Sr. Director, Aseptic Operational Support

We need to output HTML fragment with headings

for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. The posting includes a description about company culture at start (maybe "About the role"? Actually there is a paragraph about BMS purpose, etc. That could be "About the role" or maybe "About the company". The instruction says use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we need to map content accordingly. We must not repeat job title as heading. No Job ID/requisition numbers as headings; we can fold minor metadata into short

or drop it. The posting includes "R1606481 : Sr. Director, Aseptic Operational Support" at end. That's job ID and title. We should not put that as heading; we can drop it or put in a short

maybe but better to drop as minor metadata. We need to preserve all substantive information, no invention. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, application instructions. So we need to cut out sections like "Supporting People With Disabilities", "Candidate Rights", "Data Protection", "How We Work", etc. Those are boilerplate/EEO etc. Also "Benefits" section we need to keep if there is real specific content. There is a Benefits paragraph describing benefits. That's substantive. So we keep Benefits section. Pay: there is compensation overview with salary ranges for locations. That's specific. So we include Pay section. Schedule: does posting mention schedule? Not really. It mentions flexible time off, but not schedule like full-time/part-time. There's mention "full-time employees (FTE)". That's schedule info? Could be considered schedule: full-time. But the instruction says never create Pay/Schedule/Benefits sections unless posting actually states them. It does state full-time employees (FTE). That's schedule info. So we could include Schedule section with that detail. However we need to see if there is any other schedule info like shift, remote, etc. There's "How We Work" section describing work models but that's boilerplate? It's about work models but maybe considered substantive? It says "Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities." That's somewhat specific but maybe considered generic. The instruction says remove duplicated lines, boilerplate. This might be considered generic but still substantive? It's about work models. Might be okay to include under Schedule? But schedule section is about work schedule (full-time/part-time, shift). The work models could be considered schedule? Not exactly. Safer to not create Schedule section unless explicit schedule info like "full-time", "part-time", "shift". We have "full-time employees (FTE)". That's enough to mention schedule. So we can include Schedule with that line. Responsibilities: we have many bullet-like paragraphs under "Key Responsibilities" with multiple subheadings: Enterprise Governance & Leadership, Strategy, Roadmap & Performance Monitoring, Cross-Site Harmonization & Knowledge Management, Technical Authority & Contamination Event Leadership, Environmental Monitoring Program Ownership, CMO Oversight — Selection Process, Qualification & Ongoing Governance, Gowning, Personnel Flow & Aseptic Facility Design Guidance. Those are responsibilities. We need to output as

• for any list of duties/requirements/benefits. So we need to turn each responsibility into list items. Could group under subheadings? The instruction only says use

  for section headings (like Responsibilities). Inside that we can have

  • items. We should not add extra headings inside? Not prohibited but we can keep as plain list items. However we might lose some structure. But it's okay. Requirements: The posting has "Qualifications & Experience" with Education Required, Experience, etc. That's qualifications. So we put that under Requirements or Qualifications? The instruction lists both Requirements and Qualifications as possible headings. We need to decide which to use. Usually Requirements = mandatory, Qualifications = preferred? But we can combine. Since they have both Education Required and Experience etc under "Qualifications & Experience". We'll treat that as Qualifications section. Requirements maybe we could leave empty or not include. Better to include Qualifications section with that content. Could also include Requirements as same but we should not create empty sections. So we will have Qualifications. Skills: there is "Skills & Competencies" section with bullet points. So we include Skills. Benefits: we have Benefits paragraph. Pay: compensation overview. Schedule: maybe we include note about full-time. About the role: The initial paragraph about BMS purpose, culture, etc. That's about the role/company. We'll put as About the role. Now we need to strip boilerplate: Remove "Supporting People With Disabilities", "Candidate Rights", "Data Protection", "How We Work", etc. Also remove lines about "We hire for skills and capabilities..." maybe keep? That's part of Qualifications? It's a statement encouraging apply; could be considered boilerplate but it's substantive? It's a generic encouragement. Might be considered boilerplate but not EEO. The instruction says remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The "We hire for skills and capabilities..." is not exactly those categories, but it's more of a generic encouragement. Might be okay to keep? It's not a list item. Could be placed under Qualifications as a note. But it's not a requirement. Might be considered filler. Safer to drop it as it's not a specific requirement. However it's part of the posting; but instruction says preserve ALL substantive information; do NOT invent or summarize away detail. That line is substantive? It's a statement encouraging applicants. Might be considered boilerplate but not explicitly listed. I'd keep it maybe as a

    under Qualifications. Also need to drop duplicated lines: I don't see duplicates. Now we need to output only HTML fragment, no /, no markdown fences. Let's craft:

