Manager, Quality Control

CG Oncology; United States; Remote; USD 119,000 - 140,000; Full time

Job summary

A leading company focused on innovative cancer therapies is seeking a Manager of Quality Control. This role involves overseeing quality control processes, managing documentation, and ensuring compliance with industry standards. Ideal candidates will have a strong background in microbiology and biotech, along with excellent communication skills. The position offers a fully remote work environment and competitive compensation.

Benefits

Flexible Time Off

401K

Health Plans

Disability Insurance

Life Insurance

Qualifications

• 5+ years in the biotech industry.
• Experience with drug substances/products and CMO collaboration.

Responsibilities

• Manage QC activities related to commercialization.
• Review and approve assay development and regulatory submission documents.
• Ensure CMC documentation is compliant with regulations.

Skills

Organizational Skills

Problem Solving

Communication

Education

BSc or MSc in Chemistry

Pharmaceutical Sciences

Job description

Join to apply for the Manager, Quality Control role at CG Oncology

About CG Oncology, Inc.

Are you ready to make a difference in the world and become part of our patient-centered team focused on Attacking Bladder Cancer for a Better Tomorrow? At CG Oncology, we believe that having exceptionally talented individuals who share our passion and enjoy working together enables us to achieve our Vision and Mission to benefit patients worldwide.

We are making significant advancements across our pipelines and growing rapidly to meet the needs of patients awaiting our novel immunotherapies. If our values resonate with you, we look forward to hearing from you.

About The Role

The QC Manager will be a key contributor within the TechOps QC/Analytical team, providing technical expertise in quality control and analytical testing. The role focuses on quality control processes, microbiology, raw materials, and supporting clinical and commercial products through technical documentation and operational tasks.

Location

Remote

Essential Functions

• Serve as an internal expert in microbiology testing, raw materials, and analytical methods for oncolytic adenovirus products.
• Manage QC activities related to commercialization, including microbiology and fill-finish processes.
• Review and approve assay development, validation reports, and regulatory submission documents.
• Author sections of IND, BLA, NDA applications related to raw materials, comparability, stability, and standards.
• Support regulatory strategies and author QC content for submissions.
• Communicate complex scientific concepts clearly to diverse stakeholders.
• Participate in strategic discussions on QC and analytical topics.
• Provide instructions and troubleshooting support for manufacturing activities.
• Ensure CMC documentation is complete, organized, and compliant with regulations.
• Advise on microbiology events and ensure quality systems meet industry standards.
• Coordinate with manufacturing, quality, and supply chain teams.
• Manage multiple priorities in a dynamic, global environment.
• Operate independently with limited supervision.
• Maintain knowledge of cGMP, FDA, USP regulations related to gene therapy products.

Qualifications

• BSc or MSc in chemistry, pharmaceutical sciences, or related field.
• 5+ years in the biotech industry.
• Experience with drug substances/products, CMO collaboration, and cross-functional teams.
• Strong organizational and operational skills.
• Ability to interpret data and draw conclusions.
• BLA experience and knowledge of biologics manufacturing are assets.
• Understanding of biological processes, gene therapy, and industry regulations.
• Excellent communication and problem-solving skills.

Note: CG Oncology does not accept unsolicited resumes from search firms or agencies without a contract. Resumes submitted without a contract will be property of CG Oncology.

Total Rewards & Well-Being Benefits

Competitive salaries, performance bonuses, equity, and recognition programs. Benefits include fully remote work, flexible time off, holidays, 401K, health plans, HSA/FSA, disability and life insurance, and additional voluntary benefits.

Equal Opportunity Employer

CG Oncology values diversity and encourages applications from all backgrounds. We are committed to maintaining an inclusive environment.

Pay Range

$119,000 - $140,000 USD per year (Remote, US)