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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 function.
Ensure appropriate quality oversight of external vendors.
Active member of GMP vendor meetings.
Review and approve vendor GMP documentation.
Review and approve vendor and Kailera GMP quality events.
Review and approve executed batch records for associated regulatory standard materials, intermediates, and drug substance for Kailera's program and determine final batch disposition.
Support creation of adherence to vendor quality agreements.
Generate metrics and compile data for quality system reviews.
Participate in Kailera GMP sub-teams as the quality representative.
Evaluate GMP activities for continuous improvement opportunities to the Kailera quality system.
Support creation and continuous improvement of Kailera procedures.
Coordinate and manage compliance related activities in preparation for health authority inspections and support interactions during health authority inspections.
Other quality assurance responsibilities as assigned.

Required Qualifications:

8+ years of experience in an FDA regulated pharmaceutical industry with GMP experience.
Extensive 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 assurance.
Experience with health authority filings and/or inspections.
Proficient in Veeva QualityDocs and Veeva QMS.
Demonstrates proven track record of leadership, communication, and motivation skills with internal and external vendors.
A strong team player with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations, and business needs.
Provide solutions to issues. Solutions are imaginative, thorough, practical, and consistent with objectives.
Solves conflict and addresses workplace issues in professional and collaborative manner.
Flexibility/ability to provide a solution-based approach to emerging challenges/changing priorities.
Clear, concise writing skills and good verbal presentation skills.
Self-motivated, detail oriented, well organized, and able to demonstrate success with managing multiple projects simultaneously and other priorities.
Ability to interact constructively and efficiently with co-workers within and across departments and management, as well as with vendors.
Communicate decisions and recommendations with clear justification.
Ability to resolve day-to-day issues efficiently while maintaining compliance.
Independently determines and develops approach to solutions.
Proactive approach to problem solving.

Preferred Qualifications:

Biotech experience preferred.

Education:

BA or BS degree in a scientific discipline or supplemental quality education.

Benefits of Working at Kailera:

In 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 accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance

At 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 USD

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.

","

Associate Director, Gmp Quality Assurance (Drug Substance)

At Kailera, we are bold, authentic and committed to our mission of developin...","Associate Director, GMP Quality Assurance (Drug Substance)NewWaltham, Massachuse",["B","2619376980"],"5 days ago","/jobs/2619376980-associate-director-gmp-quality-assurance-drug-substancenewwaltham-massachuse","Associate Director, GMP Quality Assurance (Drug Substance)NewWalt...","/jobs?keyword=Associate+Director%2C+GMP+Quality+Assurance+%28Drug+Substance%29NewWalt...",{"_429":428,"_434":532,"_452":453,"_444":514,"_243":533,"_441":534,"_427":428,"_111":535,"_431":194,"_433":194,"_454":453,"_442":467,"_425":536,"_455":517,"_430":115,"_476":537,"_460":538,"_478":535,"_479":467,"_481":519,"_483":539,"_485":540},["D",1771476171000],"A biopharmaceutical company is seeking a Director of Biostatistics in Waltham, MA. The role involves leading statistical support for clinical studies, ensuring compliance with regulatory requirements, and adopting innovative statistical methodologies. Candidates should have a PhD/MS in Biostatistics or Statistics with substantial experience in regulatory submissions and strong leadership skills. The position offers a competitive salary and a range of comprehensive benefits to support employee well-being.
#J-18808-Ljbffr","A biopharmaceutical company is seeking a Director of Biostatistics in Waltham, MA. The role involves leading statistical support for clinical studi...","Director of Biostatistics — Strategic Trial Analytics Lead",["B","2625565564"],"2 hours ago","/jobs/2625565564-director-of-biostatistics-strategic-trial-analytics-lead","/jobs?location=Waltham","/jobs?keyword=Director+of+Biostatistics+%E2%80%94+Strategic+Trial+Analytics+Lead",{"_429":428,"_434":542,"_452":453,"_444":514,"_243":543,"_441":544,"_427":428,"_111":545,"_431":194,"_433":194,"_454":453,"_442":467,"_425":546,"_455":517,"_430":115,"_476":537,"_460":547,"_478":545,"_479":467,"_481":519,"_483":539,"_485":548},["D",1771476157000],"

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:

As the Director of Biostatistics, you will lead statistical support for both early- and late-phase clinical studies, ensuring that statistical strategies and methodologies align with clinical development objectives and regulatory expectations. In this critical role, you will lead the development, execution, and interpretation of statistical analyses, ensuring data quality, analysis integrity, and compliance with regulatory standards. This role requires strong statistical and cross‑functional leadership to influence clinical development strategy and decision‑making, directly contributing to the success of the company’s goals.

Required location: Waltham, MA (hub‑based, onsite 3‑4 days per week)

Responsibilities:

Lead statistical efforts for early‑to‑late phase clinical studies, key regulatory, and submission activities
Provide statistical leadership in the development and execution of clinical development strategies by collaborating with cross‑functional teams
Lead the development and the adoption of innovative statistical approaches (e.g., adaptive, seamless, Bayesian designs) to enhance trial efficiency, optimize resource utilization, and increase the probability of success
Ensure the accuracy, integrity, and consistency of statistical analyses across all clinical development programs, from Phase I through regulatory submissions and post‑approval activities
Oversee CRO activities, ensuring quality deliverables, adherence to timelines, and efficient resource utilization

Required Qualifications:

Advanced degree (PhD/MS) in Biostatistics or Statistics
- PhD : Minimum of 8+ years of relevant experience
- MS : Minimum of 10+ years of relevant experience
Successful experience in regulatory submissions, including NDAs, BLAs, and other filings
Strong leadership in statistical activities supporting clinical development programs
Participated in implementing innovative statistical methodologies to enhance clinical trial efficiency and effectiveness
Hands‑on expertise with statistical software (e.g., SAS, R) and familiarity with CDISC standards
Strong problem‑solving and strategic thinking skills, with the ability to translate complex statistical concepts into actionable insights for diverse stakeholders
Excellent communication and interpersonal skills, with the ability to influence decision‑making and foster collaboration across functions
Extensive leadership experience in overseeing CRO activities

Education:

PhD/MS in Biostatistics or Statistics

Salary Range

$175,000 - $230,000 USD

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.

#J-18808-Ljbffr","

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives a...","Director, Biostatistics",["B","1981938408"],"/jobs/1981938408-director-biostatistics","/jobs?keyword=Director%2C+Biostatistics",{"_429":428,"_434":550,"_452":453,"_444":551,"_243":438,"_441":438,"_427":428,"_111":552,"_431":432,"_433":194,"_454":453,"_442":443,"_425":553,"_455":554,"_430":115,"_476":555,"_460":556,"_478":552,"_479":443,"_481":557,"_483":484,"_485":558},["D",1771200000000],"Dyne Therapeutics Inc","Senior Director, DMD Scientific and Medical Education Lead",["B","2619506123"],"Work at Dyne Therapeutics Inc","3 days ago","/jobs/2619506123-senior-director-dmd-scientific-and-medical-education-lead","/jobs?keyword=Dyne+Therapeutics+Inc","/jobs?keyword=Senior+Director%2C+DMD+Scientific+and+Medical+Education+Lead","actionData","errors"]