Associate Director, GMP Quality Assurance (Drug Substance)

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 Associate Director will collaborate with the CMC department and external approved vendors to ensure oversight and compliance. The Associate Director will manage GMP activities related to regulatory standard materials, intermediates, and drug substance. The Associate Director will help develop, continuously improve, and maintain quality systems related to GMP activities, maintain documentation for compliance with quality and regulatory standards, and will collaborate closely with internal cross-functional teams and management. The Associate Director will report to the Head of Quality Assurance.Preferred location: Waltham, MA or San Diego, CA (onsite or hybrid 2-3 days per week).Responsibilities:Plan and oversee day-to-day GMP activities of the quality functionEnsure appropriate quality oversight of external vendorsActive member of GMP vendor meetingsReview and approve vendor GMP documentationReview and approve vendor and Kailera GMP quality eventsReview and approve executed batch records for associated regulatory standard materials, intermediates, and drug substance for Kailera's program and determine final batch dispositionSupport creation of adherence to vendor quality agreementsGenerate metrics and compile data for quality system reviewsParticipate in Kailera GMP sub-teams as the quality representativeEvaluate GMP activities for continuous improvement opportunities to the Kailera quality systemSupport creation and continuous improvement of Kailera proceduresCoordinate and manage compliance related activities in preparation for health authority inspections and support interactions during health authority inspectionsOther quality assurance responsibilities as assignedRequired Qualifications:10+ years of experience in an FDA regulated pharmaceutical industry with GMP experienceExtensive understanding and knowledge of industry standards, concepts and current cGMP (21 CFR Parts 210 & 211 & Part 11 and EudraLex) and other agency standards and guidance as they relate to quality systems/quality assuranceExperience with health authority filings and/or inspectionsProficient in Veeva QualityDocs and Veeva QMSDemonstrates proven track record of leadership, communication, and motivation skills with internal and external vendorsA strong team player with the ability to effectively communicate sound, quality advice cross-functionally based on experience, regulations, and business needsProvide solutions to issues. Solutions are imaginative, thorough, practical, and consistent with objectivesSolves conflict and addresses workplace issues in professional and collaborative mannerFlexibility/ability to provide a solution-based approach to emerging challenges/changing prioritiesClear, concise writing skills and good verbal presentation skillsSelf-motivated, detail oriented, well organized, and able to demonstrate success with managing multiple projects simultaneously and other prioritiesAbility to interact constructively and efficiently with co-workers, within and across departments, and management, as well as with vendorsCommunicate decisions and recommendations with clear justificationAbility to resolve day-to-day issues efficiently while maintaining complianceIndependently determines and develops approach to solutionsProactive approach to problem solvingPreferred Qualifications:Biotech experience preferred.Education:BA or BS degree in a scientific discipline or supplemental quality education.Benefits of Working at KaileraIn addition to traditional benefits, we provide enhanced offerings designed to support the well-being and financial security of our team members and their families.Comprehensive health benefits and tax-advantaged savings accountsFlexible time off, 13 paid holidays, and a companywide year-end shutdownMonthly wellness stipendGenerous 401(k) matchDisability and life insuranceAt Kailera, we are committed to fostering an inclusive culture. How we treat our people is reflective of this commitment. We share the pay range for this particular role with the actual base salary depending upon factors such as job-related knowledge, skills, market factors, and experience.Salary Range$160,000-$200,000 USDEQUAL 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. #LI-Hybrid