Director of Quality
Summary of Position:
Erbi is a growth-stage startup with a mission to streamline cell culture with products that simplify bio-pharma and cell therapy process development and manufacture. Our Director of Quality will have responsibility over Quality Assurance systems and compliance programs supporting global GMP activities. Successful candidates will have practical knowledge of relevant FDA and international regulatory requirements for life science instrumentation and manufacturing equipment, as well as experience working in GMP regulated environment. The individual will provide quality leadership to the overall business, including promotion of a culture of quality across the organization and successful ISO registration. Responsibilities include developing strategies, leading programs and activities to support internal and contract manufacturing across the entire product line.
Role and Responsibilities
- Implementation of appropriate TQM tools in manufacturing and across the organization (CAPA, RCCA, 8D, etc…)
- Lead efforts to establish GMP manufacture/product release
- Collaborate with Operations Manager to:
- Establish and drive a robust manufacturing/product quality program
- Manage product quality plan in place for existing products
- Design, assemble, test and vendor quality plans.
- Implement program/process to track manufacturing, failure and resolution data
- Lead efforts to establish a comprehensive quality program across the organization.
- Work with Operations, R&D and Marketing to establish objectives and deliverables
- Develop and document SOP’s for ‘vital few’ processes
- Prepare organization for successful ISO certification
- Prepare and manage quarterly business reviews, goals and organizational growth/accountability programs
- Provides strategy, operational leadership and expertise in the development, implementation, and training of cGMP systems, such as document control, change control, investigations, deviations, CAPA, and product/customer complaints
- Build overall quality organization to support growth of business
- Develop operating and capital expense budgets
- Manage regulatory inspections and client audits
- Support establishment and/or improvement of quality metrics and mitigation strategies where appropriate
- Lead development of a robust of Quality Management System
Qualifications and Education Requirements
- Bachelor’s degree in a Life Sciences discipline or equivalent.
- Minimum of 10+ years’ experience in GMP oriented environment and Quality Assurance within the biotech, pharmaceutical industry
- Minimum of 3 years’ experience leading a quality organization.
- Knowledge of bioprocess or cell therapy process development is a plus
- Significant experience in supporting functional areas (e.g. R&D, Manufacturing, QC, Engineering, EHS, Tech Services) preferred
- Validated knowledge of FDA and EMA regulatory requirements applicable to biologics or pharmaceuticals.
- Expert knowledge of GMP regulations, good documentation practices, cGMP, 21CFR, USP and other applicable regulations, standards and guidance.
- Knowledge of industry standards and regulation requirements for biologics and paternal products in clinical development and for approved commercial products.
- Excellent interpersonal skills both written and verbal communication
- Ability to multitask, strategically and tactically
- Extremely detail oriented with strong analysis skills
- Experience using Microsoft Office applications.
About the Company
Erbi Biosystems Inc. is a fast-growing biotechnology company developing microfluidic devices for the biopharmaceutical and medical industry. By joining Erbi Biosystems Inc. you will have an opportunity to work on cutting edge technology alongside a skilled team of engineers and scientists creating a new product to accelerate biotechnology innovation.
Erbi Biosystems, Inc. offers a comprehensive benefit plan as well as a culture with opportunity for growth and rewarding challenges.
For positions requiring access to technical data, Erbi Biosystems, Inc. may have to obtain export licensing approval from the U.S. Department of Commerce – Bureau of Industry and Security and/or the U.S. Department of State – Directorate of Defense Trade Controls. As such, applicants for this position – except US Citizens, US Permanent Residents, and protected individuals as defined by 8 U.S.C. 1324b(a)(3) – may have to go through an export licensing review process.
Candidates should be aware that Erbi Biosystems currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19. Newly hired employees must be vaccinated prior to their employment start date. *Certain exemptions may apply.
Erbi Biosystems, Inc. is an Equal Opportunity Employer.