Executive Director, Microbiology Quality Sterility Assurance

We need to output HTML fragment with sections: h3 headings for sections present: About the role? The posting includes Position Summary, Key Responsibilities, Required: Qualifications & Experience, Preferred, Compensation Overview, Benefits, How We Work, Supporting People With Disabilities, Candidate Rights (but we must remove EEO/legal boilerplate). Also we should drop navigation/cookie etc. Also we should not repeat job title as heading. The page already shows it, so we don't add heading for job title. We need to include sections only when posting has real specific content. We have content for Position Summary (we can treat as About the role maybe). The instructions: use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should map sections accordingly. We have Position Summary -> could be About the role. Key Responsibilities -> Responsibilities. Required: Qualifications & Experience -> Requirements (or Qualifications). We'll use Requirements. Preferred -> maybe Skills? But we can include as Qualifications? Actually Preferred is additional qualifications; we could include under Requirements or Skills. The instruction list includes Skills as a possible heading. We'll put Preferred under Skills. Compensation Overview -> Pay. Benefits -> Benefits. How We Work -> maybe Schedule? But it's about work models; not schedule. Could be omitted if not matching headings. The instruction says include a section ONLY when posting has real specific content for it — never emit heading followed by filler. We have content for How We Work (work models). There's no standard heading for that; we could omit or maybe treat as Schedule? Not appropriate. Better to omit if not matching allowed headings. But we could still include a heading like "Work Model" but not in allowed list. The instruction says use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings, but says use those for section headings (e.g.). Likely we should stick to those headings. So we can omit How We Work. Supporting People With Disabilities and Candidate Rights are EEO/legal boilerplate; we should remove. Thus we will output sections: About the role (Position Summary), Responsibilities (Key Responsibilities), Requirements (Required: Qualifications & Experience), Skills (Preferred), Pay (Compensation Overview), Benefits (Benefits). We must use

• for any list of duties/requirements/benefits. So we need to convert lists into
  • . The responsibilities are many bullet-like sentences separated by line breaks. We'll wrap each responsibility as
  • . Similarly for qualifications (required) list. Preferred list as
  • . Benefits list as
  • . Pay: just a paragraph with the range. We must preserve all substantive information; do not invent or summarize away detail. So we need to keep the text exactly as given, but we can format into HTML. We must not include boilerplate like "We hire for skills and capabilities..." etc? That's part of posting but not a section; it's after Compensation Overview? Actually after Compensation Overview there is a line: "BMSBL 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 a statement; we should keep it? It's not boilerplate; it's a motivational note. Should we keep? It's substantive. We'll include it maybe as a paragraph under Pay or after? Could be part of About the role? It's more general. We'll keep as a paragraph after Pay maybe. Also there is "U.S.-based exempt employees are eligible for Flexible Time Off (FTO)..." That's part of Benefits; we keep. We must not include application instructions, etc. There's none. We must not include Job ID/requisition numbers. Now craft HTML. We'll start with

