Director/Senior Director, Quality Assurance
Azalea Therapeutics · Berkeley, CA · 3 wk ago
Quality AssuranceFull-time
We need to output HTML fragment with sections: About the role? Actually we have sections: About Azalea (company description), How We Work (culture), The Opportunity (role description), Key Responsibilities, Qualifications (Minimum and Preferred), What Success Looks Like (first 3–6 months), Working Conditions / Physical Requirements, Compensation And Benefits. Also maybe "About Azalea" is a section heading? The instruction: use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). They gave examples but we can use appropriate headings based on content. Should not repeat job title as heading. Should not include Job ID etc. Remove boilerplate like EEO, accommodation, privacy, disclaimer, recruiter notice, fraud warning. Also remove duplicated lines. Keep all substantive info.
We need to decide which sections to include: Must have real specific content. We have:
- About Azalea (company description) – yes.
- How We Work (culture values) – yes.
- The Opportunity (role overview) – yes.
- Key Responsibilities – yes.
- Qualifications – we have Minimum Qualifications and Preferred Qualifications. Could combine into Qualifications section with subpoints? Probably just Qualifications.
- What Success Looks Like (first 3–6 months) – could be a section like "Early Objectives" or "Success Metrics". Use heading maybe "What Success Looks Like (first 3–6 months)".
- Working Conditions / Physical Requirements – yes.
- Compensation And Benefits – yes (salary range, bonus, equity, benefits).
We should not include Pay/Schedule/Benefits unless posting actually states them. It does state salary range, bonus/equity eligibility, benefits. So we can include Compensation and Benefits.
We should not include sections like "Skills" unless present. Not needed.
We need to use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). They gave examples but we can use appropriate headings based on content. Should not repeat job title as heading. Should not include Job ID etc. Remove boilerplate like EEO, accommodation, privacy, disclaimer, recruiter notice, fraud warning. Also remove duplicated lines. Keep all substantive info.
We need to decide which sections to include: Must have real specific content. We have:
- About Azalea (company description) – yes.
- How We Work (culture values) – yes.
- The Opportunity (role overview) – yes.
- Key Responsibilities – yes.
- Qualifications – we have Minimum Qualifications and Preferred Qualifications. Could combine into Qualifications section with subpoints? Probably just Qualifications.
- What Success Looks Like (first 3–6 months) – could be a section like "Early Objectives" or "Success Metrics". Use heading maybe "What Success Looks Like (first 3–6 months)".
- Working Conditions / Physical Requirements – yes.
- Compensation And Benefits – yes (salary range, bonus, equity, benefits).
We should not include Pay/Schedule/Benefits unless posting actually states them. It does state salary range, bonus/equity eligibility, benefits. So we can include Compensation and Benefits.
We should not include sections like "Skills" unless present. Not needed.
We need to use - for any list of duties/requirements/benefits. So for responsibilities, qualifications (maybe list), benefits, etc.
We need to use
for prose.
We must not repeat job title as heading. So no
Director/Senior Director, Quality Assurance
.
We need to output only HTML fragment, no /, no markdown fences.
Let's craft.
Structure:
About Azalea
...
How We Work
...
maybe include list of values? The text includes bullet-like list: Outcome Ownership, Comfort with Ambiguity, High Standards, Low Ego, Collaboration and Candor. Could be - .
The Opportunity
...
Key Responsibilities
- ...
... etc.
Qualifications
We could split into Minimum and Preferred as subheadings? But instruction says use for section headings; we could have Minimum Qualifications
and Preferred Qualifications
as separate sections. That's okay.
But we need to avoid too many thin sections; but it's fine.
Alternatively combine into one Qualifications section with two lists. But we have distinct content; we can do two subheadings ? Not allowed? Only said use for section headings; didn't forbid other headings but better to stick to . Could do Minimum Qualifications
and Preferred Qualifications
.
What Success Looks Like (first 3–6 months)
...
maybe list.
Working Conditions / Physical Requirements
...
Compensation and Benefits
...
maybe list benefits.
We need to preserve all substantive information; do not invent or summarize away detail. So we need to include details like: Azalea Therapeutics is enabling precision genome engineering directly inside the body, with an initial focus on creating cancer immunotherapies in vivo .Azalea is pioneering a new way to turn a person’s own T cells into a powerful cancer therapy — directly inside the body. Instead of removing cells and manipulating them in a lab, we use precision genome editing tools to engineer T cells where they already live. At the center of our approach are Enveloped Delivery Vehicles, or EDVs. As highly selective couriers, EDVs are designed to specifically locate T cells within the patient and deliver our genome engineering cargo. Once inside the cell, the anti-cancer agent is inserted into a precise site in the genome, ensuring safe and potent modifications to fortify the T cells against cancers.
We need to keep that exactly.
