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

What You’ll Do:

The Senior Director, Quality Systems is a high-impact leadership role responsible for the architecture, implementation, and continuous improvement of our Enterprise Quality Management System (eQMS). You will report to the Vice President, Quality and will serve as the primary architect of our quality framework, ensuring our global operations remain compliant with GxP standards while maintaining the agility required of a growing biotech.

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

Responsibilities:

• Define and execute the long-term vision for the Quality Management System (QMS) to support global clinical development and future commercialization
• Provide Quality oversight for GxP systems change controls. Support validation planning, execution, approvals
• Act as the Business Owner for Veeva QualityVault. Lead the optimization of modules including Document Control, Training, Deviations, CAPA, and Change Control
• Establish and lead Quality Management Reviews (QMR). Develop and report on Key Quality Indicators (KQIs) and metrics to senior leadership to drive proactive risk management
• Ensure the QMS meets global regulatory requirements (FDA 21 CFR Parts 11, 210, 211, and 820; ICH E6; EudraLex Volume 4)
• Lead the QMS strategy for inspection readiness. Serve as a key interface during regulatory inspections (FDA, EMA, etc.) and oversee the internal and vendor audit programs
• Champion a culture of Quality. Streamline complex workflows to reduce cycle times for document approvals and deviation closures without compromising compliance
• Build and mentor a high-performing team of Quality professionals, fostering a collaborative environment that balances technical rigor with pragmatic problem-solving

Required Qualifications:

• 12+ years of experience in Quality Assurance within the Biotech/Pharmaceutical industry, with at least 5 years in a senior leadership capacity
• Direct experience implementing or managing Veeva QualityVault is mandatory. You should be proficient in configuring workflows and leveraging the platform for data-driven decision-making
• Proven track record in mid-sized companies navigating the transition from early-phase clinical trials to late-stage pivotal studies
• Deep knowledge of global GxP regulations and experience participating in (or leading) successful regulatory inspections
• Exceptional ability to translate complex quality requirements into actionable business strategies for non-quality stakeholders

Education:

• Bachelor’s degree required, scientific or engineering discipline preferred
• Advanced degree preferred

What You’ll Do:

The Manager of GxP Quality Systems will support Quality Management System processes, procedures, systems, training, and tools, ensuring quality and compliance are achieved and maintained across GxP functions. The role will report to the Senior Manager of GxP Quality Systems.

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

Responsibilities:

• Track and support closure of Quality Events (e.g., Deviations, CAPAs, etc.)
• Support management of GxP training program, maintenance of GxP training curriculum/matrix, and facilitation and scheduling of GxP trainings
• Conduct Document Control reviews on controlled quality documents and ensure timely periodic reviews and implementation of document change requests
• Support establishment, tracking, measurement, and reporting on metrics for the evaluation effectiveness of the Quality Management Systems
• Support the management of the electronic document management system (Veeva QualityDocs), the electronic learning management system (Veeva Vault Training), and the electronic quality management system (Veeva QMS) as Business Administrator
• Ensure the systems remain in a validated state, documenting changes via IT Change Controls, and executing scripts with evidence
• Evaluate opportunities for continuous improvements across the systems
• Work with stakeholders to ensure appropriate documentation of Service Provider selection, qualification, and evaluation/requalification
• Support development of metrics related to Service Provider qualifications and Service Provider Quality Events
• Manage and track Audit Schedule ensuring adherence to Audit Program and timeliness of deliverables

Required Qualifications:

• Minimum of 6+ years of experience in FDA regulated industry
• Previous hands-on experience with Veeva Quality Docs, Veeva Training, and Veeva QMS required
• A strong customer focus and ability to prioritize and adapt to business needs are required
• Strong business partner with all Functional Areas to ensure efficient collaboration and to drive results
• Self-motivated, detail oriented, well-organized, and able to demonstrate success with managing multiple projects simultaneously and other priorities
• Ability to resolve day-to-day issues efficiently while maintaining compliance with applicable industry standards
• Clear, concise writing skills and good verbal communication and presentation skills

Education:

• Bachelor’s degree in Life Sciences or a related field