JOB SUMMARY
The Director of Global Sterility Assurance is responsible for developing, planning, and executing the sterilization, clean room, contamination control strategy, controlled manufacturing environment, and associated product, process and microbiological testing strategies in alignment with customer and global regulatory requirements. This role is responsible for the policies and procedures associated with the sterility assurance program and ensures these procedures meet state-of-the-art expectations according to industry best practices and requirements. Technical and thought leader and subject matter expert in microbiology, aseptic practices/behaviours and sterilization methodologies and practices. Participates in and supports internal, customer, and regulatory authority GxP inspections and audits and associated audit responses, when needed. Other responsibilities include analyzing global intelligence, implementing projects that enhance sterility assurance and aseptic practice compliance, interacting with peers in industry to ensure best practices across facilities, and liaising with applicable centers of excellence groups, such as regulatory compliance, quality systems, and operations. This position advises and supports sites in devising and executing remediation actions associated with clean room activities, aseptic practices and sterilization concerns to ensure compliance to regulatory and customer requirements and expectations. This role understands the business needs (i.e., current and future) to determine the framework of sterility assurance processes that are both efficient and adaptable to business and customer needs.

LOCATION

This position will be based on-site in Hunt Valley, Maryland,  U.S., and support sites globally, progressing to a remote/global role after an agreed period of time.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Assist and support in developing and maintaining regulatory documentation – collect and coordinate information and support preparation of regulatory documentation for customer submissions (i.e., sterilization validation reports, EMPQ, Aseptic Process Simulation).
• Provide early guidance to support the policies and process with the quality management system to promote the understanding and compliance related to sterility assurance and aseptic processing activities.
• Expertise in design, qualification, and control of clean room facilities and critical utilities.
• Provide early guidance and solutions concerning product and process evaluations (e.g., potential compliance concerns, customer escalations) and ensure proper and appropriate reporting.
• Ensure corrective measures meet reliability standards and that documentation is compliant with requirements.
• Provide guidance on solutions to resolve and prevent recurrence of identified issues.
• Conduct periodic research of global issues and disseminate information to Quality, Operations, and Engineering departments and to senior management.
• Implement continuous improvement of sterility assurance and aseptic processes and procedures to ensure adherence to rapidly changing global regulatory requirements.
• Experience in data analysis and statistical evaluation and trending of environmental monitoring microbiological data.
• Strong knowledge of standards, including Association for the Advancement of Medical Instrumentation (AAMI), European Committee for Standardization (CEN) and ISO. Competency in multiple industrial terminal sterilization methods (e.g., EO, gamma, electron beam, moist heat, dry heat).
• Strong knowledge and experience on Aseptic processes, practices and controls, and associated standards including ISO13408, FDA cGMP and EU GMP Annex 1 requirements.
• Thorough understanding and knowledge of applicable regulations (ISO 13485, ISO 14971, and 21 CFR Part 820.
• Lead complex investigations about microbiological or aseptic deviations in manufacturing and/or in laboratory results. Monitor laboratory out of trend (OOT) and out of specification (OOS) investigations.
• Establish a global system for routine review of sterility assurance system data, including internal/external audit execution and results to determine compliance gaps and associated mitigation plans on a global level.
• Collaborate with stakeholders to ensure inspection readiness and proper coordination during the course of inspections.
• Participate in Quality System Management Reviews and assist the sterility assurance team in preparation of data and analyses.
• Experience in microbiology, sterility assurance (terminal aseptic, and reprocessing) and aseptic processing.
• Strong knowledge in environmental controls systems and practices in medical device and/or pharmaceutical operations.
• Proactively engage with stakeholders to build a progressive and integrated sterility assurance function.
• Understand the business, consider current trends in the medical device and pharmaceutical industry, and have the vision to develop sterility assurance and aseptic processes that are efficient and adaptable.
• Create, deliver, and evaluate educational material to appropriate levels of management.
• Comply with and follow all procedures within the company security policy.
• Perform other duties and responsibilities as assigned.

FUNCTIONAL MANAGEMENT RESPONSIBILITIES

• Reports to Global Quality and Regulatory Management. Direct supervisor:  VP, Quality & Regulatory, Healthcare.
• Job is directly responsible for managing other employees (e.g., hiring/termination and/or pay decisions, performance management). Job title example(s) of employees directly supervised:  Manager/Supervisor.

JOB QUALIFICATIONS

KNOWLEDGE REQUIREMENTS

• Experienced leader with proven history designing and implementing sterility assurance and aseptic practice policies and procedures and establishing and maintaining a sterility assurance program strategy for Jabil, interfacing with customer and regulatory professionals.
• Proven experience participating in customer audits, health authority inspections, and Registrar / Notified Body audits.
• Ability to direct and manage an international team and experience in assisting global manufacturing sites.
• Responsible for building strong departmental skill sets and compliance/improvement culture with direct and indirect reports.
• Ability to work effectively in a global, matrixed environment required. Strong interpersonal skills.
• Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint).
• Excellent written and oral communication skills with attention to detail required.
• Fluent in English. Additional language proficiencies are an asset (e.g., Spanish, German).

EDUCATION & EXPERIENCE REQUIREMENTS

• Bachelor’s degree in Microbiology or related Science required; Master’s degree preferred.
• Minimum of 15+ years work-related experience and 7+ years minimum in a role in a regulated organization with a focus in microbiology and sterile product manufacturing within medical devices / in vitro diagnostics and/or pharmaceutical products.
• Knowledge and experience with data-driven approach to continuous improvement.

The pay range for this role is £98,851 - £177,655. Job-related, non-discriminatory factors used to determine the actual offered rate include qualifications and experience, geographic location, education, external market data, and consideration of internal equity.

As part of the total rewards package, this position is eligible for a short-term incentive based on performance. In addition, Jabil offers benefits to enhance your health, wealth and resilient self. These include medical, dental, and vision insurance plans; 401(k) retirement plan and employee stock purchase plan; and paid time off.

BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver’s license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact your local police department. Any scam job listings should be reported to whatever website it was posted in.

Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, age, disability, genetic information, veteran status, or any other characteristic protected by law.

Accommodation Statement

If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.