DIRECTOR OF QUALITY ASSURANCE
CVforum is looking for a Director of Quality Assurance (QA) for a client in the chemical industry
The client recently joined a US company to form and develop a world leading biomaterials focused company. The client located north og Copenhagen is actually employing eighteen highly motivated and skilled specialists.
The company is specialized in the manufacturing of chemical materials for the medical devices and pharmaceutical industries. The organization presents an exciting employment opportunity within a dynamic and growth-focused environment.
Marked by an informal, family-like atmosphere underscored by a high level of professionalism, the company is committed to guiding the clients through the complete process from development to the final production of tailor-made polymers for medical devices and pharmaceutical products.
THE JOB
As Director of QA, you will be a driving force in ensuring compliance with industry standards and regulatory regulations.
In close corporation with the USA part of QA & Regulatory affairs (RA), you’ll be driving the process of establishing the ISO13485 system. You'll play an integral part in developing the QA team, contributing to the leadership and management team.
You’ll be reporting to the Danish Managing Director and will be a part of the company wide QA & RA team. At the same time there will be a dotted line to the QA director in USA.
Key responsibilities include:
- Management Representative with overall responsibility for the entire organization’s development, implementation, and maintenance of quality systems to assure EU/FDA and ISO compliance
- Provide hands-on leadership and guidance in the execution of all quality system activities
- Gaining and maintaining knowledge on new/updated regulations and guidelines
- Assist the development of the overall quality excellence
- Reviewing and authoring QMS SOPs, work Instructions, and other necessary documents
- Assuring product release and conducting batch reviews, occasionally hands-on as needed
- Supporting the transfer of customer-based R&D projects into the production
- Facilitating Quality Management Reviews, KPI analysis, and other quality-related reporting
- Leading all customer quality audits and ISO/regulatory audits
QUALIFICATIONS
You have a relevant scientific background as MSc degree within Chemical Engineering, Biochemistry or similar supplemented with minimum 5 years of QA experience in a regulated life science industry e.g., Medical Device, Pharmaceuticals.
To this follows at least 3-5 years in a supervisory/management position and in-depth knowledge and application of ISO13485, or GMP under 21 CFR Part 820 and/or EU MDR supplemented with minimum 5 years of experience with outsourced manufacturing or CMO production.
Additional requirements
- Lead auditor, risk assessment, or design control experience
- Excellent interpersonal, problem-solving and Danish communication skills besides fluent in English
- Collaborative mindset, adaptable to a dynamic and evolving environment
As a person you are committed to maintaining elevated quality standards, ensuring precision and excellence in all tasks and proficient in data-driven problem-solving, utilizing analytical insights to drive effective and informed decision-making.
Furthermore, you are not afraid to engage with the unknown and be innovative, take lead on the tasks and drive the development projects.
TERMS OF EMPLOYMENT
You will be employed on white-collar terms with a salary that fully matches your qualifications. This includes pension and health insurance.
For further information please contact Morten Otto at CVforum on Cell phone 25700272
APPLY FOR THE JOB
Send your application ASAP to job@cvforum.dk and we will get back with more information.
Application deadline 10th of April 2024
