Senior Specialist, Quality Assurance – Drug Substance
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Job Description
Senior Specialist, Quality Assurance executing QA activities for drug substance manufacturing at CG Oncology. Collaborating across teams to ensure compliance with GMP standards and support quality readiness initiatives.
Responsibilities:
- Support the implementation, revision, and maintenance of QA programs, policies, and procedures to ensure compliance with cGMP, FDA, and ICH requirements.
- Assist in updating SOPs to mitigate compliance gaps and support commercial QA readiness.
- Support QA activities related to drug substance tech transfer, process performance qualification (PPQ), and preparation for process validation activities.
- Ensure QA compliance of validation protocols, reports, and associated GMP documentation during execution.
- Perform QA review of batch production records, validation data, deviation investigations, and analytical documentation associated with drug substance manufacturing to ensure accuracy, completeness, and compliance with GMP standards.
- Support timely disposition activities once all required data is available.
- Serve as a QA point of contact for assigned contract manufacturers and partners by supporting QA oversight activities.
- Support and participate in GMP audits for vendor qualification or requalification (minimum of two), including preparation, execution support, and documentation of findings.
- Perform QA review of manufacturing, validation, and analytical documents related to API/drug substance release testing, stability programs, raw materials, intermediates, and analytical method qualification/validation to ensure compliance with regulatory expectations.
- Support the review and resolution of quality system events, including deviations, CAPAs, change controls, and out-of-specification investigations.
Requirements:
- Bachelor’s degree (BS/BA) in a relevant scientific discipline (e.g., Biology, Chemistry, Pharmaceutical Sciences, or related field).
- Minimum of four to six (4–6) years of experience in Quality Assurance and/or Quality Systems within the biotechnology or pharmaceutical industry.
- Direct experience supporting GMP-regulated drug substance/API manufacturing, including batch record review, process validation support, and documentation compliance.
- Experience supporting contract manufacturing organizations (CMOs) or external vendors in a QA capacity.
- Hands-on experience with quality systems such as deviations, CAPAs, change control, and/or OOS investigations.
- Working knowledge of cGMP regulations, FDA guidelines, ICH standards, and industry best practices related to drug substance/API manufacturing and process validation.
- Ability to review and interpret technical documentation (batch records, validation protocols/reports, analytical data).
- Strong organizational skills with the ability to manage multiple priorities and meet deadlines.
- Proficiency with electronic quality systems and document management platforms.
- Ability to travel domestically and internationally (~20%) as needed.
Benefits:
- FULLY REMOTE WORK ENVIRONMENT
- REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off
- HOLIDAYS –In 2026 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
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