Principal Quality Assurance Professional – Combination Products

Do you have proficiency in quality assurance of Medical Device and Combination Products from a GMP and regulatory requirements perspective? Are you an impactful communicator with developed stakeholder management skills?
The position
You will as Principal QA Professional be part of Global Quality and join a team of skilled colleagues.

Your main task will be to provide support and be directly responsible for a range of quality assurance functions related to medical devices, and you will contribute to ensure that development and maintenance of Medical Device and Combination Products conforms to established regulation and internal ALK requirements. You will also demonstrate a high level of involvement in continuous improvement of the quality assurance philosophy and practice to ensure the right standards are implemented.

Your primary tasks will be:

• Quality and compliance support to Medical Device and Combination Products.
• Review and approve of component related documentation: drawings and quality control specifications for medical device and combination products.
• Review and approve of measurement and validation reports for component tools used for medical device and combination products.
• Review and approve of documentation related to Design Control for Medical Device and Combination products.
• Monitor quality and compliance performance of Global Device Development department.
• Provides on-site guidance in the preparation of procedures and working instructions.
• Assists in providing resolution to quality issues through identification of problem areas, refinement of systems, training and coaching of relevant personnel.
• Helps support a permanent inspection readiness status.
• Provide QA support for regulatory filings and in relation to supplier management activities.
• Provide quality expertise, advice and/or assistance across the organisation as required.
• Perform external quality and vendor qualification audits, risk assessments and write audit reports, and follow up on observation close-outs.
• Provide quality support to technology transfer projects associated with devices.

Your profile
We expect that you have knowledge, skills and experience gained in the pharmaceutical industry. Therefore, we expect that you bring:

• Minimum of 5 years’ experience in the pharmaceutical/biotech industry with a thorough knowledge of Medical Device and Combination Products, GMP and regulatory requirements including FDA.
• Master’s degree in natural sciences, pharmacy or equivalent.
• Experience with ISO 13485 and ISO 19011.
• Expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, sterile operations, cGMP, regulatory issues, and data integrity regulation.
• Strong interpersonal and leadership skills in dealing with a variety of cultures on non-routine matters, and in stressful situations be able to handle organisational complexity and ambiguity.
• Developed communication skills in both written and spoken English.

Become a part of ALK
We provide an attractive working environment for individuals looking for both personal and professional development. ALK is a global pharmaceutical company specialised in allergy immunotherapy. We are driven by a high level of professionalism, integrity, an openminded approach and contributing to an inspiring and fun working environment together with our colleagues. You will be part of an engaged and informal team who values skill and knowledge creation.

Our offices in Denmark offer a green view of the DTU Science Park in Hørsholm. We believe that physical presence enforces strong teamwork and collaboration and creates success, so it is important that you enjoy coming to work at our site with a degree of flexibility to also work from home.

Do you want to learn more about our company, we encourage you to visit us at www.alk.net.

Apply
Apply by attaching your CV and a short letter of motivation, no later than 12 July 2024.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We evaluate applications and call for interviews on an ongoing basis, so don't wait to apply! We reserve the right to take down the advert when we have found the right candidate.

For further information regarding the position please contact Senior Director, QA Spain, Jose Luis Garcia on +34 673 98 90 26 (Mobile).

We are looking forward to hearing from you!