Manager / Associate Director of Quality, External Manufacturing & Clinical Product Release

Scorpion Therapeutics; United States; Remote; USD 100,000 - 150,000; Full time

Job summary

Join a clinical-stage biotech company as a Manager / Associate Director of Quality, External Manufacturing & Clinical Product Release. You will ensure compliance with regulatory requirements, maintain relationships with CMOs, and contribute to quality control systems for clinical programs. Ideal candidates will have a strong background in quality assurance and thrive in a fast-paced environment.

Qualifications

• 5+ years in quality assurance within biotech/pharmaceutical industry.
• Experience in external manufacturing oversight and product release.
• Familiarity with FDA, EMA regulations.

Responsibilities

• Implement and maintain quality systems for external manufacturing.
• Assist in developing quality agreements with CMOs.
• Execute quality oversight of CMOs and manage deviations.

Skills

Quality Management

Regulatory Compliance

Risk Management

Team Leadership

Analytical Skills

Communication

Education

Bachelor's degree in a scientific discipline

Master's or PhD preferred

Job description

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Join Hemab

Join Hemab, a clinical-stage biotech company, on an exciting journey to build the ultimate clotting company. We focus on addressing the high unmet needs of patients suffering from rare bleeding and thrombotic disorders. With offices in Copenhagen, Denmark and Cambridge, MA, USA, Hemab cultivates a vibrant, agile, and forward-thinking environment where collaboration, innovation, and high-quality biotherapeutics development go hand in hand.

Role Overview

As Manager / Associate Director of Quality, External Manufacturing & Clinical Product Release, you will be responsible for implementing quality systems that ensure our externally manufactured products meet regulatory requirements and are suitable for clinical use. You will maintain relationships with contract manufacturing organizations (CMOs), support product release activities, and contribute to quality control systems for our clinical programs. The ideal candidate will combine technical knowledge with quality management experience and thrive in a fast-paced biotechnology environment.

Reporting Structure

This role will report to the Director of Quality with the responsibility of supporting the quality and compliance of externally manufactured products intended for clinical trials. By collaborating with CMOs, internal teams, and regulatory authorities, this position will contribute to quality excellence in external manufacturing operations and help maintain a culture of compliance and continuous improvement.

Working Environment

At Hemab, we foster an environment where everyone can wear ‘multiple hats’ depending on their experience and motivation to get things done ‘right first time’. We constantly strive to celebrate our achievements collectively and gather feedback to sustain and improve our fast-paced cross-functional work environment continuously.

What you’ll Do at Hemab

• Implement and maintain quality systems for external manufacturing, ensuring compliance with GMP regulations and alignment with Hemab's quality standards.
• Assist in the development and implementation of quality agreements with CMOs that define quality expectations, responsibilities, and communication pathways.
• Execute quality oversight of CMOs, including participation in qualification, auditing, and routine monitoring activities.
• Review validation protocols, batch records, analytical methods, and specifications from CMOs.
• Follow risk-based approaches to CMO oversight that focus resources on critical quality attributes.
• Perform product release activities, including review of batch records, analytical results, and other release documentation.
• Collaborate with the Qualified Person (QP) to support timely release of investigational medicinal products (IMPs) for clinical use.
• Contribute to systems that track and trend product quality data to identify improvement opportunities.
• Manage deviations, investigations, CAPAs, and change control processes related to externally manufactured products.
• Work with manufacturing, technical operations, and clinical teams to address quality issues in a timely manner.
• Participate in cross-functional product development team meetings as a Quality representative.
• Lead efforts and over time build a small team of quality professionals focused on external manufacturing oversight and product release to meet Hemab’s evolving needs.
• Implement training activities to ensure staff are knowledgeable about GMP requirements, quality systems, and Hemab's products.
• Support regulatory inspections and contribute to the preparation of regulatory submissions.

Who You Are and What You’ll Bring to Hemab

• Bachelor's degree in a scientific discipline (e.g., biochemistry, pharmaceutical sciences, biotechnology); advanced degree (Master's or PhD) preferred.
• Minimum of 5+ years in quality assurance within the biotech or pharmaceutical industry, with at least 2 years focused on external manufacturing oversight and product release.
• Familiarity with FDA, EMA, and other global regulatory frameworks applicable to pharmaceutical manufacturing; experience working with CMOs.
• Working knowledge of QMS, GMP regulations, and validation processes for biologics and small molecule manufacturing.
• Experience with product release, including review of batch documentation, analytical data, and supporting records.
• Ability to lead and mentor a small team while managing multiple priorities in a fast-paced setting.
• Solid knowledge of GMP regulations and their application to external manufacturing operations.
• Basic technical understanding of manufacturing processes and analytical methods.
• Developing audit skills and ability to evaluate quality systems.
• Methodical approach to risk management and quality oversight.
• Effective communication skills for interacting with CMOs.
• Ability to analyze data and apply regulatory requirements to decision-making.
• Team-oriented with cross-functional collaboration skills.
• Must demonstrate clear written and verbal communication skills and work well with diverse teams and stakeholders.
• Must be adaptable to shifting priorities and timelines through problem-solving capabilities to meet deadlines and contribute to multiple projects.
• Self-motivated with a strong team orientation.