Principal Analytical QA Specialist, Drug Substance
$150,000–$190,000 year
Remote
Job Summary
Oversee all aspects of drug manufacture and testing through clinical development and into commercial phase, providing quality oversight for analytical method development, qualification, validation, transfer, release testing, and stability programs. Review and approve validation protocols, raw data, and reports to enable batch release and disposition decisions while managing quality event resolution investigations for OOS/OOT results and deviations. Collaborate with Technical Operations, Analytical Development, and CDMOs to ensure compliance with cGMPs, VICH guidelines, and FDA CVM regulations for veterinary pharmaceutical products, supporting data integrity assessments and regulatory submission accuracy. Maintain 10% travel availability for supplier audits and cross-functional collaboration.
Required Qualifications
- B.S./M.S. degree in a scientific discipline (Pharmaceutical Sciences, Chemistry, Veterinary Science, or related field)
- Minimum 12 years of relevant pharmaceutical industry experience, with at least 6 years in GxP QA roles
- Strong knowledge of FDA CVM regulations, cGMP, and VICH guidelines applicable to veterinary products
- In-depth working knowledge of drug substance development and manufacturing, analytical method development, validation, release testing, stability programs, and quality systems
- Experience managing CDMOs and collaborating effectively across cross-functional teams
- Capable of working successfully in a team/matrix environment and independently, as required
- Ability to meet deadlines, demonstrate efficient and effective use of time, and handle multiple assignments simultaneously
- Ability to convey both written and verbal information effectively and efficiently
- Demonstrated ability to follow procedures and perform assignments with a high degree of accuracy and careful attention to detail
- Willingness to travel (10%)
Desired Qualifications
- Other Compliance or Regulatory certifications (e.g., RAC, ASQ)
- Experience auditing suppliers, CDMOs, and CTLs
- Experience with Google Workspace applications (e.g., Sheets, Slides, etc.) and electronic Quality Management Systems
- Experience in small molecule pharmaceutical development, routine analytical testing for solid oral dosage forms, and/or veterinary drug products
- Experience with international regulatory environments (EU, Canada, etc.)
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