Vice President, Quality Assurance

About CG Oncology, Inc.

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.

About the role

The Vice President of Quality Assurance is responsible for the strategy and execution oversight of the Quality Assurance (QA) department that operates virtually. The VP is a key-member of the leadership team. The position is responsible for leading the Quality Assurance activities at the company as both a clinical and commercial manufacturing organization. The VP is responsible for oversight of the quality systems and assuring the overall GCP, GxP, GLP and GMP compliance with current regulatory requirements and guidelines. executive who thrives in a fast-paced, matrixed environment.

Location: Remote

Essential Functions

• Plans and directs all aspects of the Quality Management Systems (QMS) throughout the organization, including GxP training and education, SOP's, master manufacturing records, specifications, equipment and process qualifications, analytical test reports, OOS investigations, non-conformance reports, CAPA's, change control system, supplier qualification, deviations, computerized electronic systems etc.
• Accountable for the performance of the Quality Assurance team including compliance, measuring Key Performance Indicators, internal and external customer satisfaction, timely testing and release, labeling, relationships with regulators and customers, talent management, departmental budget and effective communications related to quality initiatives.
• Assure compliance metrics are appropriate measures of life cycle and new product compliance. Conduct trend analysis of audit/inspection observations and communication of results expediently to applicable groups. Expedite key documentation processes requiring a high level of responsiveness for Exceptions, Out of Specification results, Corrective Actions and Preventative Actions.
• Serve as a technical / quality system resource and actively collaborate with Manufacturing / R&D / PMO / Supply Chain / Regulatory Affairs and Medical / Commercial organizational counterparts making quality decisions for new project teams and life cycle product teams. This includes leadership on Quality by Design, Failure Mode & Effect Analysis, and Risk-Based Decision Making.
• Optimize, manage the internal auditing program, and collaborate, cross-functionally, to ensure compliance; plan and execute compliance audits of internal operations as they relate to GxPs and drive timely completion of associated corrective actions.
• Oversee the management of external and Health Authority inspections, ensuring compliance with policies, procedures, and regulatory requirements. Function as key liaison for local, state, federal, and global regulatory agency inspections. Proactively seek to affect change to reduce the number of observations identified during audits/inspections and ensure company is aligned with current regulatory expectations.
• Oversee and review recommendations and implementation of improvements induced by new regulations, agency guidance documents, industry standards, modern technologies, and internal needs.
• Conduct ongoing surveillance of worldwide regulations and establish procedures and policies to comply with everchanging regulatory environment. Maintain awareness of science and industry trends and integrate appropriately into work focus.
• Drive Change Management Process, Materials Management Process and in-coming goods processes and support CG Oncology’s manufacturing as well as quality systems supporting Clinical Trial Material manufacture and release.
• Manage CG Oncology’s QMS and Documentation Department responsible for the review / approval of a GxP procedures and records retention. This includes the company-wide training, determination of training needs against metrics, and management of employee training records. This also includes supporting computer system validation documentation and business continuity documentation needs.

Qualifications

• Bachelor’s Degree in relevant/scientific field.
• 15 years of progressively increasing quality leadership experience within the pharmaceutical industry required including interfacing regularly with Federal Drug Administration, Nuclear Regulatory Commission, and other regulatory bodies.
• Minimum of 10 years of managerial experience, demonstrated history of experience leading people towards meeting the organization's vision, mission and goals by providing an inclusive workplace that fosters the development of others, facilitates cooperation and teamwork.
• Experience leading regulatory agency inspections, ensuring compliance with policies, procedures and regulatory requirements, experience overseeing or acting as liaison for local, state, federal, and global regulatory agency inspections is required.
• Significant work experience in a finished pharmaceutical cGMP manufacturing environment as well as radiopharmaceutical manufacturing is required as is experience in Clinical Quality Assurance activities.
• Experience leading change within an organization is required

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.

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 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 –In 2025 we will observe 14 holidays
• RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary
• HEALTH (MEDICAL, DENTAL, VISION) – PPO & 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.

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