Executive Director, Microbiology Quality Sterility Assurance
for section headings. Use - for any list of duties/requirements/benefits. Use
for prose.
We must not include filler like "commensurate with experience". Avoid.
We need to preserve all substantive info; not invent or summarize away detail. So we need to include details from responsibilities, qualifications, benefits, pay, travel, work models maybe under About the role? Could include in About the role: purpose-driven culture, position summary, travel %, work model.
We must not repeat job title. So no heading for job title.
We must not include Job ID/requisition numbers.
We must remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. So we should omit the EEO statement, candidate rights, supporting people with disabilities, how we work links maybe? Those are boilerplate? The instruction: remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate. The "Supporting People With Disabilities" and "Candidate Rights" are EEO-related; likely remove. "How We Work" maybe not EEO but could be considered generic; but it's about work models; could be considered substantive? It describes work models; maybe keep as part of About the role? But it's a link; we could keep description but not the link? The instruction: preserve ALL substantive information; do NOT invent or summarize away detail. The work model info is substantive; we could include in About the role.
But the "Supporting People With Disabilities" and "Candidate Rights" are EEO boilerplate; remove.
Also remove "We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway." That's application encouragement; maybe considered boilerplate? It's not EEO but could be considered generic encouraging; but it's substantive? It's a statement encouraging applicants; could be considered boilerplate but not EEO. Might keep? Safer to keep as part of About the role? It's not a list; could be a paragraph.
We need to avoid duplication.
Let's extract sections:
About the role: include purpose-driven culture statement, position summary, travel %, work model (site-essential etc), maybe the encouraging statement.
Responsibilities: list all key responsibilities bullet points. The posting has many subheadings: Strategic Leadership & Sterility Assurance Governance, CMO & External Partner Management, Microbiological Quality & Technical Oversight, Regulatory & Compliance, Business Planning & Capital Strategy, External Advocacy, People Leadership & Capability Development. We need to turn each bullet into list items. Could group under each subheading? But we only need
- for any list of duties/requirements/benefits. We could create a flat list of responsibilities, preserving details. Might be long but okay.
Requirements: maybe combine required qualifications and experience. Could list required: Bachelor's degree in Scientific Discipline preferably Microbiology Life Sciences Biological Sciences; Significant progressive experience in aseptic or bioburden control manufacturing environments (production, QA, validation) with demonstrated successful results in HA-regulated environment; 10+ years people management experience leading large globally distributed teams; Proven experience in aseptic/sterility assurance across pharma, biopharma, medical device; Experience leading or supporting regulatory inspections and PAIs including direct engagement with HA as senior technical SME; Demonstrated ability to lead through influence in complex global matrix organization; Executive presence with ability to communicate and influence at VP/SVP/C-Suite level internally and externally.
Qualifications: preferred: Advanced degree (MS, MPhil, PhD, MTD) in Microbiology Industrial Microbiology Clinical Microbiology Bacterial Toxicology; Experience working within or managing CMO partnerships in QA capacity; Experience in due diligence for CMO onboarding and new product launch; Experience with industry standard-setting activities through PDA, ISPE, PhRMA or equivalent.
Skills: Not explicitly listed; maybe we could omit Skills section if no specific skills list. The instruction: prefer a few substantive sections over many thin ones. So we could omit Skills.
Benefits: list benefits: comprehensive benefit plans – wellbeing support, retirement and financial protection benefits, insurance offerings (medical, dental, vision, life and disability); U.S.-based exempt employees eligible for Flexible Time Off (FTO) paid time off without set accrual limit, manager approval, plus 11 paid company holidays; Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours paid vacation annually for new hires (manager approval), 11 paid company holidays, 3 optional holidays; Depending on eligibility, employees may also have access to additional time-off benefits: paid sick leave, up to two paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs; Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day; U.S.-based job seekers can explore full benefit offerings at link (maybe we keep link? It's a reference; could keep as part of paragraph). We'll keep as prose.
Pay: compensation overview: $260,860 - $316,097 starting pay range for full-time employees; may also be eligible for additional discretionary incentive cash and stock opportunities; starting pay determined thoughtfully considering role nature, required skills, work location, schedule, knowledge/experience; final compensation guided by pay equity principles and applicable employment laws; compensation programs reviewed ongoing and may be adjusted.
