Director, Quality GxP Systems
Beeline Medicines, Boston, MA, United States
Job Summary
The Director, Quality Systems is a senior leader responsible for establishing, maintaining, and continuously improving the enterprise Quality Management System (QMS) in alignment with global regulatory requirements and industry best practices for a clinical-stage biotechnology company. This role serves as the functional owner of core quality system processes—including document control, change control, CAPA, audit management, and training—and plays a critical part in building the quality infrastructure needed to support a lupus and immunology/inflammation pipeline through clinical development and toward regulatory submission. The Director will partner cross‑functionally with Clinical, CMC, Regulatory, and Medical Affairs teams to ensure quality systems are fit‑for‑purpose, inspection‑ready, and scalable as the organization grows. This is a high‑visibility, hands‑on leadership role that requires both strategic vision and operational rigor.
Work Arrangement & Location Hybrid – This position follows a hybrid work schedule, requiring a minimum of two (2) days on‑site per week – currently designated as Tuesday and Wednesday. Additional on‑site days may be required based on business needs, team priorities, or leadership direction.
Essential Duties And Responsibilities
Design, implement, and own the end‑to‑end Quality Management System (QMS), ensuring alignment with ICH Q10, 21 CFR Parts 11, 210/211, and applicable international regulatory frameworks.
Serve as the process owner for critical quality system elements including document control, change control, deviation/CAPA management, audit readiness, and GxP training programs.
Lead and execute the internal audit program, including risk‑based audit scheduling, facilitation of audit activities across functional areas, and oversight of CAPA closure and effectiveness checks.
Establish and maintain robust document management infrastructure, including SOP lifecycle governance, controlled document repositories, and version control standards across the organization.
Develop and maintain quality metrics, KPIs, and management review reporting frameworks that provide leadership with visibility into system health, compliance risk, and continuous improvement trends.
Partner with Regulatory Affairs to support IND, BLA, and MAA submissions by ensuring quality system documentation and compliance data are accurate, current, and audit‑ready.
Represent quality systems in regulatory agency inspections and health authority interactions; serve as a subject‑matter expert during pre‑approval inspections and for‑cause audits.
Collaborate with CMC Technical Operations, Clinical Development, and Medical Affairs to embed quality system requirements into functional workflows and ensure GxP compliance across all development activities.
Drive the selection, implementation, and optimization of quality management technology platforms (e.g., eQMS), ensuring system validation, user adoption, and ongoing governance.
Build and develop a high‑performing quality systems team; define organizational structure, set performance expectations, and create a culture of accountability, continuous improvement, and compliance excellence.
Perform other duties and responsibilities as assigned.
Qualifications
Education: Bachelor’s degree required in a scientific or technical discipline (Life Sciences, Chemistry, Engineering, or related field); advanced degree strongly preferred.
Minimum of 10 years of progressive quality experience in the pharmaceutical or biotechnology industry.
3 years in a leadership role with direct oversight of quality systems functions.
Deep working knowledge of GxP regulations, including FDA 21 CFR Parts 210/211, ICH Q8–Q12 guidelines, EU GMP Annex requirements, and computer system validation under 21 CFR Part 11.
Demonstrated experience designing and implementing enterprise QMS platforms and managing all associated system elements (CAPA, change control, document control, deviations, training) in a regulated biopharmaceutical environment.
Experience with eQMS platform implementation (e.g., Veeva Vault QMS, MasterControl, or equivalent); familiarity with system validation protocols and electronic record requirements.
Skilled at influencing without authority; effectively engages senior scientific, clinical, and operational stakeholders to drive alignment on quality priorities and shared accountability for compliance.
Able to serve as a primary quality representative in regulatory agency interactions and inspections, communicating the company’s quality posture with confidence and credibility.
Strong cross‑functional collaborator who proactively communicates quality risk, escalates issues with appropriate context and urgency, and fosters a culture of transparent, solution‑oriented dialogue.
Salary Range The expected annual salary range for this position is $210,000 – $230,000 USD. Actual pay will be determined based on experience, qualifications, location, and other job‑related factors permitted by law. A discretionary annual bonus and long‑term incentive award (e.g., equity) may be available based on individual and company performance.
