Senior Manager GCP Quality
BioSpace · Dublin, OH · 3 wk ago
Quality AssuranceFull-time
We need to output HTML fragment with sections: About the role? The posting includes description. We need to use for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections when posting has real specific content. We must preserve all substantive info, not invent. Remove boilerplate like EEO, legal, etc. Also remove navigation, cookie, application instructions. So we need to extract content.
Let's parse the posting:
"Build Our Future Together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, GCP Quality Management - Global Development to join our Global Development Quality team, supporting our global clinical development organisation in a hybrid work model. In this role, you will lead risk-based quality management across clinical trials while collaborating with study teams, clinical functions, contract research organisations, and quality colleagues. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. When & Where Multiple locations are being considered for this role (Hybrid) Discover Your Role Lead risk-based quality management across assigned clinical trials Drive protocol-stage Quality Risk Assessment and Control Tracker activities under ICH E6 R3 Manage quality issues, audit responses, corrective actions, preventive actions, and trend analysis Partner with study leads, monitoring teams, and contract research organisations on site risks Escalate significant quality events and trends to Executive Quality Leadership Support inspection readiness, responses, and follow-up actions across relevant functions Manage onboarding, development goals, coaching, performance discussions, and team administration You champion quality, integrity, continuous learning, and trusted partnerships This Role Requires Bachelors degree and eight years relevant healthcare or pharmaceutical industry experience Quality, compliance, clinical development, Good Clinical Practice, or Good Pharmacovigilance Practice experience Advanced risk-based quality management, risk assessment, and compliance knowledge Experience managing complex issues, regulatory inspections, and inspection readiness Subject matter expert, process owner, training, presentation, and staff management experience Process improvement, project management, prioritisation, and time management skills Advanced Microsoft Outlook, Word, Excel, and PowerPoint skills Strong communication, collaboration Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter. Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location. As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications. For jobs in Canada: this posting is for an existing position. Salary Range (annually)"
We need to remove EEO, legal, etc. Also remove application instructions like "Apply now", "If you have any questions, please speak with your recruiter", etc. Also remove background checks etc. Also remove "When & Where Multiple locations are being considered for this role (Hybrid)" maybe part of location but not needed as heading? Could be part of About the role.
We need sections: About the role (intro), Responsibilities (list of duties), Requirements (maybe education/experience), Qualifications (maybe similar), Skills (list of skills), Benefits (list of benefits), Pay (if salary range mentioned), Schedule (if schedule mentioned). The posting mentions hybrid work model, but not explicit schedule. It says "supporting our global clinical development organisation in a hybrid work model." That could be schedule info. But we should only include Schedule section if posting actually states schedule specifics (like full-time, part-time, shift). Hybrid work model is more about location. Might not qualify as schedule. The instruction: "never create Pay/Schedule/Benefits sections unless the posting actually states them." Benefits: posting mentions total rewards package with list. That's benefits. So include Benefits.
Pay: posting says "Salary Range (annually)" at end but no actual numbers. It says "Salary Range (annually)" but no value. That's placeholder? It's just heading with no value. According to rule: never emit a heading followed by filler/placeholder text (e.g., "commensurate with experience", "not specified", "N/A", "varies", "TBD"). "Salary Range (annually)" is placeholder without actual range. So we should NOT include Pay section.
Schedule: hybrid work model is not a schedule; it's location. Might be considered schedule? Probably not. Safer to omit Schedule.
Now we need to extract substantive content.
About the role: first paragraph(s) describing role and company. Could be: "Build Our Future Together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, GCP Quality Management - Global Development to join our Global Development Quality team, supporting our global clinical development organisation in a hybrid work model. In this role, you will lead risk-based quality management across clinical trials while collaborating with study teams, clinical functions, contract research organisations, and quality colleagues. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide."
That's about the role.
Responsibilities: list of duties after "Discover Your Role". The bullet-like sentences: "Lead risk-based quality management across assigned clinical trials", "Drive protocol-stage Quality Risk Assessment and Control Tracker activities under ICH E6 R3", "Manage quality issues, audit responses, corrective actions, preventive actions, and trend analysis", "Partner with study leads, monitoring teams, and contract research organisations on site risks", "Escalate significant quality events and trends to Executive Quality Leadership", "Support inspection readiness, responses, and follow-up actions across relevant functions", "Manage onboarding, development goals, coaching, performance discussions, and team administration", "You champion quality, integrity, continuous learning, and trusted partnerships". We'll put these as
for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections when posting has real specific content. We must preserve all substantive info, not invent. Remove boilerplate like EEO, legal, etc. Also remove navigation, cookie, application instructions. So we need to extract content.
