Kailera Therapeutics, Inc.

Senior Specialist, GMP Quality Assurance

Waltham, Massachusetts · Senior · Full-time

Sponsorship not specified$122k-$150kDetected 15 days ago

Clinical TrialsGMPFDA RegulatoryCommunicationWriting

About the role

As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.
As needed, work with external Approved Service Providers to ensure oversight and compliance.
Actual pay may vary based on experience, skills, qualifications, location, and internal equity.

The Senior Specialist, GMP Quality Assurance will collaborate internally with QA, RA, and CMC departments.
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.
Support creation and continuous improvement of Kailera procedures

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
Demonstrates proven track record of communication with internal and external Service providers
Ability to identify quality issues requiring escalation
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

Biotech experience preferred
Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
Proficient in Veeva QualityDocs and Veeva QMS a plus

$122,000 - $150,000 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.
We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown.
BA or BS degree in a scientific discipline or supplemental Quality education

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.

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

This listing is sourced directly from Kailera Therapeutics, Inc.'s careers page and normalized into a canonical job model.