Schedule: Not explicit; we have travel 30-50%; work models; but schedule not given. Could we treat travel as schedule? Probably not. Safer to omit Schedule.
Now produce HTML fragment:
About the role
... paragraphs ...
Responsibilities
- ... each responsibility ...
Requirements
- ... each required qualification ...
Qualifications
- ... each preferred qualification ...
Benefits
... benefits paragraph ...
Pay
... compensation paragraph ...
We must not include empty sections.
Now craft content precisely, preserving details.
Let's write About the role paragraph:
"At Bristol Myers Squibb, employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency. The purpose‑driven culture inspires the discovery, development, and delivery of innovative medicines to prevail over serious diseases, offering uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This role is the Executive Director, Microbiology Quality Sterility Assurance (MQSA), a pivotal global leadership position within BMS's Corporate Quality organization. It requires defining, owning, and governing the enterprise‑wide Contamination Control Strategy (CCS) as a living, risk‑based framework aligned with EU GMP Annex 1, FDA, and all applicable global regulatory standards, serving as the global Single Point of Contact for sterility assurance and microbiology quality matters. The position expects 30‑50% travel and follows a work model determined by its core responsibilities (site‑essential, site‑by‑design, field‑based, or remote‑by‑design)."
We could also include the encouraging statement: "We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway." Might add as another sentence.
Now Responsibilities: need to capture all bullet points from the posting.
Let's extract each bullet from the responsibilities section:
From "Strategic Leadership & Sterility Assurance Governance":
- Define, own, and drive BMS's Global Sterility & Microbiology Assurance Strategy, ensuring alignment across all manufacturing sites, CMOs, MS&T, GTS and PD partners
- Serve as the primary executive-level contact for contamination control and sterility assurance across Operations, Engineering, MS&T, and PD
- Embed control contamination and aseptic assurance strategy and aseptic-by-design principles into future processes and product development programs
- Lead remediation plans following regulatory observations, ensuring proactive installation of appropriate aseptic assurance standards (QMS and standard work) across the business
- Champion continuous improvement initiatives including KPI trending and capability development in aseptic and sterility assurance domains and process confirmations
- Own and periodically review BMS's Global CCS as a living document, ensuring it reflects current regulatory requirements
- Establish, own, and govern BMS's global sterility/aseptic assurance and CCS performance metrics framework, including KPI definitions, network-level escalation thresholds, trend analysis, and executive-level reporting cadence
From "CMO & External Partner Management":
- Support any implementation of BMS's Sterility Assurance Strategy
- Lead CMO support in establishing and executing annual Contamination Control Strategies (CCS) and Aseptic/Sterility Assurance Roadmaps
- Partner with CMOs for KPI analysis, trending, escalation, and gap assessments versus BMS standards (GQPs, QMS, FDA Guidance, etc.)