    About the role

    At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

    Responsibilities

    • Enterprise Governance & Leadership: Govern enterprise aseptic and microbial control practices, including the design and management of escalation pathways, cross-functional forums, and structured decision frameworks; provide executive-level leadership for Quality Council and EAC activities related to sterility assurance and contamination control; define and maintain clear thresholds for escalation of contamination events, systemic risks, and critical microbial control deviations across sterile and non-sterile manufacturing sites; establish and own enterprise-wide policies, standards, and procedures governing aseptic operations, environmental monitoring, and microbial control programs.
    • Strategy, Roadmap & Performance Monitoring: Define the enterprise aseptic, microbial control, and sterility assurance roadmap — inclusive of short-term priorities and long-range capability-building strategies; establish enterprise KPIs and a comprehensive performance monitoring strategy to measure program effectiveness, site compliance, and continuous improvement outcomes; lead enterprise trend detection, signal monitoring, and recurring event analysis across both sterile and non-sterile manufacturing environments; translate performance data and risk signals into actionable strategies and executive-level insights.
    • Cross-Site Harmonization & Knowledge Management: Drive cross-site harmonization of aseptic and microbial control practices across the global manufacturing network; build, facilitate, and sustain a Community of Practice (CoP) for sterility assurance and contamination control, enabling knowledge sharing, peer learning, and best practice dissemination; lead enterprise knowledge management initiatives — capturing learnings from deviations, audits, and industry trends and converting them into prevention actions and training content; champion a culture of continuous improvement and scientific rigor across both sterile and non-sterile manufacturing communities.
    • Technical Authority & Contamination Event Leadership: Serve as the enterprise technical authority for all matters related to sterility assurance, contamination control, aseptic processing, and microbial risk management; provide aseptic and contamination control expertise in technology transfers, PPQ readiness and commercialization activities across internal and external manufacturing sites; lead governance and oversight of high-risk, systemic, or cross-site contamination events — including Subject Matter Expert (SME) impact assessments, root cause investigations, and CAPAs; provide authoritative technical guidance on sterile and non-sterile contamination events, ensuring scientifically sound and regulatory-aligned conclusions; represent BMS as the senior technical voice in regulatory inspections, agency interactions, and industry forums related to aseptic operations and microbial control.
    • Environmental Monitoring Program Ownership: Define enterprise environmental monitoring (EM) program requirements, including: alert and action limit standards, sampling plan design and review, monitoring frequency standards, personnel sampling requirements; ensure EM program requirements are consistently applied across sterile manufacturing environments and extended appropriately to relevant non-sterile environments; lead periodic review and modernization of EM standards in alignment with evolving regulatory expectations and industry best practices (e.g., PDA, USP, EU GMP Annex 1).
    • CMO Oversight — Selection Process, Qualification & Ongoing Governance: Monitor and trend enterprise CMO aseptic and microbial control performance indicators and risk signals; capture and disseminate learnings as enterprise-level prevention actions; provide technical input for CMO escalations, deviations, investigations, and technology transfers involving aseptic or microbial control considerations; conduct risk-tiered CMO assessments for aseptic practices and microbial control, establishing differentiated oversight models based on risk profile and performance history; design and implement standardized CMO oversight tools, dashboards, and decision trees to enable consistent and data-driven monitoring of aseptic and microbial control performance across the CM.
    • Gowning, Personnel Flow & Aseptic Facility Design Guidance: Govern and provide expert guidance on gowning qualification programs and gowning sequence standards across aseptic and controlled manufacturing operations; define optimal personnel, material, and waste flow strategies for aseptic and controlled manufacturing environments to minimize contamination risk; support facility design reviews and cleanroom classification initiatives, providing expert input on layout, pressure differentials, and contamination control by design.

    Qualifications

    Education Required: Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline.

    Experience: 15+ years of progressive pharmaceutical industry experience in microbiology, sterility assurance, contamination control, or aseptic processing; minimum 8–10 years in senior leadership roles with enterprise-level accountability for quality, compliance, or regulatory strategy; deep experience working in manufacturing facilities across multiple manufacturing modalities, including small molecule, biologics, cell therapy, or gene therapy; demonstrated expertise in global regulatory frameworks (FDA 21 CFR Parts 210/211/600, EU GMP Annex 1, Part IV for Advanced Therapies, ICH Q9/Q10, USP //, PIC/S, and other applicable guidance); proven experience leading or supporting regulatory inspections (FDA PAI/GMP, EMA, MHRA, or equivalent); experience governing CMO/CDMO quality relationships and aseptic compliance requirements; track record of successfully leading enterprise-wide harmonization and change management programs.

    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.

    Skills

    • Enterprise thinking: Ability to translate site-level data into network-wide strategy and risk management decisions