Director, Quality Operations – Cell and Gene Therapy
for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title. Must not include Job ID etc. Must preserve all substantive info, remove boilerplate, navigation, legal, EEO, etc. Must not create sections with filler like "commensurate with experience". Must only include sections where posting has real content.
Let's parse the posting.
Overview: description of company, mission. That could be "About the role"? Actually "Overview" could be about the role/company. The instruction: use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can map content to these headings.
We have sections:
- Overview (company description) maybe "About the role" or "About the company". We'll use "About the role" heading.
- The Opportunity: mentions fully remote, reports to CTO, must reside in US, occasional travel. That's maybe "Responsibilities"? Actually that's more about role details. Could be "Responsibilities" but we have a separate "What You'll Do" section which lists responsibilities. So "The Opportunity" could be part of "About the role" or maybe "Schedule"? Not exactly. We'll incorporate into "About the role" or maybe "Responsibilities"? But we have a dedicated "What You'll Do" which enumerates responsibilities. So "The Opportunity" could be considered part of "About the role" (remote, reporting, location). We'll include that under About the role.
- What You’ll Do: list of duties (Quality Leadership and Strategy, Quality Operations and External Oversight, Compliance, Quality Systems, GCP Quality Oversight, Cross-Functional Partnership). That's responsibilities. So we will create a Responsibilities
with - items for each bullet.
- Qualifications: there is a "Qualifications" heading with bullet list of required qualifications. Also there is "Preferred Qualifications". We'll combine maybe under Requirements? Actually we have separate headings: Requirements, Qualifications, Skills. The posting uses "Qualifications" for required and "Preferred Qualifications". We could map required qualifications to "Requirements" or "Qualifications". The instruction says use headings e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we need to decide which to use. Likely "Requirements" for required qualifications, "Qualifications" for preferred? Or "Skills" for skills. Let's think: The posting includes "Qualifications" (required) and "Preferred Qualifications". Also includes skills like communication, leadership, etc. Those could go under Skills. We'll allocate:
- Requirements: Bachelor’s degree required; advanced degree preferred. 10+ years relevant quality experience; cell and gene therapy experience required; strong cell and gene therapy experience required in GMP quality operations and external partner oversight; working knowledge of GCP quality requirements; direct GCP quality experience preferred; demonstrated experience with quality systems management, supplier quality, audits, deviations, investigations, CAPAs, change control, inspection readiness; experience establishing and negotiating quality agreements; strong knowledge of FDA, EMA, ICH, etc.; proven ability to operate effectively in fast-paced development-stage company; excellent communication, leadership, cross-functional influencing skills; strong problem-solving skills and ability to apply risk-based, phase-appropriate quality decision-making.
That's a mix of requirements and skills. But we can separate: Requirements: education, years experience, cell/gene therapy required, GMP experience, GCP knowledge, experience with quality systems, supplier quality, audits, deviations, CAPAs, change control, inspection readiness, experience negotiating quality agreements, knowledge of regulations. Skills: communication, leadership, cross-functional influencing, problem-solving, risk-based decision making.
Preferred Qualifications: prior experience in autologous/allogeneic cell therapy, gene-edited products, other ATMP; experience supporting early clinical development through later-stage readiness; experience implementing or scaling quality systems in startup/emerging biotech; experience managing external consultants supporting quality, compliance, or clinical quality functions.
We could put Preferred Qualifications under "Qualifications" heading (maybe as a subsection). But we need to avoid filler. We'll include a
Qualifications
with both required and preferred? Might be confusing. Better to follow the given headings: Requirements, Qualifications, Skills. So:
- Requirements
: education, years experience, cell/gene therapy required, GMP experience, GCP knowledge, experience with quality systems, supplier quality, audits, deviations, CAPAs, change control, inspection readiness, experience negotiating quality agreements, knowledge of FDA/EMA/ICH, ability to operate in fast-paced dev-stage.
- Skills
: excellent communication, leadership, cross-functional influencing, strong problem-solving, ability to apply risk-based, phase-appropriate quality decision-making.
- Qualifications
: Preferred Qualifications (autologous/allogeneic cell therapy, gene-edited, ATMP; early clinical development experience; implementing/scaling quality systems in startup; managing external consultants). Could also include "advanced degree preferred" but that's already in Requirements? We'll keep advanced degree preferred under Requirements maybe.
Now Benefits: The posting includes "Why Join CoRegen" paragraph about culture, then "We offer a comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits (for employee and family), a 401(k) plan, paid sick days, generous paid holidays, and unlimited PTO." That's benefits. So we will create Benefits
with - items.
