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.