Also "Why This Matters" section: We aim to make cell therapy faster and more accessible by avoiding complex manufacturing outside the body. Our platform is designed for precision, so the right cells are safely programmed to effectively fight cancer. This technology has the potential to treat a wide range of cancers with a streamlined, scalable process. Our goal is simple: develop next-generation delivery technologies to bring genetic engineering and cell therapies to more patients.
We should include that as part of About Azalea maybe separate? Could be its own section "Why This Matters". But instruction says include a section only when posting has real specific content. It does. Could add Why This Matters
. However they gave examples of headings but not limited. We can add.
But we need to avoid too many sections; but it's okay.
We also have "How We Work Role" paragraph: "Azalea is building ambitious science in a fast-moving environment..." That's part of How We Work.
We have "The Opportunity" paragraph.
We have "Key Responsibilities" list.
We have "Qualifications" with Minimum and Preferred.
We have "What Success Looks Like (first 3–6 months)" paragraph.
We have "Working Conditions / Physical Requirements": Onsite 2-3 days per week in our Berkeley office Travel up to 25%
We have "Compensation And Benefits": salary range $185,000 - $260,000 per year. Offer amounts determined by factors... Salary will be commensurate with experience... This role is eligible for annual performance bonuses, equity grants, and a comprehensive benefits package that includes medical, dental, vision, retirement plan with company match, and paid time off.
We need to keep that.
We need to remove boilerplate: EEO, Reasonable Accommodation, Applicant Privacy, Job Description Disclaimer, Notice to Recruiters/Staffing Agencies, Information on Fraudulent Job Offers.
Also remove duplicated lines.
Now craft HTML.
We'll need to escape any special characters? Not needed.
Let's write.
We'll start with About Azalea
then ... include the description and maybe also Why This Matters as separate
Why This Matters
...
.
Then How We Work
Azalea is building ambitious science in a fast-moving environment. The people who thrive here are accountable, adaptable, rigorous, humble, and direct. Across roles and functions, we look for team members who demonstrate the following:
then - Outcome Ownership - We own results, close loops, and follow through without needing to be prompted. We take responsibility for moving work forward and making sure important decisions, deliverables, and handoffs do not fall through the cracks.
... etc.
Then The Opportunity
The Director/Senior Director, Quality Assurance will be Azalea’s first dedicated Quality Assurance hire and will build the QA function required to support external manufacturing, GMP readiness, regulatory interactions, and future clinical supply. This is a hands-on leadership role for a Quality Assurance leader who can establish phase-appropriate and right-sized systems in an early-stage company while maintaining rigorous standards for patient safety, data integrity, and regulatory compliance. The role will partner closely with CMC, Process Development, Analytical Development, Regulatory Affairs, Clinical, and CDMO partners and consultants to advance AZA-2509 and pipeline programs toward first-in-human clinical development.
Then Key Responsibilities
with each responsibility as - . Need to capture all bullet points from the posting.
Let's extract responsibilities:
- Build and lead Azalea’s Quality Assurance function, including the quality strategy, operating model, roadmap, and resourcing plan appropriate for an early-stage biotechnology company advancing toward first-in-human studies.
- Establish, implement, and continuously improve a phase-appropriate Quality Management System, including SOPs, document control, training, deviation and CAPA management, change control, risk management, vendor qualification, batch record review, product disposition, audits, complaints, and quality metrics.
- Serve as the QA business partner to CMC, Process Development, Analytical Development, External Manufacturing, Regulatory Affairs, Clinical, and Program Team leaders to ensure quality considerations are embedded into program planning and execution.
- Lead QA oversight of external consultants, CDMOs, testing laboratories, and other GxP vendors, including quality agreements, vendor qualification, audit planning, issue escalation, and ongoing performance management.
- Establish and execute batch release and disposition processes for development, engineering, GMP, and future clinical materials, including review of batch records, deviations, investigations, analytical data packages, certificates of analysis, and supporting documentation.
- Provide QA leadership for EDV and AAV manufacturing and analytics, including phase-appropriate controls for process development, analytical method development, pilot runs, engineering runs, and GMP manufacturing readiness.
- Define and maintain quality requirements for labeling, packaging, and clinical supply documentation, including awareness of requirements that may apply inside and outside the United States.
- Support regulatory strategy and submissions by contributing quality content, reviewing CMC documentation, preparing for health authority interactions, and ensuring commitments are tracked and closed.
- Prepare the organization and work with external partners for audits and inspections by establishing inspection readiness practices, maintaining traceable documentation, and leading response planning for quality observations.
- Develop practical quality risk management approaches that help Azalea make sound decisions in an early-stage environment while protecting patient safety, product quality, and data integrity.
- Translate quality strategy into clear priorities, accountabilities, and decision points; close loops on issues that cross internal functions and external partners.
