Senior Specialist, GMP Quality Assurance

Responsibilities

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

Requirements

• Biotech experience preferred
• Education:
• BA or BS degree in a scientific discipline or supplemental Quality education
• Salary Range
• $122,000 - $150,000 USD
• EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:
• E-Verify:
• Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
• #LI-Hybrid

Benefits

Additional Information

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera's mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

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