Senior Director Quality Assurance
- Employer
- Denovo Biopharma LLC
- Location
- 10240 Science Center Drive, San Diego, California
- Start date
- Jan 25, 2019
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- Discipline
- Quality, Quality Assurance, Quality Control
- Required Education
- Bachelors Degree
- Position Type
- Full time
SUMMARY
The individual in this role will be accountable for establishing and managing Quality Management System (QMS) operations related to the company’s products, which include but are not limited to pharmaceuticals and serum-based tests/diagnostics. Provide management with reliable solutions to quality management challenges, while ensuring overall compliance with Local, State, Federal, and International regulations and standards associated with GXP’s and Quality Systems.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following: Other duties may be assigned.
- Serve as an experienced resource regarding GXP regulatory compliance (QA) issues for the company
- Establish and manage the Quality Management System (QMS)
- Develop and write the SOPs that are intended to support the QMS
- Conduct or lead the GXP audits and inspections as described in the QMS
- Effectively communicate audit findings and relevant trends to relevant stakeholders and corporate management
- Establish a system for, and manage, controlled GXP documents
- Manage the QA review and approval of GXP documents
- Hire and manage QMS personnel
- Develop effective partnerships with internal staff and external organizations to help formulate and implement proactive regulatory compliance strategies and controls
- Manage the tracking, and evaluation of trend analysis quality data and review detailed reports to corporate management. Oversee the quarterly management review meetings.
EDUCATION and/or EXPERIENCE
Position generally requires a Bachelor or Master's degree in a scientific discipline with 10 years relevant industry experience. A minimum of 4 years of interacting directly with regulatory authorities and at least 8 years supervisory/managerial experience is required. In-depth working knowledge of domestic and international regulatory requirements/regulations/guidance for the pharmaceutical industry is required. Working knowledge of serum blood testing or diagnostic product development is a plus. Experience with International Standards Organization (ISO) standards is a plus.
To be successful in this role, strong leadership and project management skills are required. Demonstrated collaboration, negotiation and conflict resolution skills are required. Computer skills competency including Excel, Word and PowerPoint programs is necessary. Proven progressive track record of managing complex quality organizations. Proven track record of successfully managing escalated compliance events (e.g., enforcement actions, recalls, etc.).
CERTIFICATES, LICENSES, REGISTRATIONS
None required; however, Regulatory Affairs Certification (RAC), ASQ certification(s), or Six-Sigma training/qualification is preferred.
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