Senior Director, Qualified Person, Quality Assurance (QA), Anonymous at Brinch & Partners

Nykøbing Sjælland, Region Zealand, Denmark -

Full Time

Start Date

Immediate

Expiry Date

08 Jun, 26

Salary

0.0

Posted On

10 Mar, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Leadership, Qualified Person, Quality Assurance, GMP Compliance, Regulatory Affairs, Stakeholder Management, CMC Development, Product Supply, Performance Management, KPIs, Process Improvement, Strategic Thinking, Problem Solving, English Proficiency, Team Leadership, Quality Systems

Industry

Staffing and Recruiting

Description

Senior Director, Qualified Person, Quality Assurance (QA) – north of Copenhagen Do you bring strong leadership experience from a global pharmaceutical organisation and thrive in cross-functional collaboration with international stakeholders? A global pharmaceutical company is seeking a Senior Director, Qualified Person, QA for Site and CMC Development to join its Global Quality organisation. The position As Senior Director, Qualified Person, QA, you will lead a team of 40 skilled and motivated employees in Denmark and be part of a global leadership team reporting to the SVP Global Quality. You will act as the Qualified Person on the Manufacturing and Importation Authorization with the Danish Medicines Agency, supported by Delegated Qualified Persons within your team. The role plays a key part in supporting Product Supply, CMC Development and Clinical Trial Supply, while ensuring strong collaboration across the site, global functions, and external authorities. Key responsibilities · Lead and develop a high-performing QA team with strong engagement and learning culture · Maintain and develop QA oversight at the Hørsholm site · Ensure regulatory and GMP compliance (EU/FDA) and maintain “license to operate” · Strengthen quality standards, performance, and compliance across the organisation · Support cross-functional collaboration with Product Supply and CMC Development leadership · Drive improvements in quality systems, business processes and operational efficiency · Ensure scalable processes supporting development and supply activities · Promote a strong quality mindset and culture of continuous improvement · Implement process improvements to enhance service, efficiency and cost awareness Your profile You have 10+ years of experience in the global pharmaceutical industry, within quality, manufacturing, product development and/or regulatory affairs, combined with proven leadership experience. You hold a relevant university degree (minimum four years) within pharmacy, medicine, veterinary science, pharmaceutical chemistry/technology, chemistry or biology. In addition, you bring: · Strong understanding of pharmaceutical business and GMP/regulatory requirements · Experience working with authorities and strategic stakeholders · Experience with performance management and KPIs · Excellent collaboration and stakeholder management skills · Strategic mindset and strong organisational and problem-solving abilities · Professional proficiency in English, written and spoken The organisation You will join a global pharmaceutical company with a strong focus on quality, collaboration and professional development. The working environment is international and collaborative, offering a flexible workplace and opportunities for both professional and personal development. Contact and application We have partnered up with Brinch & Partners to fill this position. If you need further information about the position, please contact Partner, Jens Chr. Jensen on +45 2784 7405 or by email: jc@brinchpartners.dk. In order to apply for the job, use the “Apply for the job” option. We look forward to receiving your application and CV as soon as possible. We look forward to hearing from you.

Responsibilities

The Senior Director will lead a team of 40 employees in Denmark, acting as the Qualified Person for the Manufacturing and Importation Authorization with the Danish Medicines Agency. Key duties involve maintaining regulatory compliance, strengthening quality standards, and supporting Product Supply and CMC Development.