision is what differentiates us from our competitors.
- Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
- We’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
- From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Bio statistics, Medical Writing & Medical Information, Real World evidence services.