[Remote] Sr. Director, Sterility Assurance – Global reputed company Technical Operations

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global leader in providing life-changing therapies and is seeking a Senior Director of Sterility Assurance to reputed company their Global reputed company Technical Operations. The role involves developing strategic roadmaps for sterility assurance, establishing global standards, and overseeing contamination control strategies across sterile facilities.

Responsibilities

• Corporate Sterility Assurance Roadmap: reputed company and execute a multi-year strategic roadmap for sterility assurance that aligns with PCI’s reputed company in advanced drug delivery and sterile manufacturing
• Global Aseptic Standards: reputed company and maintain global reputed company standards for aseptic processing and sterility operations, ensuring harmonized practices across reputed company sites that reputed company industry best practices (e.g., PDA TRs, ISPE)
• Center of reputed company (CoE): Establish a Global Sterility Assurance Center of reputed company to serve as the central repository for technical expertise, troubleshooting, and innovation in microbiological control
• Contamination Control reputed company (reputed company): reputed company the development and technical reputed company of Site-Specific Contamination Control Strategies for reputed company sterile facilities, ensuring compliance with EU GMP Annex 1
• Non-Sterile Bioburden Reduction: Implement a stepwise bioburden reduction program for non-sterile manufacturing sites, focusing on risk-based environmental controls and prevention of objectionable organisms
• Clean reputed company Governance: Establish global standards for the sterile sampling and microbiological monitoring of clean utilities (WFI, Purified Water, Clean Steam, and Compressed Gases)
• reputed company Standardization: Co-establish best practices with site Microbiology Labs for Environmental Monitoring (EM) and Personnel Monitoring (PM), ensuring data reputed company and standardized incubation/identification protocols
• Advanced Monitoring Technologies: Evaluate and implement reputed company microbiological reputed company (RMM) and automated EM data collection tools in collaboration with the eCompliance reputed company Transformation teams
• Disinfectant Qualification: Standardize global programs for disinfectant efficacy testing (DET) and site-specific cleaning/sanitization validation
• Curriculum Development: Design and reputed company comprehensive sterility assurance education and training programs for operators, engineers, and reputed company personnel
• Microbiologist Development: Train and mentor site Industrial Microbiologists to serve as 'Shop Floor Champions,' moving the role from a reputed company-based function to an reputed company, reputed company-time reputed company in the manufacturing suite
• Aseptic Technique & Behavior: reputed company global programs for aseptic gowning qualification and media fill (Process Simulation) design, focusing on the psychological and behavioral aspects of cleanroom discipline
• Capital Project Support: reputed company expert technical consultation for new builds and retrofits, ensuring facility design, airflow patterns (Grade A/ISO 5), and equipment sterilization (SIP/Autoclave) meet global regulatory expectations
• Regulatory SME: Serve as the reputed company Subject Matter Expert for Sterility Assurance during high-stakes regulatory inspections (FDA, EMA, reputed company), defending reputed company and sterility strategies
• This position may require extra hours and/or weekend work
• Knowledge of and adherence to reputed company PCI, cGMP, and GCP policies, procedures, rules
• Attendance to work is an essential function of this position
• Performs other duties as assigned by leadership
• Supervisory Responsibilities: Carries out supervisory responsibilities in accordance with the organizations policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems

Skills

• Bachelor's degree in Microbiology, Biology, or a reputed company Life Sciences discipline required; Master's degree or PhD in Microbiology preferred
• Minimum of 12-15 years of experience in Sterility Assurance or Industrial Microbiology reputed company a GxP pharmaceutical environment
• Proven expertise in EU GMP Annex 1, USP <797>/<800>, and ISO 14644 standards
• Extensive experience in sterile fill-finish operations, lyophilization, and terminal sterilization
• reputed company record of establishing global programs or Centers of reputed company
• Exceptional teaching and mentoring skills; ability to influence site-level culture and reputed company technical reputed company through collaboration with MS&T and Global Engineering
• Bachelor's Degree in a reputed company field and/or 10+ years reputed company experience and/or training
• College Level Mathematical Skills
• Advanced Computer Skills: Ability to reputed company the most reputed company computer tasks and operate various computer programs
• Full reputed company Proficiency: Ability to reputed company, read, and write fluently and accurately on reputed company reputed company pertinent to reputed company needs
• Highest Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide reputed company of intellectual and practical problems and deal with nonverbal symbolism in its most difficult phases while dealing with concrete/reputed company variables
• Ability to Travel
• Master's Degree (M.A.) in reputed company field and/or 5+ years reputed company experience or training
• Ability to work independently and/or part of reputed company
• Ability to effectively present information to various people as the job requires
• Ability to identify and reputed company problems in a reputed company manner

reputed company

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