Director, Analytical Development and Quality Control Job at Kailera Therapeutics (Waltham, Massachusetts)

Associate Director, Analytical Development and Quality Control

The Associate Director, Analytical Development and Quality Control will support ...

Location

United States , San Diego

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

10+ years of experience, or 5+ with advanced degree, in the pharmaceutical/biotech industry with experience in all phases of innovative drug development and commercial launch in accordance with global CMC regulatory filings (IND/NDA/MAA, etc.)
Strong expertise in analytical techniques HPLC/UPLC, LC–MS, SE-HPLC, dissolution, along with extractables and leachable analysis
Knowledge of drug development activities with respect to cGMP, quality systems, ICH guidelines, global regulatory requirements, and USP, EP, JP, and CHP requirements
Hands-on experience supporting early- and late-stage CMC development, stability programs, and specification setting
Proven experience leading OOS/OOT investigations, deviations, CAPAs, and change controls
Strong track record of working with CROs/CMOs and managing external analytical/testing activities
Excellent technical writing skills for analytical reports and regulatory submissions (IND/IMPD, NDA/BLA)
Demonstrated leadership ability with experience mentoring and developing scientific staff
Strong communication, cross-functional collaboration, and project-management skills
Innovative team-player with high energy for our dynamic company environment

Job Responsibility

Support analytical development and QC activities related to characterization of drug substances and drug products from early-stage clinical development through commercialization
Maintain current knowledge in analytical methods and control strategies supporting a variety of molecule platforms and dosage forms
Oversee and provide scientific leadership on QC testing for DS/DP at vendors, ensuring cGMP compliance, data integrity, and timely delivery of analytical results
Direct investigations including OOS/OOT, deviations, and CAPAs, and provide strong analytical rationale
Design and manage stability programs (accelerated, long-term, bracketing/matrixing) supporting early and late clinical phases
Interpret stability trends and establish shelf-life/retest periods consistent with ICH guidelines and peptide behavior
Support comparability assessments for process changes, analytical method updates, or site transfers
Communicate CMC project status to key stakeholders cross-functionally and assist in driving decision-making
Participate in cross-functional CMC teams for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies as needed
Author and review CMC sections of IND/IMPD and NDA submissions and address regulatory questions

What we offer

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

Fulltime

Deputy Director of Quality Assurance and Quality Control

This position provides a high level of responsible, complex management and polic...

Location

United States , Honolulu

Salary:

120900.00 - 193490.00 USD / Year

Honolulu

Expiration Date

Until further notice

Requirements

A combination of education and experience substantially equivalent to graduation from an accredited college or university with major work in quality management, business administration, engineering, or a related field
five years of progressive experience in quality assurance, quality control, or related administrative or analytical field
experience must include active involvement in developing, implementing, improving QA/QC processes or programs, with demonstrated ability to analyze operations and develop effective solutions
a minimum of two years experience in a governmental agency or regulated industry, including experience supervising or managing QA/QC activities or teams
candidate must meet the health and physical condition standards necessary and proper for performing the essential duties

Job Responsibility

Assist, establish, implement, and maintain an effective Quality Management Plan for HART, including methods to investigate, monitor, regulate, and enforce quality standards
establish coordination of functions and operations across departments through the development and clear definition of quality assurance procedures
ensure HART’s compliance with applicable laws, regulations, rules, and generally accepted industry practices
provide additional oversight for the planning, analysis, inspection, design, testing, and/or integration of products and/or components to ensure compliance with HART’s quality assurance program
contribute to the development of contractor and quality specifications for design, procurement, and construction contracts
oversee internal and external audit, surveillance, and monitoring programs, ensuring compliance with HART's requirements
holds the delegated responsibility for ensuring that internal and external audits are scheduled, performed, and followed up
review HART’s activities, including contract work performed
help to identify and evaluate quality issues or work deficiencies, and initiate, recommend, or implement solutions and procedural changes as needed
guide and direct other quality assurance functions, including the conduct of quality engineering reviews of design plans, specifications, procedures, contracts, and request for proposals, for completeness and quality requirements

