Plan, direct and manage a comprehensive product stewardship strategy to assure compliance with all applicable laws, regulations and management system requirements as they apply to the product lifecycle of the N.A business portfolio. Lead, develop and mentor regulatory professionals within the Product Stewardship function. Establish and manage a process to identify, monitor, analyze and communicate significant business opportunities or risks arising from current and future legislation, industry trends and company-wide objectives. Establish and maintain policies and procedures to assure enterprise-wide training is in compliance with industry product stewardship standards, governing bodies, regulatory and internal requirements.
MAJOR JOB DUTIES AND RESPONSIBILITIES (List in order of importance)
Work with the defined businesses, regulatory agencies, corporate partners and consultants to ensure product-specific regulatory compliance.
Develop and maintain SDSs (Safety Data Sheets), labels and other hazardous communication information for the business portfolio.
Create and maintain product stewardship records relating to company products, intermediates and raw materials for the business portfolio.
Oversee Label Design team and coordinate with site Quality Assurance Managers.
Oversee the application and support of Labeling Software.
Provide technical support regarding the revision or implementation of the documentation of these systems, including procedures, work instructions, and forms.
Conduct assessments and ensure proper implementation of the product safety/product stewardship systems, programs and practices.
Lead product stewardship portion of customer audits, including audit preparation, documentation, follow-up, and closure as it relates to supply chain compliance.
Create and oversee product stewardship information as it relates to N.A. Quality Management Systems.
Provide technical support regarding the revision or implementation of process documentation, including procedures, work instructions, and forms.
Have working knowledge of and support compliance with ISO 9001, ISO 13485, ISO 14001, OHSAS 18001 and FDA Quality System Regulations (QSR).
Evaluate and advise management on current product stewardship regulations and standards, new regulations and/or standards and proposed changes. Provide enterprise-wide strategic insight to senior management.
Provide training as requested. Prepare, conduct, and advise necessary training on product stewardship concepts and tools.
Consult with Sales, Product Development and Quality Assurance on new products to create low hazard product to the extent possible.
Oversee TSCA compliance for the business.
Respond to internal and external requests for product safety information on the business portfolio.
Maintain broad technical expertise as it relates to FDA, TSCA and other global substance control regulations.
Other duties as assigned.
QUALIFICATIONS (Education/Training, Experience and Certifications)
Bachelor’s degree in Engineering, Life Sciences or related discipline
8+ years applicable experience
3+ years leadership experience
KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)
Strong interpersonal and people management skills
Knowledge of ISO Management Systems, SDS software generation.
Strong knowledge with SDS software systems and implementation.
Working knowledge of ISO 9001, ISO 13485 and FDA Quality System Regulations (QSR).
Ability interact with all levels of the organization
Functional knowledge of Microsoft Outlook, Word, and Excel, (or equivalent), highly desired. Previous exposure and experience with automated inventory control systems strongly recommended.
Demonstrated knowledge and experience with software systems and integration with the quality system.
Excellent communication skills – verbal and written
Significant project management experience
ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions)
Typically works in an office environment with adequate lighting and ventilation and a normal range of temperature and noise level.
Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.
A frequent volume of work and deadlines impose strain on routine basis.
Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting or carrying objects that typically weigh less than 50 lbs.
Although the associate primarily works in an office environment, while performing the duties of this job, the associate is exposed to a production environment. The associate may work near moving mechanical machinery and/or vehicles and the noise level in the work environment can be loud. While performing the duties of this Job, the employee is occasionally exposed to fumes or airborne particles and toxic or caustic chemicals.
DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.
We are an Equal Employment/Affirmative Action employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state, or local law.
If you need a reasonable accommodation for any part of the employment process, please contact us by email at email@example.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Avantor® is a leading global provider of integrated, tailored solutions for the life sciences and advanced technology industries. Strengthened by the recent acquisition of VWR, the Company is a trusted partner to customers and suppliers from discovery to delivery. With operations in more than 30 countries and a diverse portfolio that includes more than four million products, Avantor enables customer success through innovation, cGMP manufacturing and comprehensive service offerings. Collectively, we set science in motion to create a better world.