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Product Integrity Scientist

Swiss American CDMO
Carrollton, TX

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Job Details

Qualifications

Optimizing workflow processes
Customer communication
Staff supervision
Safety regulations
Drug regulation
Collaboration with product development teams
Bachelor's degree
Leading team collaboration initiatives
Biomedical regulatory compliance
Managing projects
Productivity software
Process improvement planning
Cross-functional team management
Research & development
Cross-functional communication

Full Job Description

Position Summary: The Product Integrity Scientist will support product safety/integrity related to regulatory affairs for product development, raw materials or finished products. They will provide product integrity support for Swiss American Contract Development and Manufacturing (SA). The person in this role will support sound product safety strategy and follow-through implementation for product, finished good and product compliance in different skin health categories across global regions. As the product integrity personnel in the organization, this role is responsible for supporting product safety and compliance.

Essential Duties and Responsibilities:

Responsible for managing product safety and compliance intelligence, policies, and programs of diverse scope across the business for raw materials, bulk products, finished and commercialized goods
Responsible for creation of cosmetic ingredient declaration, quantitative and qualitative formulas
Review and assess changes to safety and global regulatory requirements and industry best practices and facilitate implementation through new or revised processes.
Responsible for evaluating and assessing safety and regulatory compliance of raw materials used at SA
Responsible for safety and regulatory documentation for compliance requested by clients on SA formulations
Responsible for safety assessments and compliance evaluations for skincare, OTC and medical device products across global regions including but not limited to prop 65, impurities, EU allergens etc.
Responsible for working with other employees to ensure adherence to compliance of products, resolve compliance issues, as appropriate, and communicate as required to clients.
Develop, plan, oversee and generate clinical, in vitro, in silico studies, and/or technical reviews which will insure the efficacy and safety of Swiss American products or Swiss American contracted formulations
Expertise in methodologies used to assess the safety and efficacy of OTC, cosmetic and medical devices
Manage client meetings and responses for ingredient and regulatory compliance
Responsible for owning and maintaining current formulation system (Formulator Pro) to manage ingredient entry, ingredient compliance etc.
Oversee the creation and/or maintenance of technical files as necessary to obtain and sustain product approval.
Determine and communicate submission and approval requirements early in the product lifecycle to assure that projects plans are aligned to meet safety and regulatory guidelines.
Participate in multidisciplinary project teams with the Client.
Responsible for RID product safety compliance metrics for Quality Management Reviews.
Responsible for SA quarterly newsletter on compliance based on research and interpretation of compliance guidelines
Other duties may be assigned.

Essential Skills and Qualifications:

Experienced in leading cross-functional interactions related to product safety matters
Bachelor's Degree in Life Sciences or related field.
Preferred: Advanced Degree (e.g., Master's, PhD) in a relevant field.
Minimum 4+ years of relevant experience in the skincare, pharmaceutical, or OTC industry.
Minimum 3 years of experience in a Product Safety/Regulatory function.
Proven experience in skincare OTC and medical device product safety and compliance, with a history in clinical studies preferred.
Experience interacting with regulatory agencies (e.g., FDA, EMA, Health Canada).
Strong understanding of pharmaceutical and medical device R&D, product development, and regulatory environments.
In-depth knowledge of global product safety and regulatory requirements for skincare, OTC, and medical devices.
Proven ability to lead cross-functional teams and manage complex projects.
Excellent analytical, problem-solving, and decision-making skills.
Strong written and verbal communication and interpersonal skills.
Proficiency in Microsoft Office Suite.
Experience with process management and continuous improvement.
Demonstrated knowledge of global regulations and compliance requirements.
Ability to analyze complex situations, identify risks, and develop effective strategies.
Ability to lead teams, build relationships, and effectively collaborate with cross-functional partners.
Proven ability to manage multiple projects with aggressive timelines and deliver high-quality results.
A proactive approach to identifying and implementing process improvements.
May be responsible for supervising a team of 3-6 personnel.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment Is usually moderate.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.

Candidates selected for employment will be required to complete a pre-employment screening, including a drug test, employment verification, and education verification.

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