This job is currently Archived,
Quality Risk Area Manager - Belgium
Keyrus Biopharma (company)
Posted on : 25 April 2017
We are looking for a Quality Risk Area Manager for one of our clients.
- The Quality & Risk Manager (QRM) Manager is a business partner who promotes the development of a quality culture, supports implementation and embedding of quality frameworks and standards consistently across the respective department areas.
- The Area QRM Manager integrates, prioritizes and escalates risk and compliance issues of the respective department area.
- With the level of expertise, seniority and background the QRM manager will drive the whole area of risk and compliance, and is expected to work autonomously.
Role and main tasks:
- As risk facilitator supports the Products risk management framework implementation, including risk identification, assessment and prioritization and the definition of mitigation plans
- Ensures local training (created to meet departmental needs) is aligned with clients' training strategy.
- In agreement with the area QRM Lead : Ensures regular review and update of training curricula for the relevant department area,
- Promotes simplification of process and process documents in collaboration with the Business owners,
- Coordinates and interprets transversal risks in the area of support and provides recommendations
- Coaches business on 1st level controls with principles and implementation activities, develops transversal tools and implementation plans.
- Responsible to keep a global overview on all L1 activities and interfaces at area level. Performs long term area trending and reviews with relevant management and leadership teams.
- Aligns with L2 (quality assessments) assessment groups on a regular basis in order to ensure alignment on all quality aspects. Supports audit and inspection awareness coordinates L3 (independent audit)–L4 (regulatory inspections) preparation and supporting activities and ensures CAPA (Corrective Actions, Preventive Actions) implementation and effectiveness. Is responsible to provide oversight at area level and integrate L1-L4 outcomes and learnings, informs relevant lead(s) accordingly, in collaboration with relevant QA teams.
- Resolve consultancy questions using a risk based approach, as appropriate will liaise and/or escalate further to relevant partners.
- Ensures consistency in assessment, resolution and escalation of critical transversal issues. While attending meetings, supports the management of for-cause and serious breach situations. Identifies the appropriate Subject Matter Expert (SME) for consultation of new/draft legislation, support the SME with impact assessment on existing operations and follows up on implementation.
- Defines and promotes a consistent quality and compliance approach. Monitors, interprets & ensures visibility of the quality & compliance performance of the organisation & partners through assessment of compliance, quality trends & metrics. Escalates relevant area risks and issues to the Area QRM Lead
- Supports the roll-out of Compliance/Values initiatives, by tailoring initiatives to the areas level and informing the business/QO accordingly.
- Ensures learning from CAPA (If needed after assessment) and RA intelligence is integrated in process and associated control doc and training at all area levels
- Promotes knowledge and information sharing with other QRM area managers and local contacts
- University Scientific Degree, Master or equivalent
- Qualification in Quality Management or equivalent experience
- General Science or Life Science Degree (Pharmacy, Chemistry, Bio Engineer, Biology, Bio Medical Sciences)
- ICT Skills: Office tools
- Able to lead and work within teams and networks across functional and geographical boundaries; leads by example and promotes collaboration, effective communication and leadership in others.
- Able to set and manage priorities
- Analytical skills, including the ability to gather, summarize and interpret complex information from multiple internal and external sources
- Demonstrates conceptual, analytical thinking
- Effective at problem solving and conflict resolution
- Possesses excellent English language verbal and written communication skills, including the ability to communicate via formal and informal discussions with all levels of staff; organizational sensitivity in communications with senior and executive staff
Soft skills :
- Good team spirit and team player
- Deliver quality work, on time
- Good communication, presentations skills and negotiation skills, ability to interface with multiple partners
- Positive mind-set, able to work in changing and challenging environment
- Enterprise thinking mind set
- Flexible thinking, build on other expertise
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.