What we offer

Medical, prescription drug, vision, dental, and life insurance plans
generous vacation and sick leave, earning up to 21 days per year
13 paid holidays annually (14 days during election year)
retirement plan contributions through the Employees' Retirement System (ERS)
deferred compensation options to invest pre-tax income for retirement
flexible spending accounts for health and dependent care expenses
pre-tax transportation benefits, including TheBus and vanpool options
access to confidential counseling services through the Employee Assistance Program (EAP)
additional perks include training opportunities and employer-funded Holo Card for eligible employees to use on public transit
eligibility for Public Service Loan Forgiveness (PSLF) program, supporting employees dedicated to public service

Fulltime

Senior Director, Quality Control Analytical Sciences

We are seeking a Senior Director, Quality Control (QC) Analytical Sciences, to l...

Location

Salary:

245000.00 - 260000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

PhD in relevant discipline (e.g., analytical biochemistry or relevant field)
15+ years of QC experience with complex biologics, particularly monoclonal antibodies, spanning late-stage development and commercialization
Proven people leader with a growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment
Excellent communicator with an ability to present to and be understood by a variety of stakeholders and tailor message accordingly
Experience with regulatory filing preparation and messaging across global jurisdictions
Deep knowledge and understanding of relevant global regulatory guidance and requirements
Ability to keep pace with a fast-moving organization
Availability to participate in calls across multiple international time zones
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
Ability and willingness to travel up to 30%

Job Responsibility

Lead QC Analytical Sciences team, responsible for QC activities for all pipeline programs including strategies for phase-appropriate method qualification, validation, and transfer for drug substance, drug product, and drug-device combination testing
in-process/release/stability testing
specification justification and maintenance
shelf-life management
and critical documentation
Partner with new and existing external QC testing labs and CDMOs, managing relationships and all relevant activities in collaboration with TechOps Program Management, Quality Assurance, and Manufacturing
Develop analytical regulatory strategies and prepare relevant Module 3 regulatory documents
Contribute to a mature QC infrastructure, implementing processes and procedures to support the development of therapeutic candidates in a GMP-compliant manner
Monitor data trends, troubleshoot QC method performance, and investigate OOT/OOS results

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Senior Director, Analytical Development and Quality Control

The Altos Institute of Medicine will capture knowledge generated about cell heal...

Location

United States , Redwood City

Salary:

283900.00 - 384100.00 USD / Year

Altos Labs

Expiration Date

Until further notice

Requirements

Ph.D. in analytical sciences or biological sciences
Minimum 15+ years of analytical development and QC experience in biotech/pharmaceutical industry
10+ years of Management experience
Highly experienced in developing and implementing assays for Quality Control testing and characterization of drug substance, drug product and manufacturing in-process samples
Experienced in multiple modalities including biologics, oligonucleotides, small molecules, mRNA/LNP and AAV gene therapy
Experienced in leading CMC team and analytical subteam
Proficient in cGMP’s and pharmaceutical industry procedures and regulations
Highly experienced in achieving CMC deliverables through outsourcing to Contract Manufacturing Organizations
Leadership experience in managing diverse project activities with contract CDMO facilities at global locations
A critical thinker with the ability to analyze possibilities and solutions and make pragmatic trade-offs

Job Responsibility

Lead analytical development and quality control across multiple modalities
Build a high performing team and establish internal and external analytical and QC capabilities
Serve as CMC lead and analytical lead for Altos therapeutic programs
Manage contract manufacturing organizations and CROs to develop and qualify analytical testing methods, perform product characterization, release and stability testing, and in-process testing
Establish product specifications to ensure product quality
Support technical assessment of Out of Specification and Non-Conforming investigations
Author, review, and/or approve Standard Operating Procedures, specifications, regulatory filing, or other controlled documents
As a member of the Tech Ops leadership team, build the Tech Ops organization, processes, systems and infrastructure
Create and foster strong partnerships with Institutes of Science, Institutes of Technology, Institute of Computation, drug discovery and development sciences, clinical, regulatory, program management, business development, legal and finance
Actively contribute to a team culture that promotes continuous improvement, accountability, professional growth, and inclusion

Fulltime

Sr. Director, QC Analytical Methods

The Sr. Director, Quality Control, Analytical Methods will provide strategic lea...

