SENIOR MANAGER, COMMERCIAL QA
BRIEF COMPANY PROFILE
Our client is a global leading provider of technologically advanced acute care solutions that simplify and automate all phases of acute care testing. The company’s advanced solutions and products help healthcare professionals get fast and accurate information on the most critical parameters in acute care testing. This is the foundation for making immediate and well-informed decisions on the treatment of critically ill patients in clinical settings such as emergency care, intensive care, anesthesiology, cardiac surgery, neonatal care and wound care.
The company is located in Greater Copenhagen.
The QA Commercial team is a new department located in the company headquarter under the QA function. The department is established to support quality related activities related to the sales subsidiaries and sales activities throughout the world.
The manager position is located in Denmark, but has international managerial responsibilities with the following direct reports:
1 QA Manager and 2 QA Specialists as part of China QA team, located in the Chinese sales unit in Shanghai.
1 QA Specialist, located in Denmark with the responsibility of distributor contracts, quality agreements with subsidiaries and auditing of selected distributors and subsidiaries.
The position reports to the Sr. Director of QA and is part of the Global QA Management Team.
The ideal candidate for the position has potential/run-way for future senior leadership positions.
Senior Manager, Commercial QA
Sr. Director, QA
Greater Copenhagen, Denmark
25-35 days per year
Responsibilities & Tasks:
Building up a new QA function from the start in a dynamic and changing regulatory environment.
Establishing global QA support structure to sales subsidiaries, distributors and OEM partners.
Providing leadership to China QA manager in order to:
Continuing to form a strong quality department in the China sales unit with local knowledge about regulations and requirements.
Building the ability to control limited labelling activities locally in China.
Establishing a strong link between the Chinese QA team and the headquarter in Denmark.
Establishing processes, planning and leading execution of distributor quality relations according to MDR/IVDR and ISO 13485 requirements.
Maintaining Quality Agreements with sales subsidiaries and plan/execute audit activities.
Building up QA headquarter partnership for repair activities in the company's Turkish subsidiary, ensuring that the local QA organization is sufficiently staffed and QMS processes are in place.
Keeping up-to-date on knowledge of standards, regulatory requirements and directives applicable for MD/IVD and ensure updating relevant parts of the QA system for own area.
Ensuring resource allocation and planning within the department and with relevant external partners – hence ensuring effective and timely handling of services as committed.
Conducting performance objective planning, reviews, talent assessment, hiring, budgeting and planning for the department.
Key success criteria:
Building a well-functioning Global QA Support Structure to sales subsidiaries, distributors and OEM partners.
Establishing a strong collaborative platform with Chinese QA Manager.
Establishing strong QA HQ Partnership with Turkish site.
Establishing a strong managerial and collaborative link with the China site.
Leveraging the Commercial QA capabilities within the team while providing compelling leadership of the team.
Ensuring appropriate prioritization of tasks within the team.
Successfully driving a high-performance culture focused on adding value in alignment with the business and talent management.
Fostering a strong culture to build future QA muscle.
Preferably graduate education at M.Sc.- or B.Sc.-level e.g. within engineering, pharmaceuticals or similar.
English – fluent verbally and in writing (Chinese language skills is an advantage but is not a must).
Ideal experience and competencies:
Strong QA experience – preferably from a commercial QA setting and a Medical Device background.
Demonstrated strong technical understanding and the ability to learn the technical aspects of products fast.
Demonstrated track record in incorporating best practices in applying solutions while understanding business perspectives of decisions.
Experienced in management either from larger projects or from team management – leading in a global environment, while building strong and effective teams.
In-depth knowledge of relevant standards and regulations in USA, Canada, Asia, Europe and other key markets (NMPA, FDA, ISO and MDR/IVDR).
Sound cross-organizational collaboration and project management experience.
Demonstrated ability to move strategy into action.
Preferably experience from working in a global/international setting – or alternatively, a regional/local setting.
Preferably experience from a Kaizen/LEAN/ continuous improvement-minded setting.
Experience from working across different cultures.
Experience in working on cross functional projects.
Communicates effectively in a technical organization and in a clear, fluent and precise manner – always with minor preparation. Is able to keep the recipients' attention, while remaining 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.
Inspires confidence and exhibits power and a clear route forward. Is proactive and inspires others, while taking initiatives without hesitation. Is self-motivating and actively seeks influence and starts up actions/initiatives.
Is naturally self-confident, reliable and able to push decisions through, while withstanding adverse conditions. Encourages the achievement of set goals by promoting a sense of purpose and demonstrates strong drive, stamina, natural authority, and responsibility, while prompting a strong wish to succeed within the team.
Solution and result orientation
Drives for results. Applies a solution-oriented approach to problem-solving and drives improvement actions forward efficiently within a cross-cultural context. Makes things happen, follows through, is result-oriented, persistent and motivated to strengthen team input to ensure strong organizational output. Establishes visible, achievable and ambitious goals and focuses on action and results.
Is open, outgoing and operates through trust and transparency. Collaborates and works well with others with a view to obtain the team's objectives. Shares information and supports others.
Is proactive, reliable and able to inspire others. Actively seeks influence, takes initiative and starts up actions.
Utilizes critical thinking. Maintains overview in situations that requires quick decisions, including a holistic view to quality and delivery. Intelligently divides problems into relevant parts, sensitively integrates analytical output into a given context and differentiates between key areas and irrelevant and less important areas. Applies a logical mind-set and makes sensible decisions based on available information and a strong business understanding.
Structure and prioritization
Works systematically, organizes work and effort, is methodical in performance and holds on to commenced tasks/projects with great planning and visual skills. Assesses the importance of considerations, decisions and actions, and analyses most important issues first.