JOB OPPORTUNITY
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 POSITION

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.

POSITION PROFILE

Position title:

Senior Manager, Supplier Quality Management

Reporting line:

Director of QA Engineering and Operations

Location:

Greater Copenhagen

Traveling:

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

organization.

• Mentoring the team and leading by example to deliver

Quality Agreements with Contract Manufacturers and

Suppliers.

• 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

approvals.

• 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

compliant environment.

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

SQM department.

• Leveraging the SQM capabilities within the team while

providing compelling leadership of the team.

• Ensuring appropriate prioritization of tasks within the

team.

• 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

Delivery.

CANDIDATE PROFILE

Educational background:

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
acceptable.

Language:

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

authorities.

• 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

ISO13485:2016.

• Experience with cross functional and crossgeographical

interactions.

• Experience working with databases.

• Profound experience with MS Office.

Personal competencies:

Team orientation

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.


Communication

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.


Navigating complexity

Takes well thought-through decisions in highly complex

environments.


Continuous improvement

Champions the philosophy of continuous improvement

with a high degree of integrity fostering transparency,

reliability and trustworthiness – personally and

professionally.


Visionary/strategic mind

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.


Take control/responsibility

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.


Structure

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.


Decisive

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.

For further information:

Please contact Henrik Brabrand, Chief Consultant & Team Lead, Albright Life Sciences A/S at:


M: +45 7199 2799

E: hb@albright.dk