What You’ll Do:

The Senior Manager, GMP Quality Assurance will collaborate internally with Quality Assurance, Regulatory Affairs, and CMC departments. As needed, they will work with external Approved Vendors to ensure oversight and compliance.  The Senior Manager will manage GMP activities related to Regulatory Standard Materials, Intermediates, Drug Substance, and Drug Product.  The Senior Manager will help develop and continuously improve Quality System Procedures related to GMP activities, maintain documentation for compliance with quality and regulatory standards, and will collaborate closely with internal cross-functional teams.  The Senior Manager will report to the Senior Director, GMP Quality Assurance.

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

Responsibilities:

• Review and approve Vendor GMP documentation
• Review and approve Vendor and Kailera GMP Quality Events
• Review and approve master batch records
• Review executed batch records for associated Regulatory Standard Materials, Intermediates, and Drug Substance for Kailera’s program and prepare batch file for final batch disposition
• Review quality deviations, change controls, CAPA’s and other vendor documentation as needed
• Provide input on the creation of Vendor Quality Agreements
• 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:

• 8+ years of experience in an FDA regulated Pharmaceutical Industry with GMP experience
• Extensive understanding and knowledge of industry standards, concepts and 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
• Proficient in Veeva Quality Docs and Veeva QMS
• Demonstrates proven track record of communication with internal and external Vendors
• A strong team player with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations, and business needs
• Ability to identify quality issues requiring escalation
• Provide solutions to issues. Solutions are imaginative, thorough, practical, and consistent with objectives
• Flexibility/ability to provide a solution-based approach to emerging challenges/changing priorities
• Clear, concise writing skills and good verbal presentation skills
• Self-motivated, detail oriented, well organized, and able to demonstrate success with managing multiple projects simultaneously and other priorities
• Ability to interact constructively and efficiently with co-workers within and across departments and Management, as well as with Vendors in professional and collaborative manner
• Communicate decisions and recommendations with clear justification
• Proactive approach to problem solving

Preferred Qualifications:

• Biotech experience preferred

Education:

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