Location

United States , Durham

Salary:

250000.00 - 310000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s or advanced degree in scientific discipline
Minimum of 18 years’ experience in the pharmaceutical/biotech industry, encompassing drug substance/drug product manufacturing, development, and/or quality
Direct experience with cell and/or gene therapy programs is strongly preferred
Experience with implementing, validating, and overseeing execution of automated test methods
Proven experience leading teams in Quality and Quality Control functions
Demonstrated support for all phases of a program’s lifecycle (pre-IND through commercial lifecycle management)
At least 10 years of Quality management experience
Exceptional verbal and written communication skills, with a detail-oriented approach and the ability to drive change across functions
Experience engaging with regulatory health authorities during pre- and post-approval inspections
In-depth knowledge of global regulations and standards

Job Responsibility

Deliver comprehensive Quality Control leadership across multiple programs and cross-functional forums
Develop and implement robust QC strategies for method qualification, transfer, and validation in collaboration with Analytical Development and other key stakeholders
Provide strategic direction to Quality Control teams in North Carolina and Massachusetts, ensuring excellence in method lifecycle management and product quality testing and stability
Serve as a QC leader in interactions with Beam’s suppliers and the internal manufacturing site in Durham, North Carolina
Establish and monitor metrics for all testing aspects, including in-process, release, stability testing, and OOT/OOS results
Partner with Quality Assurance to ensure contract laboratory service providers are appropriately qualified and that Quality Agreements are comprehensive, approved, and regularly updated
Ensure strict adherence to GMP principles within internal and external laboratories
Maintain compliance of quality control systems and equipment with all applicable regulatory guidelines, upholding data integrity to ensure confidence in generated data
Track and analyze GMP data, including the evaluation and approval of data from external contract laboratories
Compile and present data with insightful interpretations for management reviews, Annual Product Reviews, and other required assessments

Fulltime

Director of Quality

As the Director of Quality, you will be responsible for leading operational qual...

Location

United States , Union City

Salary:

216481.00 - 237601.00 USD / Year

BillionToOne

Expiration Date

Until further notice

Requirements

8+ years quality leadership experience in a CLIA-certified laboratory environment with demonstrated ability to lead and manage people and teams
Deep understanding of CLIA, CAP, state laboratory regulations (including NYS Clinical Lab requirements)
Proven track record of successfully reducing quality issues through systematic improvement initiatives
Hands-on experience with supplier quality management, including qualification, auditing, and corrective action management
Experience implementing or optimizing quality processes in a regulated laboratory setting
Strong analytical skills with ability to analyze quality data, identify trends, and develop data-driven solutions
Demonstrated ability to work cross-functionally and influence without direct authority
Ability to work independently and cross-functionally to provide effective updates at executive level
Detail-oriented with well-developed organizational and problem-solving skills
Proven ability to communicate effectively both in writing and verbally with staff at all levels

Job Responsibility

Lead and execute operational quality programs including incident management, material management, supplier management, trending/monitoring, and compliance
Drive continuous improvement initiatives by conducting root cause analyses, implementing corrective actions, and optimizing processes to reduce nonconformances and enhance laboratory efficiency
Partner directly with Lab Operations, Supply Chain, R&D, and other stakeholders to solve problems and embed quality into daily workflows
Serve as subject matter expert for operational quality matters
personally lead critical investigations and improvement projects as needed
Driving systematic reduction of quality issues through root cause analysis, trend identification, and implementation of sustainable corrective actions
Establishing and tracking operational quality metrics (NCR, CAPA, Change Control, Preventive Maintenance, etc.) to drive data-driven decision making
Developing risk-based receiving inspection protocols that balance quality assurance with operational efficiency
Establishing acceptance criteria and sampling plans for incoming materials, reagents, and consumables
Ensuring laboratory quality systems operate effectively to support daily operations

What we offer

Working alongside brilliant, kind, passionate and dedicated colleagues, in an empowering environment, toward a global vision, striving for a future in which transformative molecular diagnostics can help millions of patients
Open, transparent culture that includes weekly Town Hall meetings
The ability to indirectly or directly change the lives of hundreds of thousands patients
Multiple medical benefit options
employee premiums paid 100% of select plans, dependents covered up to 80%
Extremely generous Family Bonding Leave for new parents (16 weeks, paid at 100%)
Supplemental fertility benefits coverage
Retirement savings program including a 4% Company match
Increase paid time off with increased tenure
Latest and greatest hardware (laptop, lab equipment, facilities)

Fulltime

Deputy Director - Quality (Medical Coding)

We are seeking an experienced Medical Coding leader to join our team in Chennai ...

