Quality Director
Charleston, SC
Hybrid
An innovative manufacturing organization, specializing in affordable reproductive health products, is actively pursuing a Quality Director with strong leadership abilities and a proven track record of excellence, to come in and provide direction and management over all Quality operations.
Summary:
The Quality Director will lead the internal Quality team and build relationships with key internal department leaders and external consultants as necessary to support QA activities, responsibilities, and provide leadership & guidance on quality matters. This role is accountable for ensuring that sites and vendors are compliant with global regulations, prepared for potential health authority Audits and Regulatory Inspections and that the appropriate processes, systems, and activities are in place and performed to protect patient safety, product quality, and data integrity. The successful candidate will drive, promote, and embed a culture of ethics, integrity and continuous improvement that will focus on delivering efficiency.
Responsibilities:
- Lead a team that provides Quality Assurance oversight of GMP and GCP activities for the company and its suppliers.
- Develop and implement risk-based Quality strategies for investigational and commercial materials, including establishment and maintenance of phase-appropriate quality systems; proactively identify and mitigate quality risks.
- Responsible for Manufacturing, Clinical and Nonclinical quality-related activities, and optimize the quality management system; overseeing vendor, internal, and site audits; supporting teams during health authority inspections; and providing guidance on quality issues.
- Ensures quality metrics comply with best industry standards and practices.
- Lead Quality investigations, including input and approval of plans for resolution of product-impacting Quality issues; provide oversight of appropriate CAPAs associated with deviations and investigations.
- Ensure TD&O and GCP vendor activities are compliant with cGMP, FDA, ICH regulations and guidelines and industry standards.
This is clearly a very EXCITING opportunity! Don't miss your chance, apply TODAY!