RTP North Carolina or remote
Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic for the acute treatment of migraine. Our lead drug candidate, STS101, is a drug-device combination of a proprietary dry-powder formulation of dihydroergotamine mesylate, or DHE, capable of being quickly and easily self-administered by a proprietary pre-filled, single-use, nasal delivery device. STS101 is currently in Phase 3 development.
This is a senior level position that is responsible for the quality oversight of design control and risk management activities for drug/device combination products.
This individual will work closely with the device development team, CMC team, and medical device suppliers and testing partners during the device design/development phases and include supportive responsibilities throughout the device lifecycle.
In addition, this role will provide oversight for the development, implementation, and continuous improvement of device-related quality processes and procedures and ensure compliance to the relevant standards and regulatory requirements for devices and combination products.
Duties and Responsibilities:
- Lead Quality Engineering guidance and oversight for medical device and combination products during feasibility, all phases of design control, risk management, human factor/usability engineering, process development and verification/validation testing, as well as lifecycle management during design changes.
- Lead device development team to define critical to quality characteristics for device components and finished devices.
- Lead Quality review and approval of all technical documentation for design and development technical and risk management documentation, e.g., planning, traceability matrix, protocols, reports, risk assessments, testing, etc. by applying applicable company procedures, standards, and regulatory requirements.
- Support IND, NDA, and post-Approval changes through authoring and/or reviewing sections of filing applicable to design control, risk management and specification and supporting responses to regulatory questions.
- Support the timely handling of investigations, impact assessment, deviations, and CAPAs.
- Function as the Quality representative on cross-function initiatives and device development programs.
- Manage QA interface with medical device or device component suppliers and testing partner by providing technical and quality support during the development, testing and manufacture at a supplier site.
- Prepare and manage development quality agreements. Support internal and external audits and inspections as a device or combination product Subject Matter Expert.
Minimum Requirements Education/Experience:
- BS degree in engineering, or similar field.
- Minimum of 7 years’ relevant industry experience.
- Experience in project execution and program management.
- Experience in Drug/Device Combination product development in a GMP setting, from early-stage development to commercial manufacture.
- Track record of developing and working with external partners.
- Strong analytical problem-solving skills a must.
- Excellent communication skills, with an ability to work in cross-functional teams including across multiple sites.
- Must be self-motivated have ability to work on own initiative.
- Strong quality orientation with attention to detail.
- Ability to identify problems and to be innovative and effective in developing solutions, mitigating execution risk.
- Collaborative leader with ability to strongly influence with or without authority, facilitate groups with diverse perspectives, and bring teams to consensus/alignment.
- High tolerance for ambiguity and change – able to create order from chaos.
- Takes accountability for actions, drives results, learns from mistakes; is direct and truthful and therefore widely trusted – delivers on promises, goals, and expectations.
- Makes quality decisions and resolves problems rapidly.
- Ability to communicate effectively at all levels of the organization.
- Excellent planning and prioritization, with an ability to multitask and adapt – able to synthesize large amount of information and deliver results despite a shifting environment.
For additional information:
Please send your resume or CV to us at firstname.lastname@example.org