CG ONCOLOGY INC
Manager, Commercial Quality Assurance
CG ONCOLOGY INC, Irvine, California, United States, 92713
Are you ready to make a difference in the world and become part of our patient-centered team that is focused on Attacking Bladder Cancer for a Better Tomorrow? At CG Oncology, we believe that by having exceptionally talented individuals on our team who share our passion and enjoy working together, we can truly achieve our Vision and Mission to benefit patients around the world.
Every day we are making significant advancements across our multiple pipelines and are growing rapidly to meet the needs of our patients who cannot afford to wait to benefit from our novel immunotherapies. Please review this job posting and our Values and if they resonate with you and are what you expect from your organization and team, then we would like to hear from you.
We invite you to review our website to learn more about our company and team by visiting our website at https://www.cgoncology.com/careers/#overview.
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Role:
Manager, Commercial Quality Assurance Location:
Remote US-Based Essential Functions: QA Program Development:
Support the development, improvement, and management of QA programs, policies, and procedures to ensure cGMP compliance. Vendor and Partner Management : Serve as the primary or support QA contact for specified vendors, contract facilities, or joint development collaborators. Through QA oversight, project team participation, and QA representation for batch manufacture oversight, validation activities, change management, and other GMP related activities, ensure cGMP requirements are met. o
Support the process for Sponsor batch disposition.
Document Review and Management:
Perform QA review of manufacturing records, validation related records, and documents submitted to regulatory agencies. GxP Auditing and Inspections:
Lead and manage cGMP auditing of vendors. Support inspection readiness programs to ensure that the Sponsor and vendors have successful inspectional outcomes. Analytical Document Review:
Review analytical documents related to stability, reference standards, and analytical method qualification/validation. Issue Resolution:
Provide input on the vendor’s Quality System events, including change control, deviations, investigation, out-of-specifications, and CAPAs. Other : Perform other related duties as assigned or requested. Qualifications: BS/BA in a relevant scientific discipline. At least six (6) years of experience in Quality Systems and Quality Assurance processes, including development and documentation within the Pharmaceutical/Biotech industry A minimum of two (2) years demonstrating management of QA projects including directing, organizing personnel to complete critical timeline objectives. Experience with commercial drug manufacturing and manufacturing process validation; familiarity with Federal laws and regulations affecting the pharmaceutical industry. Comprehensive knowledge of GMP regulations, ICH, and FDA guidelines critical to product manufacture of a biologic and small molecule Ability to travel 25% The U.S. target annual salary range for this remote, full-time, position is currently set at
$140,000-$150,000.
The actual base salary offered for this role will vary depending on job-related knowledge, skills, market factors, experience and considering internal equity. In addition, to the base salary, CG Oncology offers a very attractive set of Total Rewards (including bonus and equity) and Well-Being Benefits provided as part of the overall compensation package for this role. Please visit https://www.cgoncology.com/careers/#rewards for a listing of these rewards and benefits. Total Rewards CG Oncology offers very competitive and comprehensive Total Rewards, helping to support and reward our global team of high-performing employees focused on developing bladder-saving therapeutics for patients afflicted with bladder cancer. HIGHLY COMPETITIVE SALARIES ANNUAL PERFORMANCE/MERIT REVIEWS ANNUAL PERFORMANCE BONUSES EQUITY SPECIAL RECOGNITION Well-Being Benefits In addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to the meet the majority of the needs of our unique and growing workforce.
These benefits are designed to support our team to achieve a healthy balance between work and their personal lives to remain refreshed, engaged, and creating an environment where each person can find a deeper meaning and purpose in their work. Well-Being Benefits eligibility begins the 1st of the month after hire.