Benefits
Medical, Dental & Vision insurance (employee premiums 100% covered by company)
20 accrued days combined time off (PTO/Sick), 12 company holidays, and winter recharge
Flexible work arrangements / hybrid schedule
Health Savings Account (HSA)
Benefits are subject to eligibility requirements and plan terms. Additional details provided during the offer process.
Equal Employment Opportunity Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
Reasonable Accommodation If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.
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Work Arrangement & Location Hybrid – This position follows a hybrid work schedule, requiring a minimum of two (2) days on‑site per week – currently designated as Tuesday and Wednesday. Additional on‑site days may be required based on business needs, team priorities, or leadership direction.
Essential Duties And Responsibilities
Design, implement, and own the end‑to‑end Quality Management System (QMS), ensuring alignment with ICH Q10, 21 CFR Parts 11, 210/211, and applicable international regulatory frameworks.
Serve as the process owner for critical quality system elements including document control, change control, deviation/CAPA management, audit readiness, and GxP training programs.
Lead and execute the internal audit program, including risk‑based audit scheduling, facilitation of audit activities across functional areas, and oversight of CAPA closure and effectiveness checks.
Establish and maintain robust document management infrastructure, including SOP lifecycle governance, controlled document repositories, and version control standards across the organization.
Develop and maintain quality metrics, KPIs, and management review reporting frameworks that provide leadership with visibility into system health, compliance risk, and continuous improvement trends.
Partner with Regulatory Affairs to support IND, BLA, and MAA submissions by ensuring quality system documentation and compliance data are accurate, current, and audit‑ready.
Represent quality systems in regulatory agency inspections and health authority interactions; serve as a subject‑matter expert during pre‑approval inspections and for‑cause audits.
Collaborate with CMC Technical Operations, Clinical Development, and Medical Affairs to embed quality system requirements into functional workflows and ensure GxP compliance across all development activities.
Drive the selection, implementation, and optimization of quality management technology platforms (e.g., eQMS), ensuring system validation, user adoption, and ongoing governance.
Build and develop a high‑performing quality systems team; define organizational structure, set performance expectations, and create a culture of accountability, continuous improvement, and compliance excellence.
Perform other duties and responsibilities as assigned.
Qualifications
Education: Bachelor’s degree required in a scientific or technical discipline (Life Sciences, Chemistry, Engineering, or related field); advanced degree strongly preferred.
Minimum of 10 years of progressive quality experience in the pharmaceutical or biotechnology industry.
3 years in a leadership role with direct oversight of quality systems functions.
Deep working knowledge of GxP regulations, including FDA 21 CFR Parts 210/211, ICH Q8–Q12 guidelines, EU GMP Annex requirements, and computer system validation under 21 CFR Part 11.
Demonstrated experience designing and implementing enterprise QMS platforms and managing all associated system elements (CAPA, change control, document control, deviations, training) in a regulated biopharmaceutical environment.
Experience with eQMS platform implementation (e.g., Veeva Vault QMS, MasterControl, or equivalent); familiarity with system validation protocols and electronic record requirements.
Skilled at influencing without authority; effectively engages senior scientific, clinical, and operational stakeholders to drive alignment on quality priorities and shared accountability for compliance.
Able to serve as a primary quality representative in regulatory agency interactions and inspections, communicating the company’s quality posture with confidence and credibility.
Strong cross‑functional collaborator who proactively communicates quality risk, escalates issues with appropriate context and urgency, and fosters a culture of transparent, solution‑oriented dialogue.
Salary Range The expected annual salary range for this position is $210,000 – $230,000 USD. Actual pay will be determined based on experience, qualifications, location, and other job‑related factors permitted by law. A discretionary annual bonus and long‑term incentive award (e.g., equity) may be available based on individual and company performance.
Benefits
Medical, Dental & Vision insurance (employee premiums 100% covered by company)
20 accrued days combined time off (PTO/Sick), 12 company holidays, and winter recharge
Flexible work arrangements / hybrid schedule
Health Savings Account (HSA)
Benefits are subject to eligibility requirements and plan terms. Additional details provided during the offer process.
Equal Employment Opportunity Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
Reasonable Accommodation If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.
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