Shire Product Stewardship Lead in Lexington, Massachusetts
The candidate will develop, implement and maintain the procedures and processes for product environmental regulatory requirements such as REACh, RoHS, Packaging and Batteries Directives, Safety Data Sheets (SDSs) and other chemical regulations.
95%: Product Regulatory Compliance
The candidate will:
• Develop procedures and processes for product regulatory compliance efforts
• Coordinate implementation of processes with in the EHS group as well as coordinate with other functional groups on integrating the business requirements
• Support regulatory compliance programs such as GHS for safety data sheets for APIs, Bulk Drug Substances and Final Drug Products (FDP). Other programs include but not limited to REACh, TSCA, California Prop 65, Conflict Minerals etc
• Track of global product regulations along with developing applicability analysis based on the country specific requirements for our raw materials, intermediates and products focusing on US and Asia Developing communication tools to provide to cross functional teams and support implementation of such requirements
• Support development/implementation of automated systems/processes for regulatory tracking, evaluating sales and compliance data for applicable reporting globally. Activities will include development and review of restricted, prohibited substances within raw materials and products which can be provided to R&D and PDTS groups as products are being developed through the stage gate process
• Support implementation of the packaging and batteries requirements and database
• Support the Product Stewardship-EHS team in completing New Product reviews and Management of Change (MoC) requests
• Lead meetings with key stakeholders and cross-functional groups within R&D, Engineering, Procurement, Supply Chain, PDTS and other functions as needed to ensure cross-functional implementation of processes throughout the product development cycle
• Provide high level Product Stewardship and compliance support in Europe, as needed, to provide necessary information to meet compliance
• Support the development and update of Microsoft Share Point site or similar platforms in implementing training, communication tools, procedures and processes to communicate with cross functional groups and internal EHS group. Support the group’s KPIs and metrics related to product stewardship along with providing progress on projects and tasks
• Develop regulatory content for presentations, webinars and other forums for communication as applicable
• Communicate with the Global Product Stewardship Lead and other team members on any roadblocks and issues in meeting timelines, regulatory compliance obligations etc
5%: General EHS Responsibilities
• Mentor Product Stewardship Specialist
• Responsibilities may involve assisting the EHS group with the development and deployment of EHS requirements or program initiatives, contributing to EHS functional teams, participating on EHS facility audits / focused program assessments, and other duties as assigned
Education & Experience Requirements:
• A BS degree in Environmental Studies/Management or in a technical degree such as chemistry, engineering, etc. is required
• At least 5 years of experience in leading compliance programs for RoHS, WEEE, Packaging, REACH, GHS and Conflict Minerals or other product environmental regulations
• The candidate will have minimum 5 years of relevant industry, corporate or consulting experience in this field
• An MS degree in a related field is a plus
• Knowledge of EHS compliance regulations such as waste, wastewater, DOT, IATA and other HazMat regulations
• Experience with ISO 14001/OSHAS 18001 management systems
• Must be able to lift, push, pull and carry up to 50 lbs.
• In general, the position requires a combination of sedentary work and walking around observing conditions in the facility
• When at a manufacturing or R&D facility, must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body
• No make-up, jewelry, nail polish or artificial fingernails may be worn in GMP work environments
• May work in a cold, hot, high-noise, or wet environments.
• Flexibility to engage in work activities outside of the normal 8-hour workday
• Ability to operate a car and travel via air, rail or other means of passenger conveyance. Initially travel for this position will be 10-15% with the potential for multi-week trips
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.