Pay: The posting includes salary range: "CoRegen is required by state specific laws to include the salary range for this role when hiring a resident in applicable locations. This role’s base salary is expected to be $215,000 - $250,000 USD annually. Actual pay depends on many factors including geographic location, your experience, training, and unique skills. The range may be updated as company or market needs evolve." That's specific pay info. So we will create
Pay
with a containing that info.
Schedule: The posting mentions "This position is fully remote ... occasional travel within the United States will be required." That's about schedule/location/travel. Could be considered Schedule. There's no explicit schedule like full-time, but we can infer full-time. However we should not create a Schedule section unless posting actually states them. It does mention occasional travel required. That's schedule-related. We could create a
Schedule
with a stating fully remote, occasional travel within US required. That seems appropriate.
Now About the role: We'll include overview description, opportunity details (remote, reports to CTO, must reside in US, occasional travel). Also maybe mention mission-driven etc. We'll combine.
We must not repeat job title. No Job ID etc.
We must remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning, duplicated lines, application instructions. The posting doesn't have obvious EEO but there is a line about CoRegen required by state specific laws to include salary range - that's not boilerplate, it's about pay disclosure, we keep it in Pay.
We must preserve all substantive information. Let's extract.
Overview paragraph: "CoRegen is a mission-driven biotechnology company built by a world-class leadership team with experience at some of the most prominent and respected companies in life sciences. We are united by a shared commitment to scientific advancement, operational excellence, and meaningful impact on patients’ lives."
Opportunity: "As we continue to grow, we are seeking a highly motivated Director of Quality candidate with required, hands-on experience in the cell and gene therapy industry to lead quality operations and compliance across the company’s GxP activities, with a primary focus on GMP quality systems, external partner oversight, and cGMP readiness in support of our cell therapy pipeline. Operating within a virtual model, this individual will provide strategic and hands-on leadership for quality oversight of CDMOs, testing laboratories, and other GxP vendors, while also ensuring appropriate internal oversight of GCP quality activities through collaboration with external consultants. The ideal candidate will bring deep quality operations experience, strong judgment, and the ability to build scalable, phase-appropriate quality infrastructure in a fast-paced development environment."
The Opportunity section: "This position is fully remote and reports to the Chief Technical Officer. Candidates must reside in the United States to support our Quality Operations team, occasional travel within the United States will be required."
What You’ll Do: list of responsibilities.
Qualifications: required list.
Preferred Qualifications: list.
Why Join CoRegen: culture paragraph.
Benefits: "We offer a comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits (for employee and family), a 401(k) plan, paid sick days, generous paid holidays, and unlimited PTO."
Pay: salary range paragraph.
Now we need to output HTML fragment only.
We'll structure:
About the role
... (overview + opportunity)
Responsibilities
- ...
...
Requirements
- ...
...
Skills
- ...
...
Qualifications
- ...
...
Benefits
- ...
...
Pay
...
Schedule
...
We need to ensure we don't create empty sections. All have content.
Now let's craft the content.
About the role paragraph: combine overview and opportunity.
Paragraph: "CoRegen is a mission-driven biotechnology company built by a world-class leadership team with experience at some of the most prominent and respected companies in life sciences. We are united by a shared commitment to scientific advancement, operational excellence, and meaningful impact on patients’ lives. As we continue to grow, we are seeking a highly motivated Director of Quality candidate with required, hands-on experience in the cell and gene therapy industry to lead quality operations and compliance across the company’s GxP activities, with a primary focus on GMP quality systems, external partner oversight, and cGMP readiness in support of our cell therapy pipeline. Operating within a virtual model, this individual will provide strategic and hands-on leadership for quality oversight of CDMOs, testing laboratories, and other GxP vendors, while also ensuring appropriate internal oversight of GCP quality activities through collaboration with external consultants. The ideal candidate will bring deep quality operations experience, strong judgment, and the ability to build scalable, phase-appropriate quality infrastructure in a fast-paced development environment. This position is fully remote and reports to the Chief Technical Officer. Candidates must reside in the United States to support our Quality Operations team, occasional travel within the United States will be required."
That's fine.
Responsibilities: list each bullet from "What You’ll Do". Let's extract:
- Quality Leadership and Strategy
* Lead the development, implementation, and continuous improvement of CoRegen’s phase-appropriate Quality Management System across GxP activities.
* Serve as the company’s primary quality leader, providing strategic guidance to senior leadership on quality risk, compliance, inspection readiness, and operational quality priorities.