Let's parse the posting:
"Build Our Future Together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, GCP Quality Management - Global Development to join our Global Development Quality team, supporting our global clinical development organisation in a hybrid work model. In this role, you will lead risk-based quality management across clinical trials while collaborating with study teams, clinical functions, contract research organisations, and quality colleagues. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. When & Where Multiple locations are being considered for this role (Hybrid) Discover Your Role Lead risk-based quality management across assigned clinical trials Drive protocol-stage Quality Risk Assessment and Control Tracker activities under ICH E6 R3 Manage quality issues, audit responses, corrective actions, preventive actions, and trend analysis Partner with study leads, monitoring teams, and contract research organisations on site risks Escalate significant quality events and trends to Executive Quality Leadership Support inspection readiness, responses, and follow-up actions across relevant functions Manage onboarding, development goals, coaching, performance discussions, and team administration You champion quality, integrity, continuous learning, and trusted partnerships This Role Requires Bachelors degree and eight years relevant healthcare or pharmaceutical industry experience Quality, compliance, clinical development, Good Clinical Practice, or Good Pharmacovigilance Practice experience Advanced risk-based quality management, risk assessment, and compliance knowledge Experience managing complex issues, regulatory inspections, and inspection readiness Subject matter expert, process owner, training, presentation, and staff management experience Process improvement, project management, prioritisation, and time management skills Advanced Microsoft Outlook, Word, Excel, and PowerPoint skills Strong communication, collaboration Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter. Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location. As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications. For jobs in Canada: this posting is for an existing position. Salary Range (annually)"
We need to remove EEO, legal, etc. Also remove application instructions like "Apply now", "If you have any questions, please speak with your recruiter", etc. Also remove background checks etc. Also remove "When & Where Multiple locations are being considered for this role (Hybrid)" maybe part of location but not needed as heading? Could be part of About the role.
We need sections: About the role (intro), Responsibilities (list of duties), Requirements (maybe education/experience), Qualifications (maybe similar), Skills (list of skills), Benefits (list of benefits), Pay (if salary range mentioned), Schedule (if schedule mentioned). The posting mentions hybrid work model, but not explicit schedule. It says "supporting our global clinical development organisation in a hybrid work model." That could be schedule info. But we should only include Schedule section if posting actually states schedule specifics (like full-time, part-time, shift). Hybrid work model is more about location. Might not qualify as schedule. The instruction: "never create Pay/Schedule/Benefits sections unless the posting actually states them." Benefits: posting mentions total rewards package with list. That's benefits. So include Benefits.
Pay: posting says "Salary Range (annually)" at end but no actual numbers. It says "Salary Range (annually)" but no value. That's placeholder? It's just heading with no value. According to rule: never emit a heading followed by filler/placeholder text (e.g., "commensurate with experience", "not specified", "N/A", "varies", "TBD"). "Salary Range (annually)" is placeholder without actual range. So we should NOT include Pay section.
Schedule: hybrid work model is not a schedule; it's location. Might be considered schedule? Probably not. Safer to omit Schedule.
Now we need to extract substantive content.
About the role: first paragraph(s) describing role and company. Could be: "Build Our Future Together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, GCP Quality Management - Global Development to join our Global Development Quality team, supporting our global clinical development organisation in a hybrid work model. In this role, you will lead risk-based quality management across clinical trials while collaborating with study teams, clinical functions, contract research organisations, and quality colleagues. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide."
That's about the role.
Responsibilities: list of duties after "Discover Your Role". The bullet-like sentences: "Lead risk-based quality management across assigned clinical trials", "Drive protocol-stage Quality Risk Assessment and Control Tracker activities under ICH E6 R3", "Manage quality issues, audit responses, corrective actions, preventive actions, and trend analysis", "Partner with study leads, monitoring teams, and contract research organisations on site risks", "Escalate significant quality events and trends to Executive Quality Leadership", "Support inspection readiness, responses, and follow-up actions across relevant functions", "Manage onboarding, development goals, coaching, performance discussions, and team administration", "You champion quality, integrity, continuous learning, and trusted partnerships". We'll put these as - .
Requirements: maybe education/experience: "Bachelors degree and eight years relevant healthcare or pharmaceutical industry experience". That's a requirement.
