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Quality and Risk Area Manager  - Belgium  

Company managed [?] Still accepting applications

Posted on : 01 May 2017

Project Description

Business Line

Consulting Services

Job Description

We are looking for a Quality and Risk Manager (QRM) , for one of our clients based in Brabant Wallon.

Job Purpose:
The Area 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 manager integrates, prioritizes and escalates risk and compliance issues of the respective department area. The manager as per her/his level of expertise & seniority, will drive and deliver projects independently.


Key Responsibilities:

  • Ensures local training created to meet departmental needs is aligned with 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
  • As risk facilitator, supports the product risk management framework implementation, including risk identification, assessment and prioritisation and the definition of mitigation plans
  • Coordinates and interprets transversal risks in the area of support and provides recommendations
  • Coaches business on L1 (1st level controls) principles and implementation activities, develop transversal tools and Level 1 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 learning, informs relevant Center of Expertise lead(s) accordingly, in collaboration with relevant QA teams.
  • Resolve 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 MFTs, 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. Attends forums and works in collaboration with the QRM Center of Expertise. 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

Profile

Education:

  • 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)

Required Experience & Knowledge

  • 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
  • Delivers 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
  • Open thinking mind set
  • Flexible thinking, build on other expertise

What we offer

Our 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

Keyrus Biopharma, member of the international group Keyrus, is a European full-service Contract research organization (CRO) providing biopharmaceutical, nutritional, cosmetic, animal health and medical device industries with a broad range of clinical research services from early- to late-stage clinical development, including regulatory affairs, project management, clinical monitoring, scientific and medical support, site management, biostatistics, data management, product safety, quality assurance and medical & scientific communication.

Category

Quality Assurance

Location

Belgium

Contact person

Beverley Ebara