    About the role

    then

    with Position Summary text. Then

    Responsibilities

    then
    with each responsibility as
    • . Need to split responsibilities: The text under Key Responsibilities includes several paragraphs each starting with a bold heading? Actually the text: "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 programsLead remediation plans following regulatory observations, ensuring proactive installation of appropriate aseptic assurance standards (QMS and standard work) across the businessChampion continuous improvement initiatives including KPI trending and capability development in aseptic and sterility assurance domains and process confirmationsOwn and periodically review BMS's Global CCS as a living document, ensuring it reflects current regulatory requirementsEstablish, 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 CMO & External Partner Management Support any implementation of BMS's Sterility Assurance StrategyLead CMO support in establishing and executing annual Contamination Control Strategies (CCS) and Aseptic/Sterility Assurance RoadmapsPartner 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 Microbiological Quality & Technical Oversight Provide deep technical oversight of microbiological controls across pharmaceutical, biopharmaceutical, cell therapy, radiopharmaceutical and drug product manufacturing operationsLead 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 controlsDrive the adoption of advanced analytics, digital environmental monitoring tools, and data-driven risk assessment approaches to enhance contamination surveillance and EM trending across the networkLead or oversee complex cross-site microbiological investigations, CAPA development, and systemic remediation efforts, ensuring robust root cause analysis and sustainable corrective actions 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 standardsSupport review of regulatory filings related to sterility assurance and microbiologyLead 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 (e.g. Annex 1)Ensure CMOs and internal sites maintain inspection readiness at all times Business Planning & Capital Strategy Apply understanding of business planning, capital planning, and business case development to help drive aseptic/sterility assurance investment decisionsBalance technical, compliance, and business attributes in the decision-making process, demonstrating strong business acumenProactively engage and align stakeholders, capabilities, and resources to achieve company objectivesSupport identification of business solutions to enhance aseptic and low-bioburden manufacturing processes, improving robustness and operational efficiency External Advocacy Lead or proactively influence external aseptic/sterility assurance trade associations and industry working groups (e.g., PDA, ISPE, PhRMA)Represent BMS and proactively influence external scientific and regulatory forums, including Health Authority advisory panels and industry standard-setting bodiesAdapt and embed emerging best practices and industry innovations into BMS operations People Leadership & Capability Development Lead, inspire, and develop a high-performing, globally distributed team of sterility assurance and microbiology professionalsBuild the newly established central MQSA function from the ground up, defining team structure, roles, operating model, and ways of working in partnership with senior leadershipBuild aseptic/sterility assurance and microbiological capability across the broader BMS organization through delivery of training, coaching, and mentoring programsDevelop technical talent pipelines, supporting career growth and succession planning within the Quality functionEnergize and align cross-functional teams and business partners toward a shared quality visionFoster a culture of contamination prevention, quality ownership, and continuous learning across all sites and functions within the MQSA community of practice" We need to split into list items. Could treat each bold heading as a group; but we can just split by sentences? Better to keep each responsibility as a paragraph? The instruction: use
      • for any list of duties/requirements/benefits. So we need to make a list. We'll create
      • for each major responsibility area (the bold headings) and include the detailed sentences within each
      • . That seems reasonable. Thus list items: - Strategic Leadership & Sterility Assurance Governance: ... (all text after that heading until next heading) - CMO & External Partner Management: ... - Microbiological Quality & Technical Oversight: ... - Regulatory & Compliance: ... - Business Planning & Capital Strategy: ... - External Advocacy: ... - People Leadership & Capability Development: ... We'll preserve the text exactly as given (including punctuation). Ensure we don't lose any. Now Required: Qualifications & Experience: text includes bullet-like lines? It's a paragraph with line breaks. We'll make a list: each line after "Required:" maybe separate items: Bachelor's degree..., Significant and progressive experience..., 10+ years..., Proven experience..., Experience leading..., Demonstrated ability..., Executive presence... We'll split by line breaks. Preferred: lines: Advanced degree..., Experience working within..., Experience in due diligence..., Experience with industry standard-setting... We'll list. Pay: Compensation Overview paragraph. Benefits: The benefits paragraph includes multiple sentences; we can make a list: each benefit item? The text: "Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability). U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year. Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays. Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and 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 https://careers.bms.com/benefits" We can split into list items each sentence. Now also include the note "We hire for skills and capabilities..." after Pay maybe as a paragraph. Now produce HTML. Be careful to escape any HTML special characters like &, <, >. The text includes "&" in "PD/MS&T, GTS". Need to escape as &. Also "MS&T" includes &, need escape. Also "GTS". Also "FDA, EMA, MHRA". Also "WHO, PDA, ASTM, ISPE, PhRMA". Also "GQPs, QMS, FDA Guidance". Also "PD/MS&T". Also "MS&T". Also "PD/MS&T". Also "PD/MS&T". Also "PD/MS&T". Also "PD/MS&T". Also "PD/MS&T". Also "PD/MS&T". Also "PD/MS&T". Also "PD/MS&T". Also "PD/MS&T". Also "PD/MS&T". Also "PD/MS&T". Also "PD/MS&T". Also "PD/MS&T". Also "PD/MS