Manager – Quality Assurance
Posted on 7/19/2023
INACTIVE
Biologic platform therapeutics manufacturer
Company Overview
Coherus' mission is to expand patient access to important, cost-effective medicines and deliver significant savings to the U.S. healthcare system. The company has created the leading biologics platform company solely focused on delivering high-quality biosimilar therapeutics that will expand patient access to life-changing medicines in regulated markets worldwide.
Biotechnology
Company Stage
N/A
Total Funding
$1.2B
Founded
2010
Headquarters
Redwood City, California
Growth & Insights
Headcount
6 month growth
↑ 0%1 year growth
↓ -4%2 year growth
↑ 0%Locations
San Carlos, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Management
Quality Assurance (QA)
CategoriesNew
QA & Testing
Requirements
- Bachelor of Science degree or work experience equivalent to a minimum of 5-7 years of QA experience in a GMP (Mfg/QA/QC) biopharmaceutical environment
- Minimum of 3 years of experience working with contract manufacturing organizations and driving process improvements
- Prior experience in disposition of biopharmaceutical products. Clincal product disposition preferred
- Strong Knowledge of FDA guidelines and regulations regarding cGMPs
- Strong knowledge and demonstrated practice of ICH Guidelines
- Exceptional attention to detail
- Outstanding written, verbal skills and problem solving skills
- Strong computer skills, including all MS Office applications
- Effectively interact with multi-disciplinary functional groups
- Exercise sound and independent judgment and decision making
- Ability to work in a fast-paced, dynamic environment
- Up to ~30% Travel required for this position, typically campaign based
Responsibilities
- Good knowledge base and direct experience of biopharmaceutical manufacturing of intermediates and finished product (i.e., WCB/MCB, drug substance, drug product, final packaged product) and QA oversight
- Review and approval of cGMP documentation, such as master batch records, executed production records, certificates of analyses, quality systems records, to support the disposition of Coherus clinical products
- Participate in regularly scheduled meetings with CMOs
- Drive and troubleshoot quality investigations at CMOs to ensure that all critical quality issues are fully investigated with appropriate actions
- Alert management of product quality operation issues for proper and timely escalation to Product Quality Review Board (PQRB) and Management Review
- Quality review of documents from CMOs for compliance with Coherus BioSciences policies/procedures and cGMPs
- Manage CAPA and Change Controls to support release of clinical products
- Support the final disposition activities of pre-commercial/commercial products
- Support manufacturing process transfers, as well as, process validation activities for late phase clinical programs
- Support inspection readiness and commercialization activities to include BLA authoring, date verification and information request support
- Participate in development of QA processes and SOPs
- Maintain the effectiveness of the Coherus Quality Management System (QMS) including but not limited to
- Deviations
- Change Control
- CAPA
- Provides audit support of Coherus BioSciences CMOs as required
- Contribute to process improvement initiatives across organization and provide support and direction to maintain quality system to recognized standards
- Partner/team with stakeholders across the organization to address compliance related issues and processes
- Support Quality Management with other duties, as required