BRIEF COMPANY PROFILE
|The company is a global, research-driven pharmaceutical company focusing on the treatment of chronic diseases. The history dates back to early last century. Through the establishment of subsidiaries as well as mergers and acquisitions the company has become the world leader in their treatment areas.|
|The company is looking to bring onboard an experienced, driven and high-caliber Senior Manager, Global Quality Affiliates to join the Global Quality Clinical & Markets team – dedicated to ensuring broad GDP compliance in relation to company affiliates/Sales subsidiaries and distributors/partners.
The Senior Manager, Global Quality Affiliates will be responsible for ensuring optimal daily operation support and sparring within distribution of products, technical complaints, recall and rapid alert, case handling etc. The position is located in the headquarter in Greater Copenhagen, Denmark, with close collaboration with Quality Responsible Persons particularly in the company affiliates.
The role will also be responsible for maintaining and continuously improving quality agreements across all affiliates, hereunder implementing and rolling out corporate quality processes, systems, tools – and the company Quality Kit. Moreover, the position will be driving the global initiatives to ensure local input and anchoring as part of the global quality networks for optimization and maintenance of quality processes.
Essentially, the position is a unique opportunity to take part in defining the global GDP strategy of the company. Hence, the ideal candidate for the role will not only bring relevant strategic, tactical, and operational experience and competencies within GDP and the HQ-affiliate interrelationship, but also carry a sincere desire to drive and bring forward distribution quality which ultimately improves the quality of life for the millions of people suffering from allergies all over the world. The right candidate is expected to step into a role as Senior Manager, where the candidate is assumed to be an experienced professional with management and/or project manager experience with deep knowledge of GDP and experience in the implementation and roll out of corporate quality processes from an affiliate, HQ or combined perspective. Finally, a clear drive, motivation and aspiration for leveraging oneself, peers and colleagues altogether with the ability to build and maintain strong relations across different cultures is key.
||Senior Manager, Global Quality Affiliates|
|Reporting line:||Senior Director, Global Quality Clinical & Markets|
|Reporting to the position:||Quality Responsible Persons in company affiliates (2 solid lines and 7 dotted lines)|
|Traveling:||20-30 days annually|
|Responsibilities & Tasks:
||• Managing the global group of Quality Responsible Persons in company affiliates/Sales subsidiaries in Nordic, Benelux, UK, Germany, Italy, China, France, and Turkey.
• Acting as Quality Business Partner for appointed company Affiliates, Business Development and Global Marketing:
o Providing daily operation support and sparring with distribution of products, technical complaints, recall and rapid alert, case handling etc.
o Implementing and rolling out Corporate Quality processes, systems and tools in Affiliates e.g. training system and new document management system.
o Participating in market expansion activities including supplier management and GDP audits.
o Proactively setting the quality standards for quality activities related to new business opportunities through Due Diligence.
• Establishing and maintaining Quality Agreements and company Quality kit for affiliates.
• Providing quality sparring and close collaboration with other Headquarter functions e.g. Commercial Operations, Global Pharmacovigilance, Global Regulatory Affairs and other Global Quality functions.
• Driving the global initiatives to ensure local input and anchoring as part of the global quality networks for optimization and maintenance of quality processes.
• Seamless collaboration and interaction with internal and external stakeholders, globally – especially affiliates and key HQ stakeholders.
|Key success criteria:||Key success criteria:
|Educational background:||Preferably M.Sc.-level degree within nature science, pharmacy or similar.|
|Language:||Danish and English – fluent (verbally and written).|
|Ideal experience:||• 7-10 years of experience within Quality, in depth knowledge of Quality/GMP/GDP requirements and expectations in the Pharmaceutical Industry.
• Experience from Affiliates/Sales Subsidiaries
• Working globally with different cultures is an advantage.
|Personal & leadership competencies:||Oversight
Solves tasks with great oversight navigating with some ease across multiple priorities.
Demonstrates high drive to achieve goals and executive tasks while making sure co-workers have a clear understanding of the direction of the tasks; takes action; organizes resources and direct others toward successful execution of the tasks; drives projects forward to reach pivotal objectives; makes things happen and follows through.
Is concerned with reaching and maintaining quality; sets high standards for performance and execution – for oneself and for others.
Relation- and team builder
Build relations while being a flexible, respectful and empathetic team player. Collaborates, shares information and works well with others with a view to obtain team objectives.
Able to communicate with people from other cultures, relates to problems as seen from other cultures' perspective.
Possesses excellent oral and written communication skills in English. Communicates the central issues in a discussion in a clear, fluent and precise manner, while being able to keep the recipients' attention. Produces written material, which is clear, fluent, precise and easy to understand for the recipients. Attentive to the needs of others when he/she speaks.
Proactive mindset and navigates smoothly across multiple organizational layers of stakeholders. Is able to establish and maintain relations with people at all levels – internally and externally – and makes people feel at ease.
Proactively takes initiatives while actively seeking influence and initiating actions on own initiative.
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 with diplomatic skills. Develops and maintains networks.
Works systematically; organizes work and effort; is methodical in one's performance; holds on to commenced tasks and projects. Possess the ability to plan, organize and execute multiple tasks and aim for high level of compliance.