Are you curious, driven, and collaborative? Do you want to work at one of the most innovative and impactful biotech companies in the Bay Area? Mission Bio’s Tapestri Precision Genomics Platform was #2 on the TheScientist’s 2018 Top 10 Innovations list. And single-cell sequencing, which we focus on, was voted Nature Methods Method of the Year 2019. Our mission is to enable our customers to eliminate cancer.
Mission Bio is a start-up providing the best-in-class solution for single-cell genomics, ranging from research to translational/clinical medicine. We are a small team that is growing rapidly, so this is an opportunity for a talented, driven individual to significantly impact the direction and success of an exciting young company. We are committed to diversity. If you are a collaborative, curious, hardworking professional who thrives in a fast-paced, dynamic, supportive environment, we would love to meet you.
ESSENTIAL DUTIES AND RESPONSIBILITIES (Other duties may be assigned)
The ideal candidate will have extensive experience managing Quality Systems, Quality Operations, and deep understanding and demonstrated working knowledge of ISO guidance documents, and other regulations that govern GLP GMP compliance. This includes Quality oversight of computerized systems and software validation, training, product disposition, and management of CMO/CTL activities related to manufacturing and testing of consumables and instruments. ISO 13485 experience a positive.
QUALIFICATIONS, EDUCATION, AND EXPERIENCE
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below represent the knowledge, skill, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The candidate should have:
- Bachelor's degree in a scientific discipline
- 5+ years of hands-on experience in the pharmaceutical or biotechnology industry, with specific experience in Quality Assurance, CMO oversight, auditing, and Quality Systems
- Lead the effort for continuous improvement of the Quality Management System (QMS)
- Lead the Client management of Quality Management Systems (eQMS)
- Manage the maintenance of SOPs, training programs, deviations, CAPAs, commercial/investigational product complaints, vendor qualification/auditing and the documentation of these activities in the QMS
- Organize and train personnel regarding regulatory agency inspection readiness of the QMS and assist during inspections
- Develop and maintain systems for efficiently and securely storing training materials, records, and documents supporting commercial and development activities
- Assist in Quality Systems management of QA Operations, scheduling of and internal and vendor audits, and resolution of findings
- Spearhead the effort to implement internal ISO status
- Thorough understanding of quality systems that support internal activities, pre-clinical, clinical, and commercial products
- Experience with ZenQMS a plus
- Results and goals oriented with the ability to work independently with minimal guidance
- Able to work collaboratively in a matrix structure while ensuring that timelines and deliverables are met
- Excellent verbal, written, interpersonal, organizational, and communication skills are necessary with the ability to influence individual and teams across the organization in the absence of a direct reporting relationship
- Able to grasp new technologies
- Excels under deadline pressure, and can effectively prioritize and manage multiple projects (multi-task) and rapidly shifting priorities in a very fast-paced environment
While performing the duties of this job, the employee is regularly required to focusing on detailed works. The employee must occasionally lift and/or move up to 25 pounds. The employee may be required to sit or stand for extended periods.
The work environment is evolving and fast-paced