What You’ll Do:

The Senior Specialist, GMP Quality Assurance will collaborate internally with QA, RA, and CMC departments. As needed, work with external Approved Service Providers to ensure oversight and compliance. The Senior Specialist will perform review of drug substance/drug product manufacturing records and associated documents (i.e. deviations) for product that will be released for use in Kailera phase I-III clinical programs. The Senior Specialist will help continuously improve Quality System Procedures related to GMP activities related to their function and will collaborate closely with internal cross-functional teams.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Review and approve Service Provider GMP documentation
• Review and approve master batch/packaging records
• Review executed batch/packaging records for Intermediates, Drug Substance, and Drug Product
• Prepare batch file for final batch disposition for Kailera’s Phase I-III clinical programs
• Review GMP Quality Events, change controls, CAPA’s, and other GMP documentation as needed
• Identify and escalate issues effectively
• Compile data for Quality System Reviews
• Evaluate GMP activities for continuous improvement opportunities
• Support creation and continuous improvement of Kailera procedures
• Other Quality Assurance responsibilities as assigned

Required Qualifications:

• 6+ years of experience in an FDA regulated Pharmaceutical Industry with GMP experience
• Understanding and knowledge of industry standards, concepts, current cGMP (21 CFR Parts 210 & 211 & Part 11 and EudraLex), and other agency standards and guidance as they relate to quality systems/quality assurance
• Experience with review of GMP manufacturing/packing records (Master/Executed Batch Records, Deviations, Change Controls, etc.) associated with Phase I-III clinical studies
• Proficient in Veeva QualityDocs and Veeva QMS a plus
• Demonstrates proven track record of communication with internal and external Service providers
• Ability to identify quality issues requiring escalation
• Clear, concise writing skills and good verbal presentation skills
• Self-motivated, detail oriented, well organized, and able to manage multiple projects
• Ability to interact constructively and efficiently with co-workers within and across departments and Management, as well as with Service providers in a professional and collaborative manner

Preferred Qualifications:

• Biotech experience preferred

Education:

• BA or BS degree in a scientific discipline or supplemental Quality education