RTP North Carolina
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 being evaluated in a Phase 3 clinical trial.
Reporting to the Vice President of Regulatory Affairs and Quality, the Associate Director or Director of Quality Assurance and Compliance is responsible for supporting the quality system processes and for maintaining quality assurance standards, processes, and controls. The position will provide compliance leadership and work with internal project teams and external vendors and auditors to maintain integrity and high standards in meeting operational objectives.
Duties and responsibilities:
- Lead a Quality Management System and GCP and GMP compliance strategy for internal activities and at contract service providers
- Develop and maintain GCP and GMP related quality system SOPs, in compliance with all applicable regulatory requirements and as appropriate for the company’s current needs
- Provide Quality oversight of external vendors’ quality programs, including negotiating and maintenance of quality agreements and vendor compliance
- Ensure clinical trials, preclinical/nonclinical studies and manufacturing campaigns are performed in accordance with applicable protocols and in compliance with applicable regulatory requirements
- Evaluate quality events/incidents/issues and perform risk analysis, identify remediation actions and communicate to management or other stakeholders, as appropriate
- Develop and execute an audit strategy for external quality audits of clinical sites, clinical and preclinical vendors, CMOs and other manufacturing vendors
- Manage/conduct internal audits to ensure compliance with policies, procedures, GxP requirements and guidelines
- Lead GCP/GMP training of functional areas
- Provide expert GxP advice to internal stakeholders
- Monitor and analyze quality trends, identify continual improvement opportunities and conduct training as needed.
- Represent Quality in project team meetings
- Manage regulatory authority inspections and coordination of responses to inspection findings, if any
Behaviors / skills:
- Ability to effectively collaborate across all functions of the business so as to ensure consistent and timely achievement of program deliverables.
- Excellent written and oral communication skills, with an ability to work in cross-functional teams including across multiple sites.
- Skilled at providing cross-functional training on GXP requirements to internal project teams
- Excellent planning and prioritization, with the ability to multitask and adapt.
- Self-motivated, with the ability to plan own work.
- Strong quality orientation with keen attention to detail.
- Makes quality decisions and resolves problems rapidly.
- Ability to travel required.
Education & experience:
- Bachelor’s degree in a scientific discipline.
- Minimum of 8 years experience in pharmaceutical industry with a minimum of 5 years of GCP or GMP compliance.
- Experience with Quality Management Systems required.
- Experience overseeing risk assessments for drug-device combination products highly desired.
- Experience in both GCP and GMP oversight is preferred.
For additional information:
Please send your resume or CV to us at email@example.com