Staff Specialist, Global Product Safety and Compliance Technology Solutions (Finance)
Position Summary:
The Staff Specialist, Global Product Safety and Compliance Technology Solutions will drive Product Safety and Compliance technology improvements throughout all Illumina operations, as part of a highly innovative and collaborative business model. The Global Product Safety and Compliance Technology Solutions Staff Specialist will also serve as Illumina's subject matter expert for the Illumina Dangerous Goods (DG) Global Program, driving technical and regulatory requirements into operational and design guidelines.
This individual is responsible for managing and executing Product Safety and Compliance technology and systems strategy across all Illumina global locations, ensuring compliance with applicable laws and regulations, effective risk management, and EHS value creation.
The Global Product Safety and Compliance Technology Solutions Staff Specialist role will sit on the Global Environment and Product Stewardship team within the Global Environment, Health & Safety (EHS) function, working closely with regional EHS leaders in the development of Illumina global and regional policies, guidelines, standards, and best practices, including process improvements and incorporating requirements into enterprise-wide software and technology solutions and tools. The vision for Illumina is that every Illumina employee will be a leader in EHS. The Global Product Safety and Compliance Technology Solutions Staff Specialist will play a key role in helping Illumina to achieve this vision through the development and implementation of technology solutions that drive engagement around risk management and compliance.
All About You
Responsibilities:
- Design, develop, and implement global regulatory business processes and related technology solutions that deliver Product Safety risk management and compliance value to the organization.
- Serve as Illumina's subject matter expert for the Illumina Dangerous Goods (DG) Global Program, driving technical and regulatory requirements into operational and design guidelines and support the assessment and control of DG issues arising from varied global business operations. Expert level in hazardous materials transport classification and modes of transport regulations.
- Influence and help deliver the development of the EHS Environment and Product Stewardship strategy and technology roadmap.
- Lead and drive Product Safety and Compliance program and technology solutions design, development, and implementation including programs such as Safety Data Sheet (SDS) creation, Global Harmonization System (GHS) Labeling, Right to Know SDS Access for Employees, Hazard Communication, Substance Volume Tracking, TSCA, REACh, Dangerous Goods Management, Hazardous Substance Management.
- Author SDS for Illumina products and intermediates.
- Monitor, interpret, and assess existing or emerging Dangerous Goods laws, regulations, regulatory policy, and industry practices, determine operational and business impacts and develop and execute global DG and Product Safety technology strategies, programs, guidelines, policies, processes, systems, tools, training, best practices, and actions throughout the business to effectively manage applicable or relevant requirements, while driving the EHS mission, vision and strategy.
- Collaborate with Regional EHS teams and across departments to support the implementation of global DG strategies, programs, guidelines, policies, processes, systems, tools, training, best practices, and actions.
- Partner with the global supply chain function for collaboration on product compliance regulatory requirement knowledge including TSCA, REACh, chemical control inventories, RoHS, ingredient disclosure, FDA, etc.
- Demonstrate a thorough understanding of SAP methodology, principles, theories, data standards, concepts, and techniques.
- Prepare technology requirement documentation, as-is & to-be process maps, and identify solutions to program gaps, all that help meet the needs of global program risk management and compliance.
- Team lead role in implementation of EHS Product Safety & Compliance management systems enterprise software such as SAP in Illumina.
- Leading role on project teams to configure/deploy SAP EHS Product Safety and Compliance solutions; assist with SAP system configuration, integration, training, rollout, support, maintenance, and improvements.
- Assists in preparation of test plans, conduct testing validation, and support user acceptance testing (UAT).
- Provide knowledge transfer enablement through formal documentation and end-user training. Engage in system support and training documentation teams, prepare and present training to system users.
- Provide input to architecture, security, and data standards; ensure end-to-end solutions adhere to these standards.
- Translate global Product Safety and Compliance strategies into long- and short-term objectives via EHS action plans, projects or initiatives that effectively manages DG compliance and risk mitigation objectives with business objectives, operating plans, capital planning, resource staffing and budgeting.
- Manage and assess enterprise-wide impact of DG related activities to ensure lessons learned are realized and shared for future continuous improvement of DG programs.
