Senior Specialist, Global QMS
O
Orca BioBiotechnology
Sacramento, CA / RemoteFull-TimeSenior
Salary90,000 - 120,000 USD per year
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Job Details
- Experience
- Minimum 5+ years
- Required Skills
- Quality Assurance
Requirements
- Bachelor’s degree in a scientific or engineering discipline required; advanced degree preferred.
- Minimum 5+ years of relevant Quality Assurance or Quality Systems experience in a GxP-regulated environment.
- At least 2-3 years in a leadership role.
- Strong knowledge of global quality regulations and standards (FDA, EMA, ICH, ISO 9001, 21 CFR Parts 210/211/820, EU GMP).
- Proven experience leading Quality Management Review, internal audit programs, supplier management processes, and validation oversight.
- Demonstrated success in establishing and trending quality performance metrics and KPIs.
- Experience supporting and/or administering electronic QMS systems and partnering with IT for system enhancements.
- Experience working in a multi-site or global quality organization strongly preferred.
- Excellent organizational, analytical, and communication skills, with the ability to influence and collaborate across functional and site boundaries.
Responsibilities
- Plan, schedule and execute internal audits across all sites and functions in accordance with the internal audit program.
- Develop audit agenda, conduct interviews, review processes and generate audit reports.
- Support the global Quality Management Review (QMR) process, ensuring timely data collection, analysis, and reporting to senior leadership.
- Support the supplier qualification and management program, including risk assessments, supplier audits, and ongoing monitoring to ensure compliance with GxP requirements.
- Drive global inspection management activities, ensuring cross-functional and site readiness for FDA, EMA, and other health authority inspections.
- Provide oversight and guidance to site QMR administrators ensuring consistent quality system implementation across all Orca Bio sites.
- Establish and monitor global QMS key performance indicators (KPIs), oversee trending of quality metrics, and ensure data-driven insights are used to improve quality systems and performance.
- Partner with IT and business process owners to identify and implement QMS system enhancements, including defining requirements, driving prioritization and ensuring changes are validated and compliant.
- Review, approve, and provide quality oversight for validation documentation (e.g., equipment qualification, computer system validation, process validation) for global enterprise systems ensuring alignment with regulatory and internal requirements.
- Collaborate with cross-functional and site leadership teams to drive continuous improvement initiatives, ensuring the QMS evolves in line with business needs and regulatory expectations.
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