Aruna Bio is advancing a new class of cell-free biologics, exosomes, for the treatment of central nervous system (CNS) and neurodegenerative disorders and leveraging our novel platform to optimize the delivery of RNAs, antibodies, genes, and small molecules. Through this platform and our partners, we strive to improve outcomes for CNS cancers, neurodegenerative, genetic, and rare diseases.
Aruna Bio currently offers a wide range of full-time employee benefits that include:
• Medical/Dental/Vision insurance options
• Generous Paid Time Off
• Generous Holiday calendar
• Employee retirement plan
• Employee training and professional development opportunities
If you are energetic, highly motivated and want to work in a fast paced, team-focused environment, then Aruna Bio wants to hear from you. The company is currently seeking to fill the following position.
Position Description – Director of Quality
We are seeking a talented, highly motivated and experienced Quality professional. The Director of Quality will be responsible for the development, implementation and maintenance of the company’s quality systems and activities, and for building out the Quality group as the company develops and expands. Reporting to the VP of Quality and Regulatory Affairs, this position will have accountability for assuring that the company operates in GxP compliance (with heavy focus on GMP activities). Ideal candidates will be located in RTP, NC or Athens, GA; remote positions must be able to travel up to 50% of the time (domestic).
• Responsible for development of Quality systems in support of GMP, GDP, GCP and GLP.
• Responsible for Quality oversight for development of drug candidates at various stages in the product pipeline, including clinical development through to market approval and ensure concordance with appropriate regulations.
• Maintain Quality expertise and serve as internal consultant on Quality compliance matters and relevant standards (e.g., FDA regulations, ICH guidelines, cGMP regulations).
• Ensure effective Quality systems and procedures, including creating and reviewing SOPs as needed.
• Review and approval of GxP documentation, including but not limited to batch records, qualification/validation documentation, SOPs, specifications.
• Review and approval of deviations, investigations, CAPAs and change controls.
• Responsible for lot release and disposition.
• Work closely with external consultants and partners.
• Serve as primary Quality representative for cross-functional teams.
• Plan, manage and execute Quality activities, including internal audits, Quality risk management and Quality metrics.
• Serve as primary liaison with regulatory authority inspections, and ensuring appropriate follow-up.
• Participate in CRO/CMO/vendor selection and qualification process, including auditing of vendors and implementation of quality agreements as needed.
• Other duties, as assigned.
• An advanced life science degree (MS, Ph.D.) is preferred with 8 + years of quality experience, including 5 + years management experience, preferred.
• Experience contributing to the development of Quality systems, procedures and standards.
• Experience working in a small company and working with biologics is highly desirable.
• Solid working knowledge of drug development process and GxP requirements.
• Knowledge of domestic and international regulations and guidelines regarding drug development.
• Proven ability to lead collaborative teams as well as effectively collaborate cross-functionally, across all levels of the organization.
• Problem solver with strong strategic and analytical abilities.
• Effective management and negotiation skills.
• Diplomatic individual with excellent written and oral communication skills with strict attention to detail.
• Proven ability to multi-task and meet multiple high priority deadlines.
• Ability to think and work independently with limited supervision while demonstrating personal accountability.
Qualified candidates submit cover letter and resume to: firstname.lastname@example.org Subject line: Director of Quality