Location

India , Chennai

Salary:

Not provided

Access Healthcare LLC

Expiration Date

Until further notice

Requirements

Deep understanding of medical coding standards and audit processes
Experience with automation and AI solutions in coding audits
Proficiency in developing and managing quality metrics dashboards
Strategic leadership and ability to influence cross-functional teams
Strong problem-solving and decision-making capabilities
Excellent communication and stakeholder management skills
Minimum 13 years of experience in Healthcare Revenue Cycle Management (RCM) and Quality Assurance
At least 5 to 6 years of core multispecialty coding expertise
Certified Six Sigma Black Belt/Master Black Belt from recognized institutions (e.g., ISI, ASQ, Benchmark, KPMG) with proven project experience
Expertise in coding audit frameworks, accuracy improvement strategies, and regulatory compliance

Job Responsibility

Oversee comprehensive quality audits for coding across in-house teams and multiple vendors
Enforce coding best practices to mitigate risks such as missed diagnoses, over-coding, or under-coding
Drive external and internal audit programs aimed at improving compliance and accuracy
Design and elevate quality control frameworks to ensure coding accuracy and operational efficiency
Lead initiatives to reduce error rates, enhance coding precision, and boost productivity
Implement cutting-edge, AI-enabled audit solutions such as automated coding reviews and real-time QA tools
Monitor and report on Accuracy KPIs, including Missed Error Rate, Extra Error Rate, and Inter-Rater Reliability
Utilize robust data analytics to assess trends in coding accuracy and identify compliance risks
Develop executive dashboards and reports to provide insights into quality performance metrics
Partner with Operations and Training teams to address and resolve coding discrepancies while implementing corrective action plans

Audit Director, Quality & Compliance

The Audit Director is responsible for leading the strategy, execution, and conti...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Life Sciences, Quality, Regulatory, or related discipline
10+ years of GxP audit experience in biotechnology, pharmaceutical, or cell therapy environment
Demonstrated experience leading internal and external GxP audits
Strong understanding of FDA, EMA, MHRA, and ICH regulations (including ICH E6 R3, Annex 1, 21 CFR Parts 210/211/312/820, GCP/GMP/GLP)
Experience supervising or mentoring employees
Strong analytical, organizational, and communication skills
Ability to manage competing priorities in a fast-paced, rapidly growing company
Experience in advanced therapies, ATMPs, or cell/gene therapy manufacturing preferred
Experience preparing for and supporting regulatory inspections preferred
Certifications such as ASQ, RQAP-GCP/GMP, RAC, CQA, or equivalent preferred

Job Responsibility

Develop and maintain the annual risk-based Internal Audit Program across GCP, GMP, GLP, IT/CSV, and Quality Management System (QMS) domains
Plan, schedule, and execute internal audits, vendor audits, and for-cause audits
Ensure alignment with global regulatory requirements and industry best practices for advanced therapies and cell therapy manufacturing
Evaluate organizational risk and adjust audit scope and approach accordingly
Directly supervise the current audit team member including goal setting, workload planning, performance management, and professional development
Provide coaching, technical training, and oversight to ensure audit readiness and consistent application of audit standards
Support team succession planning and capability building as the audit function grows
Lead or oversee audits of internal functional areas (e.g., Clinical Operations, CMC, MSAT, Manufacturing, Quality Control, Regulatory Affairs, IT)
Oversee vendor and third-party audits to qualify and maintain GxP suppliers
Ensure timely issuance of audit reports, management responses, and CAPA plans

What we offer

health and retirement, PTO, and stock option plans

Director, Analytical Development and Quality Control

Kailera Therapeutics

Location:
United States , Waltham, Massachusetts ▼
San Diego, California

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 06, 2026

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