- Conduct due diligence activities during onboarding of new CMOs
- Drive alignment in ways of working and standard operating procedures between all CMO partners in aseptic/sterility assurance subjects
From "Microbiological Quality & Technical Oversight":
- Provide deep technical oversight of microbiological controls across pharmaceutical, biopharmaceutical, cell therapy, radiopharmaceutical and drug product manufacturing operations
- Lead the identification, qualification, and validation of terminal sterilization suppliers
- Provide expert technical guidance across product design, process controls, and organizational capabilities with a focus on microbiological controls
- Drive the adoption of advanced analytics, digital environmental monitoring tools, and data-driven risk assessment approaches to enhance contamination surveillance and EM trending across the network
- Lead or oversee complex cross-site microbiological investigations, CAPA development, and systemic remediation efforts, ensuring robust root cause analysis and sustainable corrective actions
From "Regulatory & Compliance":
- Maintain in-depth knowledge of global regulations, guidance documents, and industry best practices related to sterility assurance, including: EU GMP, FDA, WHO, PDA, ASTM, ISPE, PhRMA, and BMS internal standards
- Support review of regulatory filings related to sterility assurance and microbiology
- Lead or actively support sterility assurance-related regulatory inspections globally, including direct engagement with FDA, EMA, MHRA, and other Health Authorities
- Lead assessment and adoption of new or updated regulations (
for prose. We must not include filler like "commensurate with experience". Avoid. We need to preserve all substantive info; not invent or summarize away detail. So we need to include details from responsibilities, qualifications, benefits, pay, travel, work models maybe under About the role? Could include in About the role: purpose-driven culture, position summary, travel %, work model. We must not repeat job title. So no heading for job title. We must not include Job ID/requisition numbers. We must remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. So we should omit the EEO statement, candidate rights, supporting people with disabilities, how we work links maybe? Those are boilerplate? The instruction: remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate. The "Supporting People With Disabilities" and "Candidate Rights" are EEO-related; likely remove. "How We Work" maybe not EEO but could be considered generic; but it's about work models; could be considered substantive? It describes work models; maybe keep as part of About the role? But it's a link; we could keep description but not the link? The instruction: preserve ALL substantive information; do NOT invent or summarize away detail. The work model info is substantive; we could include in About the role. But the "Supporting People With Disabilities" and "Candidate Rights" are EEO boilerplate; remove. Also remove "We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway." That's application encouragement; maybe considered boilerplate? It's not EEO but could be considered generic encouraging; but it's substantive? It's a statement encouraging applicants; could be considered boilerplate but not EEO. Might keep? Safer to keep as part of About the role? It's not a list; could be a paragraph. We need to avoid duplication. Let's extract sections: About the role: include purpose-driven culture statement, position summary, travel %, work model (site-essential etc), maybe the encouraging statement. Responsibilities: list all key responsibilities bullet points. The posting has many subheadings: Strategic Leadership & Sterility Assurance Governance, CMO & External Partner Management, Microbiological Quality & Technical Oversight, Regulatory & Compliance, Business Planning & Capital Strategy, External Advocacy, People Leadership & Capability Development. We need to turn each bullet into list items. Could group under each subheading? But we only need
- for any list of duties/requirements/benefits. We could create a flat list of responsibilities, preserving details. Might be long but okay.
Requirements: maybe combine required qualifications and experience. Could list required: Bachelor's degree in Scientific Discipline preferably Microbiology Life Sciences Biological Sciences; Significant progressive experience in aseptic or bioburden control manufacturing environments (production, QA, validation) with demonstrated successful results in HA-regulated environment; 10+ years people management experience leading large globally distributed teams; Proven experience in aseptic/sterility assurance across pharma, biopharma, medical device; Experience leading or supporting regulatory inspections and PAIs including direct engagement with HA as senior technical SME; Demonstrated ability to lead through influence in complex global matrix organization; Executive presence with ability to communicate and influence at VP/SVP/C-Suite level internally and externally.
Qualifications: preferred: Advanced degree (MS, MPhil, PhD, MTD) in Microbiology Industrial Microbiology Clinical Microbiology Bacterial Toxicology; Experience working within or managing CMO partnerships in QA capacity; Experience in due diligence for CMO onboarding and new product launch; Experience with industry standard-setting activities through PDA, ISPE, PhRMA or equivalent.
Skills: Not explicitly listed; maybe we could omit Skills section if no specific skills list. The instruction: prefer a few substantive sections over many thin ones. So we could omit Skills.
Benefits: list benefits: comprehensive benefit plans – wellbeing support, retirement and financial protection benefits, insurance offerings (medical, dental, vision, life and disability); U.S.-based exempt employees eligible for Flexible Time Off (FTO) paid time off without set accrual limit, manager approval, plus 11 paid company holidays; Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours paid vacation annually for new hires (manager approval), 11 paid company holidays, 3 optional holidays; Depending on eligibility, employees may also have access to additional time-off benefits: paid sick leave, up to two paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs; Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day; U.S.-based job seekers can explore full benefit offerings at link (maybe we keep link? It's a reference; could keep as part of paragraph). We'll keep as prose.
Pay: compensation overview: $260,860 - $316,097 starting pay range for full-time employees; may also be eligible for additional discretionary incentive cash and stock opportunities; starting pay determined thoughtfully considering role nature, required skills, work location, schedule, knowledge/experience; final compensation guided by pay equity principles and applicable employment laws; compensation programs reviewed ongoing and may be adjusted.
