Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering, or a related scientific discipline.
Minimum of 5 years (Senior Associate) or 8 years (Principal Associate) of experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry, with a strong focus on API manufacturing and/or external supply chain quality.
In-depth knowledge of cGMP regulations (e.g., 21 CFR Part 210/211, ICH Q7) and international quality standards applicable to API manufacturing.
Proven experience in auditing external manufacturing sites and managing quality events (deviations, investigations, CAPAs).
Strong understanding of analytical testing methods, stability programs, and release criteria for APIs.
Excellent communication, interpersonal, and negotiation skills, with the ability to effectively collaborate with diverse internal and external stakeholders.
Demonstrated ability to work independently, prioritize tasks, and manage multiple projects simultaneously in a fast-paced environment.
Strong problem-solving and decision-making abilities with a keen attention to detail.
Proficiency in English
Ability to travel domestically and internationally as required (up to 25%).