Delpor is a clinical stage life sciences company that utilizes innovative drug-delivery technologies in order to develop once-yearly therapies for chronic conditions. The Company’s lead product is a 6-12-month formulation of Risperidone (drug/device combination product) for the treatment of schizophrenia. Delpor is also pursuing 6-12 month formulations of other drugs targeting CNS conditions including Neuromuscular Diseases, Neurodegenerative Diseases, Addiction, and other disorders.
The Company’s lead product has recently completed a Phase 1 clinical study and is expected to advance to phase 3 next year. As a result, we are in the process of enhancing our team. This is a great opportunity for someone interested in professional growth. The selected candidate will become a key member of our team, join a life sciences company with groundbreaking technology at the time of its growth spurt, and make vital contributions in bringing cutting edge products to market that can benefit millions of patients.
The Director of Quality Assurance & Regulatory Affairs will be responsible for QA, safety, and regulatory compliance while identifying continuous improvements. He/She will be responsible for the development and implementation of QA policies and assure the structure, systems and processes are in place to enable ongoing success. The role will be responsible for working with outside regulatory consultants in creating all deliverables respective of FDA regulatory requirements.
- Develop and Implement Delpor’s Quality Management System and controls to constantly monitor and ensure the quality, safety, regulatory compliance, and continuous improvement.
- Work with the Company’s regulatory consultants to communicate with the FDA and ensure compliance with all applicable regulatory guidelines and Agency statutes.
- Communicate with in house employees and external vendors/consultants to build, enhance, and ensure quality awareness and regulatory compliance.
- Monitor required processes to ensure that quality standards are implemented.
- Ensure the proper interface of the quality function to product development, manufacturing, supply chain, and other areas as required.
- Oversee regulatory filings for combination drug-medical device products
Required Skills & Experience
- Bachelor’s degree – Master’s degree a plus but not required.
- 5+ years of progressive quality and regulatory affairs experience in an FDA regulated drug and/or medical device environment including some experience with combination products.
- Experience with Combination Products is strongly preferred and a big plus
- Track record of success, and a broad understanding of current QA practices as they apply to product development, manufacturing and commercial operations in an FDA regulated and ISO certified environment.
- Advanced understanding of QA and Regulatory Affairs requirements, specifically knowledge of current FDA guidelines (experience with other Agencies a plus)
- Experience applying Quality risk management for medical device and/or drug product development and manufacturing.
- Experience with all phases of the product development lifecycle, including concept, design, implementation, verification and validation activities necessary for product commercialization.
- Experience in GMP and other Regulatory compliance requirements.
- Experienced in regulatory filings for US (EU and other key countries/regions a plus).
- Excellent written and verbal communication skills.
- Able to balance QA responsibilities while working in a startup (i.e., less structured) environment
If you meet the requirements above, please email a copy of your resume and cover letter to: firstname.lastname@example.org
Delpor is a clinical stage life sciences company that utilizes innovative drug delivery technologies in order to develop once-yearly therapies for chronic conditions. The Company’s lead product is a 6-12-month formulation of Risperidone for the treatment of schizophrenia (drug/device combination product). Delpor is also pursuing 6-12 month formulations of other drugs targeting CNS conditions including Neuromuscular Diseases, Neurodegenerative Diseases, Addiction, and other conditions. Additional information may be found at the Company’s website (www.delpor.com) or at the following video: https://vimeo.com/248887879
Compensation and Benefits
Competitive salary based on experience, plus equity package (stock options) and benefits including paid vacation, medical, and dental.