- Partner with the Product Development Team to design and develop strategies, programs, guidelines, policies, processes, systems, tools, and training, needed to integrate effective DG Risk Management into our product design that benefit development, manufacturing, and supply chain operations.
- Support the assessment, selection, design, implementation, and maintenance of the Enterprise Information Management System EHS programs across all Illumina locations and operations.
- Participate in the global audit program that verifies ongoing compliance with global DG standards as well as local / regional regulatory requirements.
- Partner with stakeholders to engage all employees in grass roots DG programs and increase awareness.
- Influence, gather, analyze and document Product Safety and Compliance business requirements.
Requirements:
- A minimum of 8 years' experience managing Product Safety and Compliance programs including management of policies, standards, programs, systems, or procedures within a company that operates globally, preferably at a Biotech or Life Sciences company.
- Minimum 3 – 5 years SAP EHS PS / PC hands on experience.
- Minimum of 2 full life-cycle EHS technology implementations including all phases such as planning, defining requirements, design, build, test, and deployment.
- Experience in integration to 3rd party systems with SAP EHS components.
- Experience in definition of test scenarios and development of test cases and preparation of test data.
- Well versed with data loads for EHS objects.
- Demonstrated functional knowledge of DG and GHS classification system and global SDS and labeling requirements.
- Knowledgeable of EHS Product Safety and Compliance management software systems available on the market, including assisting clients with system rationalization and selection.
- SDS and label technology solution design & deployment desired. Prior SDS authoring experience in WERCS is a plus.
- Strong global supply chain product compliance regulatory requirement knowledge including TSCA, REACh, chemical control inventories, RoHS, ingredient disclosure, FDA, etc.
- Ideal candidate has both process manufacturing (chemicals sector) as well as discrete manufacturing business process and requirements demonstrated experience.
- The successful candidate will have hands on SAP EHS Product Safety solution functionality including the core specification database data model design (hierarchy, compositions, inheritance, value assignment, etc.), safety data sheet authoring and distribution (SDS), label authoring and generation (GLM), hazardous materials / dangerous goods classification and shipping (DG) and global product compliance / substance volume tracking (SVT) is desired.
- SAP EHS operations implementation experience including Incident Management, Environmental Management, Management of Change, and Health & Safety is significantly positive for candidates.
- Demonstrated broad technical and global regulatory experience in TSCA, EU REACh, KREACh, Prop 65, and able to effectively operate in a matrix organization to progress programs.
- Proven track record of developing and implementing DG and product safety compliance programs across global business unit lines, aligned with compliance requirements, risk profiles and business priorities to drive performance improvement.
- Strong experience in providing effective EHS regulatory, technical, engineering, management system knowledge and best practices in a global business.
- EHS Leadership skills that inspire others to desire and achieve EHS excellence.
- Professional certification preferred: CSP or CIH.
- Experience with VPP, OHSAS 18001, ISO14001, or 45001 management systems.
- Strong desire to champion EHS excellence throughout Illumina and drive innovative solutions to continuously improve EHS programs.
- Experience with enterprise EHS software systems design, process, communication, and implementation.
- Ability to influence the business at all levels of the organization.
- Strong capability to build collaborative and productive working relationships, teams, and networks with key internal and external stakeholder.
- Experience building strong partnerships with employees and developing a safety culture that is integrated throughout all levels of the organization.
- Experience leading and motivating cross-functional teams.
- Energetic and positive enthusiasm disposition.
- Strong verbal and written communication, interpersonal and organizational skills.
- Ability to measure and communicate the business value of EHS to all levels within the business.
- Strong project management skills.
- Experience in IVD/Med Device/Life Sciences industry is a plus.
- Effective leadership, presentation, influence, and persuasion skills.
- Experience working in fast paced and dynamic environment with fast global business growth.
- Ability to prioritize and execute work among competing priorities.
- Experience with tactical and strategic safety regulatory leadership and direction as well as working with limited supervision while being responsible for project management, priorities assessment, and global alignment.
Education:
- Minimum of BS Degree, Masters Degree preferred, in Industrial Safety, Occupational Health & Safety, Industrial Hygiene, Environmental Sciences, Environmental Engineering, Safety Engineering, Biology, Chemistry, Chemical Engineering, or Public Health