Qualifications: maybe "Quality, compliance, clinical development, Good Clinical Practice, or Good Pharmacovigilance Practice experience". Could be qualifications.
Skills: list: "Advanced risk-based quality management, risk assessment, and compliance knowledge", "Experience managing complex issues, regulatory inspections, and inspection readiness", "Subject matter expert, process owner, training, presentation, and staff management experience", "Process improvement, project management, prioritisation, and time management skills", "Advanced Microsoft Outlook, Word, Excel, and PowerPoint skills", "Strong communication, collaboration". Could be skills.
Benefits: list: "annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits."
We need to ensure we don't repeat content. Also we need to avoid duplication.
We must not include boilerplate like EEO, legal, accommodation, background checks, etc.
We also need to remove "Does this sound like you? Apply now to take your first step towards living the Regeneron Way!" etc.
Also remove "We are committed to building a workplace with an inclusive culture." That's EEO-ish but maybe not boilerplate? It's about inclusive culture; could be considered part of About the role? Might be okay to keep but it's generic. Safer to omit as it's not specific to role. The instruction: remove EEO/equal-opportunity/scam-warning boilerplate. That line is about inclusive culture, maybe not EEO but could be considered boilerplate. Safer to omit.
Also remove "Where required, we will provide reasonable accommodation..." etc.
Also remove "For additional information about Regeneron benefits in the U.S., please visit ..." that's application instruction? It's a link but maybe part of benefits? It's a reference; could be kept but it's more like instruction. Might be okay to keep as part of benefits? But it's a link; maybe we can keep but it's not a benefit itself. Safer to omit.
Also remove "If you have any questions, please speak with your recruiter." etc.
Also remove "Please be advised that at Regeneron, we believe we do our best work when we are together..." etc.
Also remove background checks etc.
Also remove "For jobs in Canada: this posting is for an existing position." That's minor metadata; could be dropped.
Now produce HTML fragment.
We need headings:
About the role
, then ...
. Then Responsibilities
then - ... etc. Then
Requirements
then Bachelors degree and eight years relevant healthcare or pharmaceutical industry experience.
. Then Qualifications
then Quality, compliance, clinical development, Good Clinical Practice, or Good Pharmacovigilance Practice experience.
. Then Skills
then - ... each skill as li? Could combine multiple in one li but better separate. We'll list each.
Then
Benefits
then - ... each benefit as li.
We must not include Pay or Schedule.
Check for any leftover boilerplate: ensure no mention of "Apply now", "equal opportunity", etc.
Let's craft.
About the role paragraph: combine first sentences.
"Build Our Future Together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, GCP Quality Management - Global Development to join our Global Development Quality team, supporting our global clinical development organisation in a hybrid work model. In this role, you will lead risk-based quality management across clinical trials while collaborating with study teams, clinical functions, contract research organisations, and quality colleagues. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide."
That's fine.
Responsibilities list:
- Lead risk-based quality management across assigned clinical trials
- Drive protocol-stage Quality Risk Assessment and Control Tracker activities under ICH E6 R3
- Manage quality issues, audit responses, corrective actions, preventive actions, and trend analysis
- Partner with study leads, monitoring teams, and contract research organisations on site risks
- Es
About the role
, then...
. ThenResponsibilities
then- ... etc. Then
Requirements
thenBachelors degree and eight years relevant healthcare or pharmaceutical industry experience.
. ThenQualifications
thenQuality, compliance, clinical development, Good Clinical Practice, or Good Pharmacovigilance Practice experience.
. ThenSkills
then- ... each skill as li? Could combine multiple in one li but better separate. We'll list each.
Then
Benefits
then- ... each benefit as li. We must not include Pay or Schedule. Check for any leftover boilerplate: ensure no mention of "Apply now", "equal opportunity", etc. Let's craft. About the role paragraph: combine first sentences. "Build Our Future Together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, GCP Quality Management - Global Development to join our Global Development Quality team, supporting our global clinical development organisation in a hybrid work model. In this role, you will lead risk-based quality management across clinical trials while collaborating with study teams, clinical functions, contract research organisations, and quality colleagues. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide." That's fine. Responsibilities list: - Lead risk-based quality management across assigned clinical trials - Drive protocol-stage Quality Risk Assessment and Control Tracker activities under ICH E6 R3 - Manage quality issues, audit responses, corrective actions, preventive actions, and trend analysis - Partner with study leads, monitoring teams, and contract research organisations on site risks - Es
- ... each skill as li? Could combine multiple in one li but better separate. We'll list each.
Then