This job is currently Archived,
Quality Assurance Project Manager - Belgium
Keyrus Biopharma (company)
Posted on : 10 April 2017
We are looking for a QA Project Manager for one of our clients.
Role and main tasks:
You will perform all or a combination of the following activities within the Corporate GMP Quality Assurance function:
- Understand the overall QMS Project, ongoing workstreams and affiliate impact of proposed processes, policies and documents
- Drive process gap assessment collection across the affiliate quality network (all regions), collect and consolidate feedback
- Understand feedback and impact on relevant existing processes, utilize that insight to prepare thorough action plans, including if regional SOPs will be created or if regional associated instructions would be created, deviations, change controls, etc.
- Launch action plans and monitor implementation together with relevant affiliate colleagues
- Develop a project plan to monitor affiliate implementation progress and challenges
- Develop an overall project roadmap to understand key milestones, deliverables, target dates and implementation progress
- Work closely within the project's internal and external network to ensure alignment and robust project knowledge and overall project management
- Work with the hiring manager to ensure robust communications are developed for the project including targeted affiliate communications
- Bachelor of Science Degree in Life Sciences or a related field
- Minimum 2 to 5 years within a regulation-focused area of the pharmaceutical industry, medical device industry is a plus (i.e. QA, Drug Safety, Regulatory Affairs or equivalent experience)
- Understanding and Familiarity with GxP regulations and quality system management.
- Must have experience of managing at least one quality system (deviations, change control, product complaints, etc.)
- Must possess strong writing and excellent organizational skills.
- Must possess strong communication skills
- Proficient with the use of computers and MS Office including programs for data management (e.g. Excel, database programs)
- Working knowledge and practical use of the TrackWise QA tool.
- Ability to work in a multi-cultural team to coordinate and drive results ensuring input from all team members.
- Ability to work independently, analyze complex information, make decisions and work effectively within a team environment.
- Extremely positive and motivated attitude.
- Ability to adjust to changes in processes and project priorities. Open attitude to change.
What we offer
- 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.