Overview
Senior Quality Compliance Specialist Jobs in San Rafael, CA at NewGen Surgical, Inc.
Responsibilities
Provide strategic direction and oversight for the management and development of the Quality Management System to support combination product development and commercialization.
Contribute to the ongoing review, strategy development, and operational planning to ensure that all Quality Assurance programs meet applicable regulations and standards
Evolve Quality Systems parameters to meet requirements of various drug and device development stages
Partner with GXP Operations to assist in oversight of contract service providers.
Assist Regulatory Affairs in the preparation and review of product development data for regulatory submissions
Implement pre-approval inspection readiness program
Manage individual and group workload to meet Company objectives
Write, Review, Edit and Approve Standard Operating Procedures.
Write, Review, Edit and Approve Analytical Test Methods.
Manage Vaxess’ Document Control, Training, Equipment and Metrology programs.
Maintain an ongoing understanding of and adaptation to the pharmaceutical, biologics, and medical device industries including staying abreast of quality issues within industry and government.
Preferred Experience
Bachelor’s degree in Life Sciences field
3 to 5 years in Quality Assurance, in the medical device, biologics and/or pharma industries; or 7+ years working in a GXP Environment.
Experience in pharmaceutical, biological, and combination product development from preclinical drug development through commercialization preferred.
Knowledge with GXP environments.
Quality management of contract service providers (agreements, audits, specification setting, product release)
Creative in approach to problem-solving
Strong knowledge of product development technical strategy as well as systems strategy; must also be able to tie technical and systems strategies into the overall business strategy.
Experience in managing regulatory inspections
Experience in performing audits of suppliers
Demonstration of high-level leadership skills
Excellent written and verbal communication skills
Excellent skills in managing technical and human resources
Experience in supporting the development of data for regulatory applications and submissions
Experience in leading pre-approval inspection readiness activities
Personal Skills/Attributes/Qualifications
Timeliness in achieving deliverables
Organizational skills
Superior written and verbal communication skills
Collaborative leader
Strong negotiating, influencing and problem-solving skills
Ability to productively interact with contracted service providers and representatives of various government auditing agencies
Detail oriented and hands on in the work environment
<25% Job Type: Full-time Pay: $120,000.00 - $150,000.00 per year Schedule: Monday to Friday Work Location: In person Title: Senior Quality Compliance Specialist
Company: NewGen Surgical, Inc.
Location: San Rafael, CA