- As the function grows, recruit, develop, and lead QA team members and consultants, setting expectations for high standards, direct communication, and accountable follow-through.
We need to keep each as
- .
Then
Minimum Qualifications
with each bullet.
Minimum qualifications list:
- 10 + years of progressive Quality Assurance leadership experience in biotechnology, biologics, cell therapy, gene therapy, or another complex modality with manufacturing and external partner oversight.
- Demonstrated experience partnering with CDMOs and external testing laboratories in a GMP environment.
- Proven track record establishing and scaling quality systems, SOPs, quality agreements, vendor oversight practices, and batch release processes in a biotechnology setting.
- Hands-on experience with product batch record review, deviation assessment, CAPA, change control, product disposition, and release documentation.
- Strong working knowledge of applicable GxP expectations and relevant U.S. and international Quality requirements for investigational products, clinical supply, labeling, documentation, and external manufacturing oversight.
- Experience supporting regulatory submissions, health authority interactions, audits, and inspection readiness activities.
- Ability to operate as both a strategic function builder and a hands-on executor in an early-stage company environment.
- Strong cross-functional leadership skills, including the ability to influence senior stakeholders, drive alignment, and make clear recommendations when information is incomplete.
- Bachelor’s degree in life sciences, engineering, quality, or a related discipline, or an equivalent combination of education and relevant experience.
Then Preferred Qualifications
with bullets:
- Experience in cell therapy, gene therapy, in vivo genome editing, AAV, viral vectors, biologics, or other advanced therapy medicinal products.
- Experience as the first or early Quality hire
for prose. We must not repeat job title as heading. So no
Director/Senior Director, Quality Assurance
. We need to output only HTML fragment, no /, no markdown fences. Let's craft. Structure:About Azalea
...
How We Work
...
maybe include list of values? The text includes bullet-like list: Outcome Ownership, Comfort with Ambiguity, High Standards, Low Ego, Collaboration and Candor. Could be- .
The Opportunity
...
Key Responsibilities
- ... ... etc.
- Outcome Ownership - We own results, close loops, and follow through without needing to be prompted. We take responsibility for moving work forward and making sure important decisions, deliverables, and handoffs do not fall through the cracks. ... etc. Then
- . Need to capture all bullet points from the posting. Let's extract responsibilities: - Build and lead Azalea’s Quality Assurance function, including the quality strategy, operating model, roadmap, and resourcing plan appropriate for an early-stage biotechnology company advancing toward first-in-human studies. - Establish, implement, and continuously improve a phase-appropriate Quality Management System, including SOPs, document control, training, deviation and CAPA management, change control, risk management, vendor qualification, batch record review, product disposition, audits, complaints, and quality metrics. - Serve as the QA business partner to CMC, Process Development, Analytical Development, External Manufacturing, Regulatory Affairs, Clinical, and Program Team leaders to ensure quality considerations are embedded into program planning and execution. - Lead QA oversight of external consultants, CDMOs, testing laboratories, and other GxP vendors, including quality agreements, vendor qualification, audit planning, issue escalation, and ongoing performance management. - Establish and execute batch release and disposition processes for development, engineering, GMP, and future clinical materials, including review of batch records, deviations, investigations, analytical data packages, certificates of analysis, and supporting documentation. - Provide QA leadership for EDV and AAV manufacturing and analytics, including phase-appropriate controls for process development, analytical method development, pilot runs, engineering runs, and GMP manufacturing readiness. - Define and maintain quality requirements for labeling, packaging, and clinical supply documentation, including awareness of requirements that may apply inside and outside the United States. - Support regulatory strategy and submissions by contributing quality content, reviewing CMC documentation, preparing for health authority interactions, and ensuring commitments are tracked and closed. - Prepare the organization and work with external partners for audits and inspections by establishing inspection readiness practices, maintaining traceable documentation, and leading response planning for quality observations. - Develop practical quality risk management approaches that help Azalea make sound decisions in an early-stage environment while protecting patient safety, product quality, and data integrity. - Translate quality strategy into clear priorities, accountabilities, and decision points; close loops on issues that cross internal functions and external partners. - As the function grows, recruit, develop, and lead QA team members and consultants, setting expectations for high standards, direct communication, and accountable follow-through. We need to keep each as
- .
Then
Minimum Qualifications
- with each bullet.
Minimum qualifications list:
- 10 + years of progressive Quality Assurance leadership experience in biotechnology, biologics, cell therapy, gene therapy, or another complex modality with manufacturing and external partner oversight.
- Demonstrated experience partnering with CDMOs and external testing laboratories in a GMP environment.
- Proven track record establishing and scaling quality systems, SOPs, quality agreements, vendor oversight practices, and batch release processes in a biotechnology setting.
- Hands-on experience with product batch record review, deviation assessment, CAPA, change control, product disposition, and release documentation.
