Senior QA Specialist, Pragmatic, Experienced and Improvement Driven

Are you an experienced QA Specialist with a passion for quality? Do you love working cross-functionally with colleagues to develop processes and find better, more efficient ways to work? Are you dedicated to make an IMPACT in the life of others? 

Does this sound like you? Then you should consider joining us at Magle!

About the Role

As a Senior QA Specialist, you lead and coordinate QA activities across the organisation. You take ownership of complex issues, support others in making informed decisions and ensure that quality work is meaningful, efficient and risk based.

You will,

Lead and strengthen QA capabilities

• Act as a senior advisor on quality, compliance and risk based decision making,

• Drive continuous improvement initiatives, including LEAN activities and process optimisation,

• Ensure QA processes are efficient, relevant and aligned with operational needs.

Coach and build competence

• Provide mentoring and guidance to QA colleagues and cross functional teams,

• Support the organisation in applying pragmatic and risk based thinking,

• Deliver training and act as a subject matter expert in QA related topics.

Manage advanced QA responsibilities

• Lead and approve qualification and validation activities, including equipment, utilities, facilities and software,

• Handle and oversee complex deviations, CAPA, change controls and improvement projects,

• Support quality improvements and ensure that decisions and processes follow solid quality principles.

Additional advantage

• Experience as Lead Auditor

You are,

A senior QA professional

• With 7 to 10 or more years of experience within QA in GMP environments and ISO 13485 environments

• Confident in leading discussions, influencing stakeholders and making decisions.

Pragmatic and efficient

• Focused on what matters and skilled at removing unnecessary complexity,

• Quick in prioritisation and structured in execution.

Improvement minded

• Experienced in LEAN, continuous improvement or process optimisation,

• Able to identify opportunities to simplify, standardise and enhance processes.

A strong communicator and coach

• Able to guide others, build trust and promote strong QA practices,

• Collaborative and comfortable working independently across multiple sites.

Qualifications

• University degree in Life Science, Engineering, Pharmacy or similar,

• Strong understanding of quality principles and validation practices,

• Fluent in Danish and English, spoken and written.

We offer

·         • A central role in a company with high ambitions

·         • Opportunity to influence quality work and develop processes

·         • A strong professional environment with committed colleagues

·         • Good development opportunities and attractive employment conditions

Besides competence we are a value driven organisation, and you need to share our ambition to work to make an IMPACT for patients. We know we can make a difference by setting our mind to being Innovative - Motivated - Positive - Accountable- Customer focused and work as a Team. The position is based at our office in Køge and is a full-time position.

Interested? Send your application and CV as soon as possible, but no later than 27/2. We hold interviews on an ongoing basis and hire when we have found the right candidate.

If you have any questions regarding the role and QA, please reach out to our Group Director of QA and RA Jenny Ekberg; jenny.ekberg@maglegroup.com

If you have any HR related questions, please reach out to our Payroll Manager Kristine Garcia Castillo Samonte; kristine.garcia@maglegroup.com