Director of Quality (QA/QC) – Magle Biopolymers

About Magle Biopolymers

Magle Biopolymers is part of the Magle Group – an international life science group with strong roots in dextran technology. We develop and manufacture advanced polymer-based materials used in medical products, contributing to improving patients’ lives.

As a CDMO entity within the group, Magle Biopolymers operates in a regulated environment with high quality requirements. Quality, accountability, and cross-functional collaboration are core elements of our daily work, and we continuously strive to improve our processes and solutions.

About the Position

In the role of Director of Quality (QA/QC), you will hold the overall responsibility for quality at Magle Biopolymers and act as the company’s senior quality leader. You will be a member of the management team, reporting directly to the Managing Director, and will be the primary point of contact for customers and authorities on all quality matters.

You will lead the combined QA and QC organization, with a QA Team Lead and a QC Team Lead reporting to you. A central priority in the role is the implementation of the new electronic Quality Management System (eQMS) CANEA, together with the planning and execution of the company’s upcoming GMP certification.

The position requires a strategic and hands-on quality leader with a strong regulatory mindset, solid experience from regulated life science manufacturing, and the ability to build trust with customers, auditors, and authorities.

Key Responsibilities

• Hold the overall responsibility for QA and QC at Magle Biopolymers, ensuring that the quality system, processes, and culture support compliant and reliable supply to customers

• Lead, develop, and coach the QA and QC organization through the QA and QC Team Leads, ensuring clear priorities, competence development, and effective day-to-day operations

• Drive the implementation of the new eQMS CANEA, including process design, configuration, validation, training, and roll-out across the organization, and ensure adoption of the new ways of working

• Own the customer quality interface, including negotiation, maintenance, and follow-up of Quality Agreements with customers and key suppliers

• Hold main responsibility for customer and authority audits, including preparation, hosting, response to observations, and closure of corrective and preventive actions

• Plan and execute the company’s upcoming GMP certification, including gap analysis, remediation plan, internal readiness, and engagement with the relevant authorities

• Ensure compliance with applicable GMP, ISO, and other relevant regulatory requirements, and keep the quality system aligned with evolving expectations from customers and authorities

• Oversee batch release, deviations, change control, complaints, CAPA, supplier qualification, and internal audits, ensuring timely and risk-based decisions

• Drive a culture of continuous improvement, quality by design, and data-driven decision-making across the site

• Represent Quality in the management team and report on quality performance, KPIs, and risks to the Managing Director and the Board as required

We Imagine That You

• Have a relevant academic background, e.g. M.Sc. in Pharmacy, Chemistry, Chemical Engineering, Biotechnology, or similar

• Have solid experience in QA and/or QC leadership roles from a regulated life science environment, preferably from a CDMO, pharmaceutical, or medical device manufacturer

• Have a strong working knowledge of GMP, ISO 13485, ICH, and other relevant standards, and are experienced in interacting with customers and authorities on quality matters

• Have a proven track record of hosting customer and authority audits and driving the company through certification or major regulatory milestones

• Have hands-on experience implementing or significantly upgrading an electronic Quality Management System (eQMS); experience with CANEA is an advantage

• Are experienced in negotiating and managing Quality Agreements with customers and suppliers

• Are a structured, decisive, and pragmatic leader who can balance strategic quality direction with hands-on involvement when needed

• Communicate clearly and credibly with customers, auditors, authorities, and internal stakeholders at all levels

• Speak and write English fluently (knowledge of Danish is an advantage)

We Offer

• A senior quality leadership role in an international and growing Life Science company

• The opportunity to shape and modernize the quality organization, including ownership of the eQMS implementation and GMP certification

• A seat on the management team and direct access to the Managing Director

• A professional, collaborative, and quality-focused working environment

• Opportunities for professional and personal development

Culture and Values

At Magle Group, we work according to the IMPACT values:

Innovate – we continuously develop and improve

Motivate – we engage and support each other

Positive – we approach challenges constructively

Accountable – we take ownership of quality and results

Customer – we focus on customer and patient needs

Teamwork – we succeed through collaboration

Application

We invite candidates for interviews on an ongoing basis and encourage you to submit your application as soon as possible.

For questions regarding the position, please contact Michael Ryde, Managing Director.

For HR-related questions, please contact HR Manager Rikke Tjustrup at rikke.tjustrup@maglegroup.com.

About Magle Group

Magle Group has a solid history within Life Science and has grown through strategic acquisitions. Today, the group consists of several specialized entities, including Magle Biopolymers, with a strong focus on dextran technology and CDMO services.