- Strong working knowledge of applicable GxP expectations and relevant U.S. and international Quality requirements for investigational products, clinical supply, labeling, documentation, and external manufacturing oversight.
- Experience supporting regulatory submissions, health authority interactions, audits, and inspection readiness activities.
- Ability to operate as both a strategic function builder and a hands-on executor in an early-stage company environment.
- Strong cross-functional leadership skills, including the ability to influence senior stakeholders, drive alignment, and make clear recommendations when information is incomplete.
- Bachelor’s degree in life sciences, engineering, quality, or a related discipline, or an equivalent combination of education and relevant experience.
Then
Preferred Qualifications
- with bullets:
- Experience in cell therapy, gene therapy, in vivo genome editing, AAV, viral vectors, biologics, or other advanced therapy medicinal products.
- Experience as the first or early Quality hire
Qualifications
We could split into Minimum and Preferred as subheadings? But instruction says usefor section headings; we could have
Minimum Qualifications
andPreferred Qualifications
as separate sections. That's okay. But we need to avoid too many thin sections; but it's fine. Alternatively combine into one Qualifications section with two lists. But we have distinct content; we can do two subheadings? Not allowed? Only said use
for section headings; didn't forbid other headings but better to stick to
. Could do
Minimum Qualifications
andPreferred Qualifications
.What Success Looks Like (first 3–6 months)
...
maybe list.Working Conditions / Physical Requirements
...
Compensation and Benefits
...
maybe list benefits. We need to preserve all substantive information; do not invent or summarize away detail. So we need to include details like: Azalea Therapeutics is enabling precision genome engineering directly inside the body, with an initial focus on creating cancer immunotherapies in vivo .Azalea is pioneering a new way to turn a person’s own T cells into a powerful cancer therapy — directly inside the body. Instead of removing cells and manipulating them in a lab, we use precision genome editing tools to engineer T cells where they already live. At the center of our approach are Enveloped Delivery Vehicles, or EDVs. As highly selective couriers, EDVs are designed to specifically locate T cells within the patient and deliver our genome engineering cargo. Once inside the cell, the anti-cancer agent is inserted into a precise site in the genome, ensuring safe and potent modifications to fortify the T cells against cancers. We need to keep that exactly. Also "Why This Matters" section: We aim to make cell therapy faster and more accessible by avoiding complex manufacturing outside the body. Our platform is designed for precision, so the right cells are safely programmed to effectively fight cancer. This technology has the potential to treat a wide range of cancers with a streamlined, scalable process. Our goal is simple: develop next-generation delivery technologies to bring genetic engineering and cell therapies to more patients. We should include that as part of About Azalea maybe separate? Could be its own section "Why This Matters". But instruction says include a section only when posting has real specific content. It does. Could addWhy This Matters
. However they gave examples of headings but not limited. We can add. But we need to avoid too many sections; but it's okay. We also have "How We Work Role" paragraph: "Azalea is building ambitious science in a fast-moving environment..." That's part of How We Work. We have "The Opportunity" paragraph. We have "Key Responsibilities" list. We have "Qualifications" with Minimum and Preferred. We have "What Success Looks Like (first 3–6 months)" paragraph. We have "Working Conditions / Physical Requirements": Onsite 2-3 days per week in our Berkeley office Travel up to 25% We have "Compensation And Benefits": salary range $185,000 - $260,000 per year. Offer amounts determined by factors... Salary will be commensurate with experience... This role is eligible for annual performance bonuses, equity grants, and a comprehensive benefits package that includes medical, dental, vision, retirement plan with company match, and paid time off. We need to keep that. We need to remove boilerplate: EEO, Reasonable Accommodation, Applicant Privacy, Job Description Disclaimer, Notice to Recruiters/Staffing Agencies, Information on Fraudulent Job Offers. Also remove duplicated lines. Now craft HTML. We'll need to escape any special characters? Not needed. Let's write. We'll start withAbout Azalea
then... include the description and maybe also Why This Matters as separate
Why This Matters
...
. ThenHow We Work
Azalea is building ambitious science in a fast-moving environment. The people who thrive here are accountable, adaptable, rigorous, humble, and direct. Across roles and functions, we look for team members who demonstrate the following:
thenThe Opportunity
The Director/Senior Director, Quality Assurance will be Azalea’s first dedicated Quality Assurance hire and will build the QA function required to support external manufacturing, GMP readiness, regulatory interactions, and future clinical supply. This is a hands-on leadership role for a Quality Assurance leader who can establish phase-appropriate and right-sized systems in an early-stage company while maintaining rigorous standards for patient safety, data integrity, and regulatory compliance. The role will partner closely with CMC, Process Development, Analytical Development, Regulatory Affairs, Clinical, and CDMO partners and consultants to advance AZA-2509 and pipeline programs toward first-in-human clinical development.
ThenKey Responsibilities
- with each responsibility as