Quality & Regular Affairs Manager & Local Safety Officer

• Responsible for quarterly mandatory reporting of Quality Report including CAPA’S of all entities to the B. Braun MT
• To act as a Project Manager for QA projects self-initiated or initiated by the Group & as a country point of contact in Global meetings providing feedback on local activities
• To keep abreast proactively of new laws and regulations and inform, instruct, train businessowners about them
• To lead team members empowering them on their personal development, talents, securing needs & initiatives, driving development of key skills in the team and in the wider company
• Responsible and authorised to report issues of concern directly to Managing Director at any point

Quality Assurance

• Responsible Person for all B. Braun Medical entities in the Netherlands & in Belgium, with regards to GDP. The responsibilities include and are not limited to:
• ensure implementation and maintenance of a Quality Management System based on legislation, relevant GXP and ISO 13485
• Focus on the management of authorized activities and the accuracy and quality of records
• Ensure that initial and continuous training programs are implemented and maintained
• Coordinate and perform promptly any recall operations of medicinal products and medical devices
• Ensure that relevant customer/patient complaints are dealt with effectively
• Perform the qualification and approval of suppliers and customers
• Guard & approve any contract between the Contract Giver and the Contract Acceptor which specifies their respective responsibilities relating to wholesale distribution and/or transportation of medicinal products and medical devices
• Ensure that internal audits are performed at appropriate regular intervals following a prearranged program an de necessary corrective measures are put in place
• Delegate duties when absent and keeping appropriate records relating to any delegation
• Be involved in any decision to quarantine or dispose of returned, rejected, recalled or falsified products
• Authorize the return to saleable stock of any returned medicinal product and/or medical device
• Ensure adherence of any additional requirements imposed on certain products by national law, as foreseen in Article 83 of Directive 2001/83/EC and the MDR Regulation 2017/745
• Ensure processes needed for the quality management system are documented      
• Ensure reporting to Central Services & Change Director on effectiveness of the quality management system and any need for improvement
• Draft & plan promotion of awareness of applicable regulatory requirements and quality management system requirement throughout the organisation in close collaboration with Central Services & Change Director
• Ensure that B. Braun Medical BeNe and its Care entities comply with all regulations and laws pertaining to their QA part of the business, including proposed and final rules to determine potential impacts on organizational processes
• Work with federal, state, notified bodies and local regulatory agencies and personnel on specific issues affecting their business i.e. working with such agencies as the FAGG and/or IGJ (medicinal products, medical devices and care)
• Manage activities such as notified body audits and regulatory agency inspections
• Control budget, allocate resources and workloads in collaboration with Central Services & Change Director
• With regards to Responsible Person for Information (RIP) responsible to ensure compliance of the company., responsibilities include, but are not limited to:
• Ensure conformity of translation o& alignment of local labelling, SmPC and PIL
• Approve on advertising projects marketing materials toward HCP’s and general public
• Responsible for information provided by the company
• Oversee training of medicinal representatives who visits HCP’s
• Ensure compliance of regulations on samples, premiums or advantages
• Establish & maintain an internal procedure for approving advertising & various promotional activities
• With regards to Clinical trials, responsible to ensure that the company guidelines on clinical trials (based on Good Clinical Practise) are known and followed in the local organisation

Regulatory Affairs

• To cooperate with the RA departments of the international B. Braun Group organization, take actions for the registration/notification of new Medicinal Products, Medical Devices, Biocides, in the Netherlands and/or Belgium to ensure timely submission and follow-up of variations of existing products and the associated packaging texts, keeping documentation up to date
• To collaborate with sales and marketing departments organizing price and/or reimbursement dossiers and responsible for submitting & follow-up of the dossiers
• To provide regulatory guidance to departments regarding marketing of products ensuring regulatory agency requirements are met

Local Safety Officer
Based on HC-DDDD-D-4-2-02-001490 
 

• To establish and maintain/managing the BBM’s Pharmaco-/Materio-/ Veterovigilance system on local/national level including sufficiently trained personnel aware of the Vigilance related responsibilities
• Providing the necessary means for the collection and notification of any adverse reaction occurring in the local/national territory the given timeline (in cooperation with Quality Management and and Global Pharmacovigilance & Patient Safety department)
• Receipt, documentation and forwarding of individual case safety reports (ICSRs) and reported special situations such as outcomes of use of medicinal product during pregnancy, adverse reactions during breastfeeding, reporting of lack of efficacy, overdose, abuse, misuse, occupational exposure and medication errors. Requesting additional information from the reporter if necessary. Forwarding of all ICSRs and any further safety-related information within the predefined timeframe to GPVS. Reporting to national authorities according to national regulatory requirements, if applicable
• Filing and archiving of source documents and all case-related correspondence
• Screening of new and revised national regulations and guidelines and immediately informing GPVS about relevant changes
• Regular screening of national literature for ICSRs and for new information with possible relevance for drug safety
• Regular screening and documentation of local/national safety data bases and web sites (public or with restricted access) hosted by authorities as requested by local/national law
• Organisation and documentation of training of local personnel potentially receiving drug safety relevant information
• Execution and co-ordination of actions according to local legal requirements with regard to drug safety in coordination with GPVS
• Information and co-ordination regarding authority actions related to drug safety on the local level.
• Reporting every announcement, conduct and outcome of inspections or audits of their pharmacovigilance system to the QPPV at GVPS
• Documentation of dissemination of safety communication materials to national Health Care Professionals 
• Performing of initial qualification audit and regular audits of local PV service providers or delegation of performance to adequate personnel.
• Communication with the QPPV at GPVS Department at BBM DE.
• Single contact point for national competent authorities on a 24 hour/7-days basis

Education/Professional experience

• Academic degree (as for RP role BE degree of pharmacist)
• 10 + years of experience within a comparable role in the healthcare sector
• Experienced in change management environments / processes
• Experience in working in a matrix organisation

Necessary skills/attitude

• Quality & business focussed
• Pragmatic & strong influencer
• Result-oriented & service mined
• Flexible & pro-active
• Analytical & problem-solver
• Structured & process minded

Knowledge
 

• Good business knowledge and understanding
• Thorough understanding of medical product distribution, product knowledge
• Knowledge of quality & safety developments in care sector
• Knowledge in MS office package (Excel advanced)
• Expert in all quality & regulatory topics
• Expert knowledge in ISO norm & GDP-standard
• In depth knowledge & vision on Quality Management Systems, procedures & processes
• Good knowledge of medical & medicinal legislation
• Excellent written and spoken Dutch and English skills, French & German are an asset.