Schedule: Not explicit; we have travel 30-50%; work models; but schedule not given. Could we treat travel as schedule? Probably not. Safer to omit Schedule.
Now produce HTML fragment:
About the role
... paragraphs ...
Responsibilities
- ... each responsibility ...
Requirements
- ... each required qualification ...
Qualifications
- ... each preferred qualification ...
Benefits
... benefits paragraph ...
Pay
... compensation paragraph ...
We must not include empty sections. Now craft content precisely, preserving details. Let's write About the role paragraph: "At Bristol Myers Squibb, employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency. The purpose‑driven culture inspires the discovery, development, and delivery of innovative medicines to prevail over serious diseases, offering uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This role is the Executive Director, Microbiology Quality Sterility Assurance (MQSA), a pivotal global leadership position within BMS's Corporate Quality organization. It requires defining, owning, and governing the enterprise‑wide Contamination Control Strategy (CCS) as a living, risk‑based framework aligned with EU GMP Annex 1, FDA, and all applicable global regulatory standards, serving as the global Single Point of Contact for sterility assurance and microbiology quality matters. The position expects 30‑50% travel and follows a work model determined by its core responsibilities (site‑essential, site‑by‑design, field‑based, or remote‑by‑design)." We could also include the encouraging statement: "We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway." Might add as another sentence. Now Responsibilities: need to capture all bullet points from the posting. Let's extract each bullet from the responsibilities section: From "Strategic Leadership & Sterility Assurance Governance": - Define, own, and drive BMS's Global Sterility & Microbiology Assurance Strategy, ensuring alignment across all manufacturing sites, CMOs, MS&T, GTS and PD partners - Serve as the primary executive-level contact for contamination control and sterility assurance across Operations, Engineering, MS&T, and PD - Embed control contamination and aseptic assurance strategy and aseptic-by-design principles into future processes and product development programs - Lead remediation plans following regulatory observations, ensuring proactive installation of appropriate aseptic assurance standards (QMS and standard work) across the business - Champion continuous improvement initiatives including KPI trending and capability development in aseptic and sterility assurance domains and process confirmations - Own and periodically review BMS's Global CCS as a living document, ensuring it reflects current regulatory requirements - Establish, own, and govern BMS's global sterility/aseptic assurance and CCS performance metrics framework, including KPI definitions, network-level escalation thresholds, trend analysis, and executive-level reporting cadence From "CMO & External Partner Management": - Support any implementation of BMS's Sterility Assurance Strategy - Lead CMO support in establishing and executing annual Contamination Control Strategies (CCS) and Aseptic/Sterility Assurance Roadmaps - Partner with CMOs for KPI analysis, trending, escalation, and gap assessments versus BMS standards (GQPs, QMS, FDA Guidance, etc.) - Conduct due diligence activities during onboarding of new CMOs - Drive alignment in ways of working and standard operating procedures between all CMO partners in aseptic/sterility assurance subjects From "Microbiological Quality & Technical Oversight": - Provide deep technical oversight of microbiological controls across pharmaceutical, biopharmaceutical, cell therapy, radiopharmaceutical and drug product manufacturing operations - Lead the identification, qualification, and validation of terminal sterilization suppliers - Provide expert technical guidance across product design, process controls, and organizational capabilities with a focus on microbiological controls - Drive the adoption of advanced analytics, digital environmental monitoring tools, and data-driven risk assessment approaches to enhance contamination surveillance and EM trending across the network - Lead or oversee complex cross-site microbiological investigations, CAPA development, and systemic remediation efforts, ensuring robust root cause analysis and sustainable corrective actions From "Regulatory & Compliance": - Maintain in-depth knowledge of global regulations, guidance documents, and industry best practices related to sterility assurance, including: EU GMP, FDA, WHO, PDA, ASTM, ISPE, PhRMA, and BMS internal standards - Support review of regulatory filings related to sterility assurance and microbiology - Lead or actively support sterility assurance-related regulatory inspections globally, including direct engagement with FDA, EMA, MHRA, and other Health Authorities - Lead assessment and adoption of new or updated regulations (