Executive Director, Quality Assurance Microbiology

We need to output HTML fragment with 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 as heading. Must not include Job ID etc. Must remove boilerplate like EEO, etc. Must preserve all substantive info. We need to parse the posting. Content: - Intro: "Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Executive Director, QA Microbiology who leads the strategy, design, and operational execution of Regeneron's GMP contamination control program across aseptic and low-bioburden biopharmaceutical manufacturing operations. This individual provides technical and operational direction to ensure robust environmental control, sterility assurance, and microbial contamination risk management across the network, driving compliance with global regulatory expectations for sterile and non-sterile product manufacturing. This position guides functional areas in support of compliance and business objectives, ensures the contamination control strategy remains current with evolving industry and regulatory expectations, and serves as the key liaison with operational microbiology and manufacturing subject matter experts across the lines of business." - "When & where: Location: East Greenbush, NY Work model: Monday-Friday, 8am-4:30pm" - "Discover your role:" then bullet list of responsibilities (starting with "Design, implement, and continuously improve a holistic Contamination Control Strategy (CCS) grounded in sound microbiological science, aseptic processing principles, and applicable quality, regulatory, and legal requirements." etc.) - Then "This role requires:" then list of requirements (education, experience, etc.) - Then "#REGNQA Does this sound like you? Apply now..." (application instruction, remove) - Then EEO boilerplate (remove) - Then "Where required, we will provide reasonable accommodation..." (EEO/accommodation, remove) - Then "Where necessary, we disclose salary ranges..." (benefits description) This is about 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." - Then "For additional information about Regeneron benefits in the U.S., please visit ..." (link, maybe keep as part of Benefits? It's a link but we can keep as prose.) - Then "For other locations, additional information will be provided during the recruitment process." (maybe keep) - Then "If you have any questions, please speak with your recruiter." (application instruction, remove) - Then "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." (maybe part of Schedule? Actually schedule is given earlier: Monday-Friday, 8am-4:30pm. This is about onsite expectation, could be part of Schedule or maybe we can include as part of Schedule? But schedule already defined. This is extra about onsite expectation; we could include in Schedule section? But schedule section should contain schedule specifics. The onsite expectation is not schedule but location expectation. Could be part of "When & where". We have location and work model. Could add a sentence about onsite expectation. - Then "As part of the recruitment process, certain background checks may be conducted..." (remove as boilerplate? It's about process, maybe not needed. It's not EEO but still procedural. Might be considered boilerplate; but it's substantive? It's generic. Likely remove. - Then "For jobs in Canada: this posting is for an existing position. Salary Range (annually)" (maybe part of Pay? It mentions salary range but not actual numbers. It says "Salary Range (annually)" but no numbers. According to rule: do NOT create Pay/Schedule/Benefits sections unless posting actually states them. It states there is a salary range but does not give numbers. It says "Salary Range (annually)" but no actual range. That's placeholder? It's not a specific range. So we should not create Pay section because no actual numbers given. However we could include a short paragraph about salary range being disclosed? The rule: never emit a heading followed by filler/placeholder text (e.g., "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Here it says "Salary Range (annually)" but no numbers; that's essentially placeholder. So we should not create Pay section. - Benefits: we have description of total rewards package. That's substantive. So we can include Benefits section. - Schedule: we have "Work model: Monday-Friday, 8am-4:30pm". That's specific schedule. So we can include Schedule section. - About the role: we have introductory paragraph. Could be About the role. - Responsibilities: the list after "Discover your role:" includes many items. We'll put those as

• . - Requirements: after "This role requires:" includes education, experience, etc. We'll put as Requirements. - Qualifications: maybe overlapping with Requirements. But we could separate Qualifications as advanced degree preferred etc. However the posting lumps education and experience together. We could treat Requirements as the list, and Qualifications maybe not needed. But we need to decide sections to include. The instruction: Prefer a few substantive sections over many thin ones. So we could combine Requirements and Qualifications into one section called Requirements (or Qualifications). But we have both headings allowed. We could include Requirements and Qualifications if there is distinct content. The posting includes "Bachelors degree ... (advanced degree preferred)" and then experience requirements. That's both qualifications and requirements. Could split: Qualifications: education, advanced degree preferred. Requirements: experience, expertise, etc. But we need to avoid thin sections. Might be okay to have both. - Skills: maybe we can extract skills like "Expert-level understanding of global regulatory expectations", "Proven track record leading root cause investigations", "Demonstrated ability to apply Quality Risk Management tools", etc. Those are more like qualifications/requirements. Could be part of Requirements. Given the instruction to