While a majority of these benefits are for our US-based workforce, we continue to assess comparable levels of benefits for our international team members that are aligned with country-specific regulations and their national programs offered. FULLY REMOTE WORK ENVIRONMENT REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off HOLIDAYS – We observe 12 Holidays/year RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary HEALTH (MEDICAL, DENTAL, VISION) – PPOs & HDHP – Cigna/Principal HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More CG Oncology is an Equal Opportunity Employer: All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
At CG Oncology, we are building a community of intelligent and passionate team members that share our Vision, Mission and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability. Please note that CG Oncology does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or client information submitted to our careers page or any employee of CG Oncology by any search firm or agency without an applicable contract in place will become the property of CG Oncology and no fee(s) will be paid.
Manager, Commercial Quality Assurance Location:
Remote US-Based Essential Functions: QA Program Development:
Support the development, improvement, and management of QA programs, policies, and procedures to ensure cGMP compliance. Vendor and Partner Management : Serve as the primary or support QA contact for specified vendors, contract facilities, or joint development collaborators. Through QA oversight, project team participation, and QA representation for batch manufacture oversight, validation activities, change management, and other GMP related activities, ensure cGMP requirements are met. o
Support the process for Sponsor batch disposition.
Document Review and Management:
Perform QA review of manufacturing records, validation related records, and documents submitted to regulatory agencies. GxP Auditing and Inspections:
Lead and manage cGMP auditing of vendors. Support inspection readiness programs to ensure that the Sponsor and vendors have successful inspectional outcomes. Analytical Document Review:
Review analytical documents related to stability, reference standards, and analytical method qualification/validation. Issue Resolution:
Provide input on the vendor’s Quality System events, including change control, deviations, investigation, out-of-specifications, and CAPAs. Other : Perform other related duties as assigned or requested. Qualifications: BS/BA in a relevant scientific discipline. At least six (6) years of experience in Quality Systems and Quality Assurance processes, including development and documentation within the Pharmaceutical/Biotech industry A minimum of two (2) years demonstrating management of QA projects including directing, organizing personnel to complete critical timeline objectives. Experience with commercial drug manufacturing and manufacturing process validation; familiarity with Federal laws and regulations affecting the pharmaceutical industry. Comprehensive knowledge of GMP regulations, ICH, and FDA guidelines critical to product manufacture of a biologic and small molecule Ability to travel 25% The U.S. target annual salary range for this remote, full-time, position is currently set at
$140,000-$150,000.
The actual base salary offered for this role will vary depending on job-related knowledge, skills, market factors, experience and considering internal equity. In addition, to the base salary, CG Oncology offers a very attractive set of Total Rewards (including bonus and equity) and Well-Being Benefits provided as part of the overall compensation package for this role. Please visit https://www.cgoncology.com/careers/#rewards for a listing of these rewards and benefits. Total Rewards CG Oncology offers very competitive and comprehensive Total Rewards, helping to support and reward our global team of high-performing employees focused on developing bladder-saving therapeutics for patients afflicted with bladder cancer. HIGHLY COMPETITIVE SALARIES ANNUAL PERFORMANCE/MERIT REVIEWS ANNUAL PERFORMANCE BONUSES EQUITY SPECIAL RECOGNITION Well-Being Benefits In addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to the meet the majority of the needs of our unique and growing workforce.
These benefits are designed to support our team to achieve a healthy balance between work and their personal lives to remain refreshed, engaged, and creating an environment where each person can find a deeper meaning and purpose in their work. Well-Being Benefits eligibility begins the 1st of the month after hire.
While a majority of these benefits are for our US-based workforce, we continue to assess comparable levels of benefits for our international team members that are aligned with country-specific regulations and their national programs offered. FULLY REMOTE WORK ENVIRONMENT REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off HOLIDAYS – We observe 12 Holidays/year RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary HEALTH (MEDICAL, DENTAL, VISION) – PPOs & HDHP – Cigna/Principal HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More CG Oncology is an Equal Opportunity Employer: All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
At CG Oncology, we are building a community of intelligent and passionate team members that share our Vision, Mission and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability. Please note that CG Oncology does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or client information submitted to our careers page or any employee of CG Oncology by any search firm or agency without an applicable contract in place will become the property of CG Oncology and no fee(s) will be paid.