* Build a scalable quality framework suitable for a virtual biotechnology company advancing cell therapy products from development into clinical manufacturing and beyond.
* Establish quality governance processes, metrics, and management review mechanisms to support informed decision-making and continuous improvement.
- Quality Operations and External Oversight
* Provide end-to-end quality oversight of external manufacturers, testing laboratories, and other GxP service providers supporting CoRegen programs.
* Serve as the primary quality point of contact for assigned CDMOs and external partners, building strong and effective working relationships
Responsibilities
with- items for each bullet.
- Qualifications: there is a "Qualifications" heading with bullet list of required qualifications. Also there is "Preferred Qualifications". We'll combine maybe under Requirements? Actually we have separate headings: Requirements, Qualifications, Skills. The posting uses "Qualifications" for required and "Preferred Qualifications". We could map required qualifications to "Requirements" or "Qualifications". The instruction says use headings e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we need to decide which to use. Likely "Requirements" for required qualifications, "Qualifications" for preferred? Or "Skills" for skills. Let's think: The posting includes "Qualifications" (required) and "Preferred Qualifications". Also includes skills like communication, leadership, etc. Those could go under Skills. We'll allocate:
- Requirements: Bachelor’s degree required; advanced degree preferred. 10+ years relevant quality experience; cell and gene therapy experience required; strong cell and gene therapy experience required in GMP quality operations and external partner oversight; working knowledge of GCP quality requirements; direct GCP quality experience preferred; demonstrated experience with quality systems management, supplier quality, audits, deviations, investigations, CAPAs, change control, inspection readiness; experience establishing and negotiating quality agreements; strong knowledge of FDA, EMA, ICH, etc.; proven ability to operate effectively in fast-paced development-stage company; excellent communication, leadership, cross-functional influencing skills; strong problem-solving skills and ability to apply risk-based, phase-appropriate quality decision-making.
That's a mix of requirements and skills. But we can separate: Requirements: education, years experience, cell/gene therapy required, GMP experience, GCP knowledge, experience with quality systems, supplier quality, audits, deviations, CAPAs, change control, inspection readiness, experience negotiating quality agreements, knowledge of regulations. Skills: communication, leadership, cross-functional influencing, problem-solving, risk-based decision making.
Preferred Qualifications: prior experience in autologous/allogeneic cell therapy, gene-edited products, other ATMP; experience supporting early clinical development through later-stage readiness; experience implementing or scaling quality systems in startup/emerging biotech; experience managing external consultants supporting quality, compliance, or clinical quality functions.
We could put Preferred Qualifications under "Qualifications" heading (maybe as a subsection). But we need to avoid filler. We'll include a
Qualifications
with both required and preferred? Might be confusing. Better to follow the given headings: Requirements, Qualifications, Skills. So: -Requirements
: education, years experience, cell/gene therapy required, GMP experience, GCP knowledge, experience with quality systems, supplier quality, audits, deviations, CAPAs, change control, inspection readiness, experience negotiating quality agreements, knowledge of FDA/EMA/ICH, ability to operate in fast-paced dev-stage. -Skills
: excellent communication, leadership, cross-functional influencing, strong problem-solving, ability to apply risk-based, phase-appropriate quality decision-making. -Qualifications
: Preferred Qualifications (autologous/allogeneic cell therapy, gene-edited, ATMP; early clinical development experience; implementing/scaling quality systems in startup; managing external consultants). Could also include "advanced degree preferred" but that's already in Requirements? We'll keep advanced degree preferred under Requirements maybe. Now Benefits: The posting includes "Why Join CoRegen" paragraph about culture, then "We offer a comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits (for employee and family), a 401(k) plan, paid sick days, generous paid holidays, and unlimited PTO." That's benefits. So we will createBenefits
with- items.
