Skills

Communication Time Management Quality Assurance Quality Management Attention to detail Training Organization

Job Specifications

About the Company:

We are a dynamic, early-stage biotherapeutics company backed by leading life science investors. Our mission is to improve human health through the development of innovative neuroprotective therapies. By combining cutting-edge science with a patient-centric approach, we are advancing novel small molecule and gene therapy solutions for prevalent, vision-threatening diseases that currently lack effective treatment options.

Position Summary:

We are seeking a Quality Systems Specialist to support the development and continuous improvement of our Quality Management System (QMS). This role is ideal for a proactive, detail-oriented individual who thrives in a fast-paced, collaborative environment and is passionate about advancing life-saving therapies. The role involves cross-functional collaboration to maintain compliance with global regulatory standards and ensure alignment with product development goals.

Key Responsibilities:

Contribute to the design, implementation, and maintenance of a compliant and effective Quality Management System.
Support and enhance core quality processes including Document Control, Supplier Qualification, Deviations, and Complaint Handling.
Collaborate with teams across R&D, Operations, and Regulatory to align quality initiatives with organizational priorities.
Lead or support quality investigations, including root cause analysis and implementation of corrective and preventive actions (CAPA).
Assist in developing and delivering internal training on QMS processes, regulatory expectations, and quality standards.
Review and approve controlled documentation such as standard operating procedures (SOPs), technical records, and quality reports.
Support regulatory submissions by ensuring completeness, accuracy, and compliance of relevant quality documentation.

Qualifications:

Bachelor's degree in Life Sciences or a related field.
Minimum 5 years of experience in Quality Systems or Quality Assurance within biotech, pharmaceutical, or medical device industries.
Strong working knowledge of regulatory requirements and guidelines (e.g., FDA, EMA, ICH, GMP).
Hands-on experience with electronic systems for document control, complaint tracking, and supplier management--especially within a virtual or distributed organization.
Demonstrated ability to conduct investigations and audits related to quality issues.
Excellent organizational and time management skills; able to balance multiple priorities effectively.
Strong written and verbal communication skills, with an emphasis on collaboration and clarity.
Proficient in MS Office and cloud-based tools (e.g., Box or equivalent platforms).
Attention to detail with a solutions-oriented mindset and a passion for continuous improvement

About the Company

We are BioTalent, the life sciences recruitment specialists with the means to nurture change-makers. Our expert consultants focus on Medical Communications, Healthcare Advertising and public Relations, Market Access, Research and development, Data Science & AI, Clinical, Regulatory, Engineering & CQV, Manufacturing & Operation, Quality, Medical and Drug Safety, and Commercial. We have a global reach, with offices in the UK (London), Switzerland (Zug), and the USA (New York, San Diego, Miami and Boston). We are part of T... Know more