Oncology, Head of Quality, Biotech, Management

Europa
About the Company: A Danish biotech company headquartered in Copenhagen, dedicated tor cancer treatment. Following significant investment rounds, the company has built an international and highly experienced management team and is progressing towards becoming a clinical-stage biotech within the next year. The company will have 4 Phase I trials within 3 years, currently there are none.

Open Position Summary: The company is seeking to hire a Strategic and hands-on Head of Quality to spearhead its Quality strategy within the GCP and GMP, including non-clinical, clinical, and CMC activities.

As Head of QA, your responsibilities will encompass:

• Leading the continued development of the Quality Management System in close collaboration with key stakeholders and ensuring interdisciplinary quality strategy alignment.

• Ensuring appropriate Supplier Management within the GCP/GMP area.

• Planning, coordinating, and conducting audits of service providers within the GCP, GLP, and GMP areas and participating in external and internal audits. Providing assistance to internal or external auditors in compliance reviews.

• Participating in the development of departmental standard operating procedures, work instructions, forms, and templates, as required.

• Ensuring the preparation and maintenance of documentation such as policies, procedures, specifications, instructions, and master files.

• Handling Deviations, CAPAs, and Change Control in compliance with SOPs and applicable regulatory requirements. Overall responsibility for complaints and recalls.

• Informing management about the effectiveness and progress of QA’s quality projects and preparing management reports regarding compliance operations and progress.

• Advising internal management or business partners on the implementation or operation of compliance programs.

• Maintaining training programs for stakeholders in relevant GXP topics.

• Accomplishing quality assurance objectives by monitoring, reviewing, preparing, and enforcing policies and procedures.

Qualifications: The ideal candidate will have substantial experience in a similar role and a thorough understanding of quality management in the biotech industry.

• Minimum of 10 years of experience in the pharmaceutical, biotechnology, or related healthcare industry in a relevant QA role.

• At least 2 years of experience in a QA role covering GCP, GMP.

• MSc degree or equivalent in a relevant life science subject.

• In-depth knowledge of International Standards, GLP, GCP, and GMP.

• Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective action plans that mitigate risks to the company, safety, and data integrity.

• Collaborative team player with a positive attitude and ability to quickly identify creative solutions to complex problems.

• Experience with health authority inspections and inspection readiness activities preferred.

• Strong personal leadership with demonstrated competency interfacing with senior leaders.

• Strong organizational skills, with the ability to effectively prioritize and manage multiple projects and tasks with attention to detail.

• Willingness and ability to collaborate with and influence other groups in a positive, team-based environment, while also being able to hold others accountable as required.

• Flexibility and adaptability to company growth and evolving responsibilities.

Contact
If you want to hear more about this opportunity and the company, or if you have any questions regarding the position, please do not hesitate to contact us. If you wish to apply for the position, please send an updated version of your CV, together with what questions you might have, and we will get in touch with you soon.

Per Christensen
Managing Director & Co-Founder
SENIOR MANAGEMENT​
[email protected]