SENIOR MANAGER, SQM
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 Senior Manager, SQM position at our concerning client´s company will be a part of the QA Department and supervise the Supplier Quality Management team in the organization. As the leader of a diverse team consisting of three QA specialists (two in Denmark, one in Poland) and two new members of the department on the way in China and Poland. The job requires excellent proven leadership or project leadership skills and the ability to make quick decisions while holding a holistic view on quality and delivery. The position will also demand a large span of cross-functional leadership expertise towards stakeholders in R&D, operations, and procurement. Moreover, with a large number of suppliers and an increase in regulatory demands from the MDR and IVDR regulations, the role requires strong leadership skills to inspire change in processes while handling complexity in all aspects of the position.
Senior Manager, Supplier Quality Management
Director of QA Engineering and Operations
According to projects, but approximately 30 days a year.
Responsibilities & Tasks:
• Managing the SQM team – delegating and prioritizing
tasks and responsibilities.
• Driving change management to increase efficiency for
the SQM processes and collaborations across the
• Mentoring the team and leading by example to deliver
Quality Agreements with Contract Manufacturers and
• Being part of the supplier audit team – hereunder
taking on a strategic/leading role on supplier audits.
• Engaging with R&D and being part of the early project
development to ensure road map of supplier
• Writing and maintaining the Quality Agreements with
Contract Manufacturers, Suppliers and Distributors.
• Driving global QA SQM activities.
• Collaborating closely with Operations Management to
ensure timely and compliant product deliveries.
• Using a lean process view to constantly improve
quality processes to become efficient, lean and in
compliance with regulations.
• Participating in quality training activities.
• Keeping updated knowledge of standards, regulatory
requirements and directives applicable for Medical
Devices/IVD Providing guidance for QMS and
regulatory compliance in an FDA regulated and ISO
Key success criteria:
• Successfully driving continuous improvement and a
high-performance culture, including excellent
utilization of DBS tools.
• Building a strong performance environment in the QA
• Leveraging the SQM capabilities within the team while
providing compelling leadership of the team.
• Ensuring appropriate prioritization of tasks within the
• Drive broad cross-functional stakeholder
collaborations, alignment, and communication.
• Ability to keep the overview in situations that require
quick decisions with a holistic view on Quality and
The ideal candidate holds a M.Sc. or B.Sc. degree in
engineering, pharmacy or like. However, if the candidate
has a good technical aptitude other relevant education is
English – fluent (verbally and written).
Ideal experience and competencies:
• Preferably 5+ years of experience with project
management and/or leadership.
• Well-versed in communicating with relevant regulatory
• Excellent knowledge of applicable standards and
regulatory requirements e.g., ISO13485, EU IVD/MD
regulations/directives and/or FDA legislation.
• Documented experience in Supplier Quality
Management within Medical Devices or Pharma.
• Auditing experience, preferably as Lead Auditor in
• Experience with cross functional and crossgeographical
• Experience working with databases.
• Profound experience with MS Office.
Capable of building a strong organization based on
collaboration. Collaborates and works well with others
with a view to obtain overall team objectives. Is involving
and supporting of team members and shares
information. Excels in cross-functional and project
teams. Possesses the ability to secure open
communication based on mutual trust in a team.
Communicates the central issues in a discussion in an
open, fluent and precise manner, meanwhile 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.
Takes well thought-through decisions in highly complex
Champions the philosophy of continuous improvement
with a high degree of integrity fostering transparency,
reliability and trustworthiness – personally and
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.
Makes sure co-workers have a clear understanding of
the direction of the tasks; acts; adds energy; organizes
resources and direct others toward successful execution
of the tasks; drives projects forward to reach pivotal
objectives; makes things happen and follows through.
Inspiration and motivation
Inspires others, encourages the achievement of set goals
by promoting a sense of purpose, provides inspiration for
a positive work attitude, prompts a strong wish to
succeed in the team. Secures a feeling of mutual respect
in the team through empathy and trust.
Works systematically and is highly organized and
methodical; able to simultaneously handle and prioritize
many tasks with short deadlines, while displaying
perseverance and consistency towards commenced
responsibilities, tasks and projects.
Is determined and prepared to make timely and rapid
decisions – also when information is limited, accepts
clear action plans.
Results and goal orientation
Focus on targets, activities and results. Is able to
continue working at a specific problem, viewpoint or
action plan until a result has been achieved or it is
determined that an alternative approach is needed.