Manager, GxP Quality Systems

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.

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

For Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION: 

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

E-Verify:

Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.

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