prefer few substantive sections, we could have: About the role, Responsibilities, Requirements, Benefits, Schedule. That's five sections. We must not include Pay. We must not include Job ID etc. We must not include boilerplate EEO etc. We must preserve all substantive info: location, work model, responsibilities list, requirements list, benefits description. We need to ensure we don't lose any substantive detail from responsibilities and requirements. Let's extract responsibilities list: From "Discover your role:" until before "This role requires:" (the paragraph after that). Let's copy: - Design, implement, and continuously improve a holistic Contamination Control Strategy (CCS) grounded in sound microbiological science, aseptic processing principles, and applicable quality, regulatory, and legal requirements. - Provide expert vision in environmental monitoring (EM) programs, cleanroom classification, personnel qualification, gowning practices, and aseptic process simulation (media fill) performance across manufacturing sites. - Influence root cause investigations and risk assessments for microbial excursions, sterility failures, and environmental monitoring deviations, ensuring timely, science-based corrective and preventive actions. - Monitor contamination control program performance using meaningful operational metrics (e.g., EM trends, excursion rates, media fill success rates) and demonstrate a commitment to continuous improvement. - Embed quality risk management (QRM) tools such as FMEA and contamination risk mapping within microbiology and aseptic operations to proactively identify and mitigate contamination vectors. - Maintain current expertise in evolving regulatory expectations (e.g., EU Annex 1, FDA Aseptic Processing Guidance, USP , PIC/S) and proactively integrate emerging requirements into the contamination control program. - Apply quality and risk management tools to make timely, science-based decisions that protect patient safety and product sterility. - Partner closely with QA Operations, Manufacturing, Facilities/Engineering, and Microbiology Lab functions to translate contamination control strategy into robust, compliant aseptic practices on the floor. - Serve as the senior microbiological and contamination control decision-maker, exercising sound judgment under pressure to ensure product safety and efficacy. - Represent Regeneron as the subject matter authority on contamination control and sterility assurance to internal leadership, regulatory agencies, and corporate/external partners. - Translate contamination control vision and strategy into executable, resourced action plans across the manufacturing network. - Ensure the Contamination Control Strategy is transparent, well-documented, and that the broader organization is engaged and accountable for its execution. - Establish high standards for performance management and accountability to achieve microbiological, sterility assurance, and organizational objectives. That's all. Now requirements list: From "This role requires:" until before "#REGNQA". Let's extract: - Bachelors degree in Microbiology, Molecular Biology, Biology, Pharmaceutical Sciences, or related scientific discipline (advanced degree preferred), or equivalent combination of education and experience, - and the following amount of progressive experience in pharmaceutical/biopharmaceutical microbiology, sterility assurance, or contamination control, including significant leadership experience in aseptic manufacturing environments, for each level: - Senior Director 15+ years - Executive Director 18+ years - Level will be determined based on experience - Deep operational expertise in aseptic processing and low-bioburden manufacturing, including cleanroom design/classification, HVAC airflow principles, personnel and material flow, gowning qualification, and aseptic technique. - Demonstrated hands-on ownership of a Contamination Control Strategy (CCS), including environmental monitoring program design, trending, and risk-based EM site selection. - Strong working knowledge of aseptic process simulation (media fill) design, execution, and failure investigation. - Expert-level understanding of global regulatory expectations and guidance, including EU Annex 1 (2022 revision), FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing, USP , PIC/S, and ISO 14644. - Proven track record leading root cause investigations, deviation management, and CAPA for microbial contamination events, sterility test failures, and environmental excursions. - Demonstrated ability to apply Quality Risk Management tools (FMEA, fishbone, risk mapping) to contamination control and microbiological decision-making. - Experience representing microbiological/contamination control positions directly to health authorities during inspections (FDA, EMA, MHRA) with a strong inspection track record. - Demonstrated success partnering cross-functionally with Manufacturing, Facilities/Engineering, QA Operations, and Microbiology Labs to translate strategy into floor-level execution. - Strong people leadership experience, including building and developing high-performing technical teams and driving accountability across a matrixed organization. - Excellent judgment and composure in high-stakes, time-sensitive decision-making affecting product disposition and patient safety. - Executive presence and communication skills suited to representing the company with regulators, corporate partners, and senior leadership. We should keep all that. Now benefits: description: "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." Also maybe the line: "For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/." Could keep as link. Also "For other locations, additional information will be provided during the recruitment process." We'll include that as part of Benefits. Now schedule: "Location: East Greenbush, NY Work model: Monday-Friday, 8am-4:30pm". Also maybe note onsite expectation