Associate Director/director, Quality Assurance
4 days ago
**JOB DESCRIPTION**
**ROLE**: Associate Director/Director, Quality Assurance (QA)
**REPORTING TO**:Managing Director
**DEPARTMENT**:Quality
**ABOUT ARIBIO**:AriBio is a rapidly growing clinical stage biotech firm dedicated to developing treatments for neurodegenerative diseases, including Alzheimer’s disease. Our commitment to innovative, polypharmacological approaches targets the complex pathophysiology of these diseases. We are in the midst of a global Phase 3 program for Alzheimer’s disease and are advancing multiple earlier-stage compounds. We seek a motivated and experienced professional who shares our passion for making a meaningful impact on patient lives in a dynamic environment.
**JOB SUMMARY**:The Associate Director/Director, QA is responsible for developing, implementing, monitoring, and overseeing GxP Quality Systems and Practices for AriBio. This role will ensure quality and compliance of AriBio’s development programs with respect to QMS management, controlled documents, eTMF and applicable regulatory requirements
**ESSENTIAL DUTIES & RESPONSIBILITIES**
- Builds and leads the quality function focusing on quality and compliance management in US and international operations.
- Establishes quality standards, guidelines, policies and documentation.
- Manages AriBio’s quality and compliance with an aim to address the growing pipeline and operations by providing pragmatic approaches to address risk and enable sustained compliance within all GxP areas.
- Responsible for implementation, realization, and maintenance of the Quality Management System (QMS).
- Handle deviations, quality issues, CAPAs, and changes as required.
- Implements inspection readiness program and provides leadership for inspection readiness training and preparation for inspections of investigator sites, external manufacturing operations, testing operations, and logistics.
- Acts as the quality primary point of contact for regulatory agencies and leads GxP health authority audits and inspections.
- Accountable for quality oversight of all clinical and non-clinical studies.
- Advises executive team on the implications and risks related to key quality issues and important strategic decisions, keeping stakeholders posted, on a timely basis.
- Works closely with GxP functions on regulatory compliance (including support and execution of health authority audits, and inspections).
- Provides appropriate quality oversight of external vendors (CRO, CMO, etc.)
- Other duties as assigned.
**MINIMUM EXPERIENCE, EDUCATION, CERTIFICATIONS, LICENSES**
- Bachelor’s degree required, in life sciences related field preferred.
- A minimum of 10 years’ experience in a Quality role in the pharmaceutical or biotechnology industry.
- A minimum of 5 years of Quality Assurance auditing experience.
- A minimum of 5 years of Quality Systems experience.
- Experience in large, global, multi-regional clinical trials.
**PREFERRED EXPERIENCE**
- Prior experience in Neurology is preferred.
- Advanced degree in a scientific field preferred.
- Experience in GLP, GVP, GCP a plus.
- Quality Assurance Professional Certification a plus.
- Vendor audits experience a plus.
**SKILLS/QUALIFICATIONS**
- Maintains expert up-to-date knowledge on legislation and GxP guidelines requirements and practices and ensure that the information is integrated into the quality and operating processes supporting clinical development.
- Ability to interpret quality standards for implementation.
- Highly self-motivated, well-organized, and detail oriented.
- Ability to develop solutions to a variety of complex problems and initiatives.
- Flexibility in problem solving and work hours to meet business objectives.
- Strong team player with a demonstrated track record of success in a cross‐functional team and fast-moving environment.
- Excellent organizational, computing, and oral/written communication skills
- Ability to influence and formulate effective solutions.
- Strong critical thinking and decision-making skills.
- Demonstrated ability to lead people in a positive manner.
- Ability to prioritize tasks and to delegate them when appropriate.
- Ability to read and comprehend policies, procedures, instructions, etc., to write reports, to use logic and data to solve problems, to assess needs, and varying degrees of independence, judgment, and discretion.
- Proficient with Microsoft Office Suite.
**SUPERVISORY RESPONSIBILITIES**
- Oversees the daily workflow of the department.
- Oversight of external vendors.
- Other related supervisory responsibilities as assigned.
**WORK LOCATION & TRAVEL REQUIREMENTS**
- This position is primarily on-site and is located in our San Diego, California office.
- Remote work is currently available one day per week and may be coordinated with your supervisor. Domestic and international travel will be required from time to time as needed (approximately 15%).
**PHYSICAL REQUIREMENTS & ENVIRONMENTAL CONDITIONS**
- The duties of this role are ge
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