Senior 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 Senior Manager of Quality Systems will collaborate with GxP departments and external Approved Vendors (Vendor).  Senior Manager will have a GxP focus and will ensure that QMS processes, procedures, systems, training, and tools are compliant and user friendly for the organization to achieve and maintain quality and compliance.  The Senior Manager will report into the Associate Director of Quality Systems.

Preferred location: Waltham, MA or San Diego, CA (onsite or hybrid 2-3 days per week).

Responsibilities:

• Work with stakeholders to ensure documented Vendor selection, qualification, and evaluation/requalification.
• Support development of metrics related to Vendor Quality and Vendor Quality Events.
• Manage External and Internal Audit schedule.
• Track audit report completion, audit response from Vendor, and any remaining open observations via a CAPA to closure.
• Assist in reviewing and updating Quality Agreements with stakeholder to ensure compliance with internal processes and requirements.
• Support the management of the electronic document management system (Veeva - QualityDocs), the electronic learning management system (Veeva – Quality Training), and the electronic quality management system (Veeva – QMS) as Business Administrator.
• Document Veeva Quality Vault changes via an IT Change Control and execute scripts with evidence.
• Evaluate changes to Veeva and look for continuous improvements.
• Support continuous improvement projects (including scope definition, planning, communication, design, project management, and implementation) for GxP computerized systems in Quality.
• Support training of Functional Areas, co-development, and facilitate of appropriate training for personnel involved in the execution of Quality Systems processes.
• Track and support closure of Quality Events (e.g., deviations, CAPAs, etc.)
• Track GxP training compliance.
• Review and process documents in Veeva to ensure the correct use of templates (format), correctly entered metadata, naming conventions, document types, etc.
• Collaborate with Functional Areas to ensure timely implementation of document change requests.
• Support establishment, tracking, measurement, reporting on metrics and evaluation effectiveness of the QMS.
• Support management of GxP training program, maintenance of GxP training curriculum/matrix, and facilitation and scheduling of GxP trainings.
• Ensure a continual state of inspection readiness for the QMS elements.
• Participate and support audits, inspection readiness activities, and regulatory inspections. Interface with regulatory agencies as required.
• Other Quality Assurance responsibilities, as assigned.

Required Qualifications:

• Minimum of 5 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 a focus on collaborating and delivering results.
• Self-motivated, detail oriented, well organized, and able to demonstrate success with managing multiple projects simultaneously and other priorities.
• Understanding and knowledge of applicable industry regulations.
• Ability to interact constructively and efficiently within and across Functional Areas and Management.
• Ability to resolve day-to-day issues efficiently while maintaining compliance.
• Clear, concise writing skills and good verbal communication and presentation skills.
• Proficiency in Microsoft Word, Power Point, Excel, Adobe, and SharePoint.
• Comply with Company quality standards/SOPs and implementation of new quality systems.
• Provide imaginative, thorough, and practical solutions to problems.
• Solve conflict and address workplace issues in professional and collaborative manner.

Education:

• Bachelor’s degree required.

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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