Position Summary
The GxP Auditor supports the Company's oncology programs by performing external risk-based audits of contract manufacturing organizations (CMOs), contract research organizations (CROs), vendors, clinical sites, and suppliers. The GxP Auditor is responsible for vendor oversight and assurance of day-to-day compliance, including quality event management and escalation. This position also plays a critical role in the Company's inspection readiness efforts by completing high quality, comprehensive, complete, and accurate reviews and subsequent remediation activities as needed ensuring contemporaneousness.
This position is remote with a corporate headquarters in Foster City, CA and Parsippany, NJ. The GxP Auditor will report to the Director, Clinical Quality Assurance.
Primary Responsibilities
- Support and manage the planning and maintenance of annual audit program schedule, including coordinating audits as assigned
- Lead, perform, and report audits to address qualification, routine, or suspected critical issues at CMOs, CROs, vendors, suppliers, and clinical sites, ensuring vendors have quality and production systems that meet applicable regulatory, GxP, and Company SOPs
- Write and issue audit reports in accordance with Company SOPs, templates, and timelines ensuring clear communication of audit findings to the relevant project team members
- Assess auditee's capabilities, technology, data integrity practices, and regulatory compliance practices and recommend necessary changes to ensure adherence to standards when non-compliance is identified
- Evaluate finding responses, track deliverables, and follow up on actions to closure (i.e., Corrective and Preventive Actions (CAPAs), Effectiveness Checks (ECs)) to ensure timely completion, effectiveness, and quality.
- Support serious breaches investigations, and help oversee the project team reach a final decision regarding the reportability of a critical quality event
- Active involvement in the organization of appropriate support for the preparation, conduct, and follow-up of global quality audits of vendors impacting good pharmacovigilance practices (GVP)
- Optimize new and existing SOPs to maintain and improve quality standards
- Perform other quality related tasks or initiatives, as assigned
Competencies
- Current and strong working knowledge, interpretation, and implementation of United States FDA Regulations, ICH Guidelines, and other local government regulatory requirements governing biopharmaceutical research
- Extensive knowledge and application of ALCOA+ standard, GxP, and global guidelines
- Ability to interpret and apply regulations, regulatory guidance, and identify and recommend compliance changes as appropriate
- Highly diplomatic and tactful individual with exceptional critical reasoning skills
- Well-organized and detailed oriented professional with excellent verbal and written communication skills
- Self-motivated with the ability to function independently and within a team in a fast-paced environment
- Flexible attitude to work assignments and new learning and the ability to adjust to changing priorities and unforeseen events
- Ability to follow up on multiple tasks simultaneously
Experience
- Bachelor's degree in science/technical field (e.g., biochemistry, bioengineering, clinical research, etc.), or equivalent combined education and experience; Master's degree a plus
- At least 5 years of experience in a quality/compliance-based role with relevant audit management/execution and inspection readiness experience
- Experience working in small to mid-size pre-IND to commercial organization a plus
- Extensive experience in GxP auditing covering GMP, GVP, and GLP functions; GCP experience a plus
- Auditor experience required, certifications a plus
EEO Statement:
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Benefit Statement:
All regular-status, full-time employees of Geron are eligible to participate in the Company's comprehensive benefit program, pursuant to plan terms and conditions. Plan choices include medical, dental, vision, life insurance, flexible spending accounts, disability insurance, supplemental health insurance, a 401(k) retirement savings plan, and an employee stock purchase plan. Geron also provides regular-status, full-time employees with a generous time off program that includes the eligibility to accrue 160 hours of vacation during each full year of employment, 64 hours of sick leave, 9 standard paid holiday days off, and paid leave for certain life events. Geron recognizes that its employees work in many different states and therefore may be affected by different laws. It is Geron's intention to comply with all applicable federal, state, and local laws that apply to the Company's employees.
Salary Statement:
Offered compensation is determined based on market data, internal equity, and an applicant's relevant skills, experience, and educational background. The salary ranges displayed below are only for those who, if selected for the role, will perform work in the specific locations listed. Please note the employment opportunity is not limited to these locations.
General Salary Range: $95,000 to $110,000