COMMERCIAL QA MANAGER, NORDIC
BRIEF COMPANY PROFILE
Our client is a family owned pharmaceutical company and global leader within their therapy area. The company develops, manufactures and sells effective treatments and technologies to patients in many corners of the world. As a fast growing and fully integrated pharmaceutical company, our client offers support along the entire value chain - from drug development through commercialization.
Over the years and on numerous accounts, the Nordic region of ourclient has delivered best practice solutions translating into global initiatives, and the region has a clear and present voice in the formulation of global strategies.
Reporting directly to the Head of Commercial QA, EU, the “Commercial QA Manager Nordics & GDP Responsible DK, SE, NO” will be responsible for Quality Assurance procedures and Goods Distribution Practices in our client's Nordic Affiliate.
As “Commercial QA Manager, Nordics” the position will be responsible for maintaining and continuously improving the Quality Management System within our client's Nordic affiliate – hereunder driving initiatives to successfully contribute to business continuity and business expansion objectives.
As “GDP Responsible of DK, SE and NO”, The position will also assume the overall responsibilities related to storage, distribution and wholesale activities of our client’s medicinal products and devices according to EMA regulations as well as local regulations in Denmark, Sweden and Norway – including verification and review of audit documentation and licenses.
The position is a unique opportunity to participate in defining the regional commercial QA & GDP strategy of our client. The position also entails significant global exposure from best practices derived from the Nordic affiliate translating into our client's international network.
Commercial QA Manager, Nordic
Head of Commercial QA, EU
Responsibilities & Tasks:
Commercial QA Manager Nordics
Ensuring process compliance with our client’s Global Quality System, EMA regulations and guidelines and requirements set by local regulatory agencies in Denmark, Sweden and Norway.
Ensuring that the Quality Management System (QMS) is implemented and maintained in adherence to our client’s Global QMS.
Managing all Quality Assurance activities for our client’s existing and new product portfolio in the Nordic Market.
Representing Global Quality Assurance in cross-functional teams and providing strategic Quality Assurance and GDP Compliance input to support the Nordic Business Affiliate operating the markets in the region regarding our client’s product portfolio.
Providing country specific information on national cultural attitudes and our client’s reputation among customers and patients to our client’s global headquarters so that such information can be incorporated into our client’s global business strategies.
Providing support as needed to the Nordic Business Affiliate for local and regional in-licensing and out-licensing activities.
Providing support to the Global Quality Assurance-External Supply Quality team (ESQ) to manage any third-party processes and activities in the Nordic Region.
Collaborating with the Commercial Quality Manager UK/IE on continuously improving and operating the Quality System and Quality Manual for the Nordic & UK/IE Cluster.
Managing and processing incidents, deviations, CAPAs and change control in the Nordic region.
Manage the Product Quality Complaints System including escalation of issues to the Product Incident/Recall Committee.
Promptly executing recalls based on the instructions and recommendations of the Product Incident/Recall Committee in the Nordic region. Hereunder, coordinating with Global functions and notifying national regulatory agencies.
Participating in the local Crisis Management Team acting as the cGMP/GDP Subject Matter Expert potentially escalating critical issues to the Product Incident/Recall Committee.
Promoting continuous improvement of our client’s local and global quality procedures by analyzing Quality KPIs and derive measures for possible process and product improvements.
Sharing best practices from the Nordic Affiliate with our client’s global network.
Advising the GM of Client Nordics and employees of cGMP/GDP risks that will have an impact on the business operations in the Nordic region.
Good Distribution Practice (GDP) Responsible
Maintaining Wholesale Distribution Licenses for our client's nordic affiliates.
Executing regular cGMP/GDP training for personnel whose activities impact on product quality.
Defining an annual schedule and performing, in cooperation with Global Functions, self-inspections of business processes which have an impact on GDP processes and product quality and identity.
Documenting incidents and deviations that impact the quality and identity of medical products/devices and GDP processes and records.
Assembling Product Incident/Recall Committee and implement, manage and audit CAPAs where such are required to correct any critical issues based on approved plans and timelines with the affected business process owners.
Ensuring that product complaints are evaluated, processed and investigated. Hereunder reviewing and archiving all subsequent investigation reports and distributing these to necessary external stakeholders in compliance with our client’s procedures and local regulatory requirements.
Verifying and reviewing audit and qualification documentation of all suppliers, transportation and distribution services, and customers to ensure that these have been audited, licensed, qualified and approved by our client’s Global Quality Assuance, ESQ and local regulatory agencies.
Reviewing, approving and documenting any subcontracted activities which may impact on product quality and identity and GDP processes.
Inspecting and making final disposition of returned, rejected, recalled or counterfeit products. Hereunder, approving any returned products to saleable stock.
Following requirements set by local regulatory agencies regarding medicinal product import and disposition in Denmark, Norway and Sweden and executing processes outlined in our client's SOP's.
Key success criteria:
Successful and continuous management and improvement of Quality Assurance activities and Quality Systems in the Nordic Business Affiliate in compliance with our client's Global Quality System, EMA regulations and local regulatory agencies in Denmark, Sweden and Norway.
Successful management and processing of incidents, deviations, CAPAs, complaints/recall and change control procedures in the Nordic region in agreement with the Product Incident/Recall Committee.
Successful fulfillment of the duties of the GDP Responsible person as defined in EMA regulations and local regulations in Denmark, Sweden and Norway.
University degree in Pharmacy or other Natural Sciences.
English and one Scandinavian language – fluent verbally and in writing.
Ideal experience and competencies:
Strong track record and extensive experience in Quality Assurance within the pharmaceutical and biotechnology industries in any of the Nordic countries.
A solid working knowledge of applicant EMA and local regulations and guidelines for medicinal products and devices.
Proven track record of managing projects within Quality Assurance.
Experienced in improving cGMP and GDP processes.
Appropriately trained regarding quality topics within the pharmaceutical and biotechnology industries.
Is concerned with reaching and maintaining quality; sets high standards for performance and execution throughout all processes.
Defines a clear vision. Looks beyond the immediate difficulties and focuses on the far-reaching consequences; sees things in a broad perspective; takes tendencies in the environment into account when planning and developing strategies.
Divides problems into relevant parts; sensitively integrates the analytical output into the given context; differentiates between key areas and irrelevant and less important areas; has a logical mind-set; makes sensible decisions on the basis of available information; is able to get an overview of a specific situation and at the same time work detailed with a problem; uses details to gain an overview of a situation.
Communicates the central issues in a discussion in a clear, fluent and precise manner, while being able to keep the recipients' attention and being attentive to the needs of others when he/she speaks. Produces written material, which is clear, fluent, precise and easy to understand for the recipients. Possesses excellent presentation and facilitation skills.
Stakeholder management & networking
Is able to establish and maintain relations with people at all levels internally as well as externally and make people feel at ease. Achieves agreement by dealing with disagreements and potential conflicts using diplomatic skills. Develops and maintains networks.
Results and goal orientation
Is ambitious while establishing visible and achievable goals for co-workers. Focuses on action, activities and results. Is able to continue working on a specific problem, viewpoint or action plan until a result has been achieved, or it is determined that an alternative approach is needed.
Structure & Detail
Works systematically; organizes work and effort; is methodical in one's performance; holds on to commenced tasks and projects; has a good sense of detail.
Is undeterred and persistent despite resistance and difficulties, carries on when faced with adversity.
Maintains a high ethical standard personally as well as professionally. Shows integrity and a sense of justice in the togetherness with others. Is reliable and trustworthy.