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: DIRECTOR, QUALITY ASSURANCE – COMMERCIAL GMP

Location: Remote US-Based

Essential Functions:

• The Director of Regulatory Affairs - CMC will be responsible for all activities involving Quality Assurance and compliance with applicable regulatory and cGMP requirements, serve as the QA leader on relevant project teams, and function as the QA contact for all cGMP vendors as required.
• This individual will lead and oversee the planning and execution of all validation activities conducted at critical cGMP vendors leading toward BLA and commercialization, development and implementation of policies and procedures to ensure quality standards in compliance with relevant regulatory and quality guidelines for all cGMP directives.
• They will provide QA support and guidance to various cross-functional teams and ensure all applicable regulatory requirements are considered and appropriately incorporated into clinical and future commercial products.

Qualifications:

• Bachelor's degree in a relevant scientific discipline.
• Eight (8) years of progressive managerial and Quality Assurance experience at a high-growth pharmaceutical / biotechnology company, experience in therapeutic area in complex field (e.g., oncology, virology, etc.).
• Experience working with all levels of management and consulting with key business stakeholders.
• Demonstrated understanding and strategic application of regulations and guidelines for drug development at IND and NDA/BLA stages including familiarity with international regulatory requirements and documentation.
• Demonstrated experience of successful validation documentation packages related to product/process validation in collaboration with external vendors/partners and internal stakeholders.).
• Established working knowledge of regulatory guidelines and regulations (US and international).
• Ability to travel to visit external vendors/partners and attend relevant conferences or meetings within and outside of the United States.

The U.S. target annual salary range for this remote, full-time, position is currently set at $190,000 - $210,000. 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 meet most 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) – HMOs, PPOs & HDHP – Anthem/MetLife
• 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.