Associate Director, Product Quality Leader (Tech Ops)

Location: Remote US-Based

Essential Functions:

• Provide product quality oversight through the lifecycle, from clinical to commercial stages, ensuring robust quality management throughout development.
• Manage the creation of, and lifecycle, relevant CMC documentation such as QTPP, Product Specifications, CQA assessment, control strategy, etc.
• Identify and lead the strategy when process and analytical changes are required (e.g., author comparability and analytical bridging documents)
• Work with QC on strategic oversight of assay validation, reference standard, raw materials and shelf-life strategy
• Be the Quality Subject Matter Expert for the product, with a deep understanding of the manufacturing process and analytical methods
• Author and/or review CMC Mod 3 BLA regulatory submission
• Support QA with quality systems for change control, CAPA, batch release, and other critical processes within Technical Operations.
• Lead risk management activities, including risk assessments and risk mitigation planning, to ensure product integrity and patient safety.
• Work closely with Technical Operations, R&D, Quality Control, Regulatory Affairs, and Supply Chain teams to support technology transfer, process validation, and other technical projects.
• Identify opportunities for process improvement and implement quality improvement initiatives to enhance efficiency, compliance, and product quality.
• Lead and mentor a team of quality professionals, fostering a culture of collaboration, accountability, and continuous learning.

Qualifications:

• Bachelor’s or Master’s degree in a life sciences field such as Biology, Chemistry, or Engineering. An advanced degree or certification in Quality (e.g., ASQ, CQE) is a plus.
• 8+ years of experience in biopharmaceutical quality assurance or quality control, with at least 3-5 years in a leadership role.
• Strong knowledge of cGMP and regulatory requirements for biologics, oncology products, or gene/cell therapy manufacturing.
• Experience with authoring and review of regulatory documentation (FDA, EMA, and other regulatory inspections and audits).
• Knowledgeable in cGMP, FDA, USP, regulations and guidelines related to the manufacture and testing of Gene therapy products and ensures compliance.
• A commitment to quality that is patient-centered, understanding the critical importance of quality and compliance in advancing cancer therapies for patients in need.
• Proficiency in quality systems management, including CAPA, change control, and deviation management.
• Expertise in product quality lifecycle management, with hands-on experience in process validation and product release.
• Proven understanding of quality by design principles
• Commitment to CG Oncology’s mission to deliver innovative cancer therapies.
• Willingness to work onsite as needed, with occasional travel to support inspections, audits, or business needs.

The U.S. target annual salary range for this remote, full-time, position is currently set at ($175,000-$182,000). 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 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 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.