Coherus Oncology · 1 month ago
Vice President, Quality Control
Camarillo, CA
Full-time
Onsite
Director/Executive
$300K/yr - $340K/yr
15+ years expCoherus Biosciences is a biopharmaceutical company focused on the commercialization of protein-based therapeutic products. The Vice President of Quality Control will be responsible for leading the Quality Control organization, ensuring compliance with regulatory expectations, and managing QC systems for drug substance and product lifecycle management.
BiotechnologyHealth CareMedicalOncologyTherapeutics
Responsibilities
Oversee the operations of all Quality Control activities for internal and external testing
Provide input and guidance to strategic partners as
Represent the QC organization in interactions with other functional These include Regulatory Affairs, Clinical, Project Management, Manufacturing, Finance, etc
Establish, oversee, and manage QC documentation systems including but not limited to, change control, SOPs, protocols/reports, training records, job descriptions etc
Lead the implementation of a QC Systems that will assure that all aspects of Quality Control testing are in compliance with CMC requirements as well as internal SOP’s
Assist the Company with the development and management of a comprehensive budget for Quality Control activities
Provide mentorship to direct reports and maintain clear communication on performance to direct
Alert executive management of product quality issues for proper and timely escalation to Product Quality Review Board (PQRB) and Management Reviews
Serve as a Senior Management representative on Quality Management Reviews (PQR, QMR and APQR) and work with team to identify and address risks associated with the execution of the QMS and performance of the applicable products
Travel as required, both domestically and internationally, to ensure compliance to the Company’s Quality Management Systems
Qualification
Required
BS degree in relevant scientific discipline or technical field is required; advanced degree is preferred
Ability to function effectively as a member of project teams with demonstration of superior leadership skills
Experience with using a 'phase-appropriate' approach
Extensive knowledge of GMP quality systems and regulatory requirements
Complete understanding of the commercialization of protein-based therapeutic products in the US, and preferably, Europe, Japan, and the non-ICH geographies
Excellent oral and written communication skills, auditing skills, and proven ability to work independently and manage effectively in a matrixed environment
A hands-on, 'roll up the sleeves' professional willing to try innovative things, have a driving sense of urgency and an experienced 'make it happen' orientation within a program-based, matrixed work environment
Exceptional communication skills, both written and verbal, are required. This candidate must have the communication skills and experience to effectively present the Company's Quality programs to the FDA and other regulatory authorities from around the world
Articulate, persuasive and demonstrated ability to influence others, while employing sound judgment and good sense
Ability to provide clear direction in a matrixed organization
An exceptional leader with the strong management and leadership skills necessary to set a vision, create and lead a first class, results oriented Quality group
An understanding of the importance of meeting corporate and program objectives
Possesses the strongest ethics and integrity
Ability to travel both domestically and internationally, up to 25%
Demonstrated ability to write reports, presentations, and business correspondence and to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
Preferred
A minimum of 15 years of hands on experience in a Quality organization within the biotechnology industry is preferred, which shall include at least 10 years of hands on experience in managing QC organizations/groups
Company
Coherus Oncology
Coherus Oncology is a fully integrated commercial-stage innovative oncology company with an approved next-generation PD-1 inhibitor, LOQTORZI, and a promising pipeline that includes two mid-stage clinical candidates targeting liver, lung, head & neck, and other cancers.
201-500 employees
H1B Sponsorship
Coherus Oncology has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2022 (6)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$1.27BKey Investors
Pharmakon AdvisorsNorthern Star PartnersShanghai Junshi Biosciences
2023-05-15Post Ipo Equity· $50M
2022-01-07Post Ipo Debt· $100M
2022-01-01Post Ipo Debt· $400M
Leadership Team
Dennis Lanfear
Founder, President, and Chief Executive Officer
Jodi Sievers
Vice President, Investor Relations & Corporate Communications
Recent News
2026-01-06
2026-01-05
Company data provided by crunchbase