Kailera Therapeutics, Inc.

Associate Director, Clinical Quality Assurance

Waltham, Massachusetts · Director · Full-time

Sponsorship not specified$155k-$190kDetected 15 days ago

GCPExcelClinical TrialsFDA RegulatoryPharmacovigilanceCommunicationCollaborationWritingMicrosoft OfficeSharePoint

About the role

As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.
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.

Develop and implement quality assurance plans and strategies for clinical studies and related activities
Assess audit findings and develop corrective and preventative actions (CAPA)
Lead investigations into quality issues and deviations, identifying root causes and implementing appropriate CAPA
Collaborate with cross-functional teams to support data integrity during audits, inspections and clinical trial activities by adhering to GxPs standards and applicable regulations governing clinical data
Review and approve GCP/GVP-related documentation, including study protocols, study reports, and other relevant documents
Facilitate/participate in Quality Oversight Committee meetings with Vendors and develop and maintain quality agreements with Vendors

Minimum of 10 or more 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
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
Proficiency in Microsoft Word, Power Point, Excel, Adobe, and SharePoint
Bachelor's degree 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
Clear, concise writing skills and good verbal communication and presentation skills
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 a professional and collaborative manner

$155,000 - $190,000 USD
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.
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.
This range represents the company's good-faith estimate of the salary at the time of posting.

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.
Develop and implement inspection readiness plans and procedures, ensuring that clinical studies and related activities are ready for Health Authority inspections
Provide guidance and support to cross-functional teams during Health Authority inspections

We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence.

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

tive 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-rel

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