BONESUPPORT AB is a leading Scandinavian biotechnology company based in Lund Sweden. BONESUPPORT AB aims to become a global leader in orthobiologics by optimizing bone biology to treat bone disorders. BONESUPPORT AB develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patients own bone and have the capability of eluting drugs. BONESUPPORTs bone graft substitutes are based on the patented technology platform CERAMENT .

BONESUPPORT is searching for their next

Director Quality Management

The role is a great opportunity to join BONESUPPORT ABs dynamic and rapidly growing team.

BONESUPPORT is searching for a Director Quality Management to join its dynamic and rapidly growing organization. The company is in a strong growth phase driving increased regulatory requirements higher production volumes and continued global expansion. To meet these demands BONESUPPORT is strengthening its Quality organization with an experienced and mature leader.

As Director Quality Management you will lead motivate and develop a team of six professionals across Quality Assurance Supporting Operation and R&D with QA Expertise and release of products Supplier Quality Management QA Software Lifecylce Management Post Market Surveillance and Document Control. Your role is to further improve the structure processes and ways of working needed to build a scalable efficient and compliant Quality Management System that supports BONESUPPORTs continued expansion. The role combines strategic leadership with hands-on involvement in daily operations.

In this role you will be responsible for the companys Quality Management System (QMS) to ensure compliance with ISO 13485 MDR FDA and other applicable global regulations. A core part of your responsibility is to ensure that specified product quality is consistently achieved by driving robust processes continuous improvement and crossfunctional alignment.

This position is part of the QM/RA leadership team and serves as a strategic partner to the EVP RA & QM. You will play a key role in shaping a highperforming quality organization capable of providing cross functional support and enabling the rapid future growth of BONESUPPORT.

Examples of main tasks and responsibilities:

• Lead develop and motivate the Quality Management team.
• Structure plan and lead the work within Quality Management.
• Provide hands-on support to the team when needed and take the lead in selected quality and change initiatives.
• Ensure compliance with international standards and regulatory requirements.
• Own and evolve the companys Quality Management System in compliance with ISO 13485 MDR FDA and other global regulations.
• Drive QMS follow up and continuous improvement including process optimisation and digitalisation to enable scale.
• Collaborate closely with R&D Operations Regulatory Affairs and Supply Chain to ensure quality is integrated across the entire product life cycle.
• Establish and monitor supplier audit programs and perform supplier audits
• Safeguard quality related to contract manufacturing.

This position is based at the headquarters in Lund and reports to EVP Quality Management & Regulatory Affairs

Profile

• Academic degree
• Minimum 5 years of relevant experience in medical device and/or pharmaceutical industry
• Proven leadership and management experience
• Strong knowledge of ISO 13485 MDR FDA other applicable global regulations
• Experience building and scaling a Quality Management System
• Knowledge of QA QE Supplier Quality and Document Control
• Experience in sterile production environments is meriting
• Experience conducting supplier audits and experience with software validation is an advantage

About you

We are looking for an experience and grounded leader within medical device with experience from working within quality management. As a person you are people-oriented mature and communicative. You are solution- and business-oriented able to set priorities keep deadlines and deliver in a high-pace environment. You lead with calm clarity and integrity. You set boundaries when needed make well-informed decisions and help the team stay focused. Since BONESUPPORT is in growth phase you need to be structured and able to establish processes to enable others to succeed. Furthermore you are hands-on in your approach and have the ability to move from in-depth details to the overall perspective.

Why BONESUPPORT

At BONESUPPORT you will be working together with skilled dedicated people who enjoy working in a fast growing and innovative organization. We offer a dynamic and stimulating workplace and strive for generating great teamwork innovation passion and performance which is reflected in impressive employee engagement figures. We believe in our journey and take pride in what we do.

Information and application

In this role we are cooperating with Ethel Executive. For more information about this job-opening please contact Emma Lindén .se or Louise Brondin Månsson

Welcome with your application! Send your CV (as soon as possible since we are reviewing applications continuously) and a few lines on what motivates you to apply for the role and why you want to join BONESUPPORT.