Site Product Compliance Leader

Job description

3184866
Additional Cities

Logan
Career Level

Experienced
Relocation Assistance

No
Business

GE Healthcare
Business Segment

Healthcare Global Supply Chain
Function

Engineering/Technology
Country/Territory

United States
Additional States/Provinces

Utah
Postal Code

84321
Role Summary/Purpose

The Site Product Compliance Leader is responsible for the management and implementation of activities linked to requirements set by global chemical and environmental product compliance regulations. The primary responsibility is to coordinate and execute all activities relevant to global chemical and environmental regulations affecting products manufactured on the Logan site and their placement on the global market.
Essential Responsibilities

The role includes the management of registration(s), authorization(s), applications, amendments, related to product regulatory compliance and specific to the site and products manufactured on the site. The Site Product Compliance Leader is accountable for raising site needs, concerns and requirements related to product regulatory compliance, coordinating efforts to meet these requirements and implementing site specific processes to sustain product regulatory compliance. The Site Product Compliance Leader works closely with the GE Healthcare Life Sciences Product Governance and Compliance Department, especially with the Product and Technology Compliance team, using a pitcher-catcher model. The Site Product Compliance Leader is also the site main point of contact for compliance projects. This leader will provide practical support on global compliance strategies and detailed compliance expertise to address them at the Logan site.

• Coordinate and execute with cross-functional site teams all activities and projects relevant to global chemical and environmental regulations affecting products manufactured on the Logan site and their placement on the global market. 
• Ensure site’s product regulatory compliance requirements remain up to date on new and legacy products by working with the GE Healthcare Life Sciences Product Governance and Compliance Department, especially the Product and Technology Compliance team. 
• Stay abreast of rapidly emerging technologies for manufacturing and new products to ensure proactive and ahead-of-the-curve compliance measures are in place in advance of deployment. 
• Track all product regulatory compliance metrics relevant to the site and products manufactured on the site. 
• Support global compliance projects driven by the GE Healthcare Life Sciences Product Governance and Compliance organization and related to GE Healthcare Life Sciences legacy products. 
• Manage and maintain registration(s), authorization(s), applications, amendments, related to product regulatory compliance and specific to the Logan site and products manufactured on the Logan site. 
• Ensure that special requirements, registrations/authorizations by hazard class compliance definitions specific to use, intent, purpose or market are fulfilled. 
• Develop, implement and document site specific tools and processes for products manufactured by the site, where and being shipped through and to, by distribution warehouse(s), direct shipments, and country(s)/region(s) by product/chemicals and amounts. 
• Ensure requirements regarding Safety Data Sheets (SDSs) and hazardous labeling for products manufactured on the Logan site are followed to meet global compliance, such as Global Harmonized System (GHS) and country/regional specific requirements. 
• Track global product regulatory compliance requirements through external tools such as 3E Insight. 
• Audit and review site specific processes implemented for adherence to global product regulatory compliance requirements. 
• Provide education, guidance, and coaching to site cross-functional teams including engineering, manufacturing, sourcing, and product management, to achieve product regulatory compliance for legacy products and New Product Introduction projects. 
• Monitor adherence to processes and guidelines developed by the GE Healthcare Life Sciences Product Governance and Compliance team, such as product regulatory compliance processes and guidelines in New Product Introduction processes. 
• Work closely with the site EHS team accountable for the chemical management of chemical raw materials purchased and introduced on the site.

Qualifications/Requirements

REQUIREMENTS: 
• Bachelor’s degree and 1-2 years relevant experience or a minimum of 3-5 years of experience in Product Compliance related field. 
• Understand current and new product regulatory compliance requirements 

RECOMMENDED: 
• Higher education in chemistry, industrial hygiene, environmental science, chemical/environmental engineering or related field.
• Experience from relevant chemical industry, such as life sciences industry. 
• Knowledge of and experience in working with national and local environmental and chemical regulations, and related compliance strategies. 
• Experience in working cross-functionally with global teams across diverse geographic areas and regulatory regimes. 
• Compliance audit skills. 
• Experience conducting internal trainings.
• Experience managing cross-functional and multi-disciplinary projects. 
• Proficient in computer software needed to perform duties (e.g., Word, Excel, etc.). 
• Proficient in use of systems such BioProd, Magic, CHEMMATE, and Master Control. 
• Understand current and new product regulatory compliance requirements as shared by the GE Healthcare Life Sciences Product and Technology Compliance team.

Desired Characteristics

• Experience working in a matrix organization, ability to work effectively in multiple countries. 
• Strong project management skills and the ability to set priorities to ensure on time delivery for multiple projects. 
• Ability to keep abreast of product regulatory compliance changes. 
• Proven ability to execute and deliver on commitments.
• Excellent analytical and communication skills. 
• Ability to accurately record and evaluate detailed information. 
• Demonstrated self-starter and team player. 
• Self-motivated, responsible and comfortable independently making decisions. 
• Creative problem-solving skills. 
• Excellent communicator (written and verbal communication skills). 
• Good networking capabilities. 
• Fluent in English, and capable of leading/participating in conference calls in English.

About Us

GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers. www.ge.com

There is no other life sciences company quite like GE Healthcare Life Sciences. A $5 billion business with more than 11,000 individuals in over 100 countries, we are at work enabling a new era in medicine. For more than 60 years, GE Healthcare Life Sciences has globally supported the development and use of new therapies, helping accelerate the journey from biological understanding to clinical therapy. GE Healthcare Life Sciences works with cutting edge technology enabling and advancing the discovery, diagnosis and medical treatments of the present and the future. We are accelerating biology to cell therapy in ways no other company can. Follow us on Facebook and Twitter and watch our discoveries in action on our YouTube channel. Learn More About GE Healthcare – Life Sciences

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is anEqual Opportunity Employer . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Additional Eligibility Qualifications

GE will only employ those who are legally authorized to work in the United States for this opening.
Primary Country

United States
Primary State/Province

Utah
Primary City

Logan