Pay: The posting includes salary range: "CoRegen is required by state specific laws to include the salary range for this role when hiring a resident in applicable locations. This role’s base salary is expected to be $215,000 - $250,000 USD annually. Actual pay depends on many factors including geographic location, your experience, training, and unique skills. The range may be updated as company or market needs evolve." That's specific pay info. So we will create
Pay
with acontaining that info. Schedule: The posting mentions "This position is fully remote ... occasional travel within the United States will be required." That's about schedule/location/travel. Could be considered Schedule. There's no explicit schedule like full-time, but we can infer full-time. However we should not create a Schedule section unless posting actually states them. It does mention occasional travel required. That's schedule-related. We could create a
Schedule
with astating fully remote, occasional travel within US required. That seems appropriate. Now About the role: We'll include overview description, opportunity details (remote, reports to CTO, must reside in US, occasional travel). Also maybe mention mission-driven etc. We'll combine. We must not repeat job title. No Job ID etc. We must remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning, duplicated lines, application instructions. The posting doesn't have obvious EEO but there is a line about CoRegen required by state specific laws to include salary range - that's not boilerplate, it's about pay disclosure, we keep it in Pay. We must preserve all substantive information. Let's extract. Overview paragraph: "CoRegen is a mission-driven biotechnology company built by a world-class leadership team with experience at some of the most prominent and respected companies in life sciences. We are united by a shared commitment to scientific advancement, operational excellence, and meaningful impact on patients’ lives." Opportunity: "As we continue to grow, we are seeking a highly motivated Director of Quality candidate with required, hands-on experience in the cell and gene therapy industry to lead quality operations and compliance across the company’s GxP activities, with a primary focus on GMP quality systems, external partner oversight, and cGMP readiness in support of our cell therapy pipeline. Operating within a virtual model, this individual will provide strategic and hands-on leadership for quality oversight of CDMOs, testing laboratories, and other GxP vendors, while also ensuring appropriate internal oversight of GCP quality activities through collaboration with external consultants. The ideal candidate will bring deep quality operations experience, strong judgment, and the ability to build scalable, phase-appropriate quality infrastructure in a fast-paced development environment." The Opportunity section: "This position is fully remote and reports to the Chief Technical Officer. Candidates must reside in the United States to support our Quality Operations team, occasional travel within the United States will be required." What You’ll Do: list of responsibilities. Qualifications: required list. Preferred Qualifications: list. Why Join CoRegen: culture paragraph. Benefits: "We offer a comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits (for employee and family), a 401(k) plan, paid sick days, generous paid holidays, and unlimited PTO." Pay: salary range paragraph. Now we need to output HTML fragment only. We'll structure:
About the role
... (overview + opportunity)
Responsibilities
- ... ...
Requirements
- ... ...
Skills
- ... ...
Qualifications
- ... ...
Benefits
- ... ...
Pay
...
Schedule
...
We need to ensure we don't create empty sections. All have content. Now let's craft the content. About the role paragraph: combine overview and opportunity. Paragraph: "CoRegen is a mission-driven biotechnology company built by a world-class leadership team with experience at some of the most prominent and respected companies in life sciences. We are united by a shared commitment to scientific advancement, operational excellence, and meaningful impact on patients’ lives. As we continue to grow, we are seeking a highly motivated Director of Quality candidate with required, hands-on experience in the cell and gene therapy industry to lead quality operations and compliance across the company’s GxP activities, with a primary focus on GMP quality systems, external partner oversight, and cGMP readiness in support of our cell therapy pipeline. Operating within a virtual model, this individual will provide strategic and hands-on leadership for quality oversight of CDMOs, testing laboratories, and other GxP vendors, while also ensuring appropriate internal oversight of GCP quality activities through collaboration with external consultants. The ideal candidate will bring deep quality operations experience, strong judgment, and the ability to build scalable, phase-appropriate quality infrastructure in a fast-paced development environment. This position is fully remote and reports to the Chief Technical Officer. Candidates must reside in the United States to support our Quality Operations team, occasional travel within the United States will be required." That's fine. Responsibilities: list each bullet from "What You’ll Do". Let's extract: - Quality Leadership and Strategy * Lead the development, implementation, and continuous improvement of CoRegen’s phase-appropriate Quality Management System across GxP activities. * Serve as the company’s primary quality leader, providing strategic guidance to senior leadership on quality risk, compliance, inspection readiness, and operational quality priorities. * Build a scalable quality framework suitable for a virtual biotechnology company advancing cell therapy products from development into clinical manufacturing and beyond. * Establish quality governance processes, metrics, and management review mechanisms to support informed decision-making and continuous improvement. - Quality Operations and External Oversight * Provide end-to-end quality oversight of external manufacturers, testing laboratories, and other GxP service providers supporting CoRegen programs. * Serve as the primary quality point of contact for assigned CDMOs and external partners, building strong and effective working relationships
- items.
Pay: The posting includes salary range: "CoRegen is required by state specific laws to include the salary range for this role when hiring a resident in applicable locations. This role’s base salary is expected to be $215,000 - $250,000 USD annually. Actual pay depends on many factors including geographic location, your experience, training, and unique skills. The range may be updated as company or market needs evolve." That's specific pay info. So we will create