- Develop, implement, and manage quality assurance policies and procedures, ensuring compliance with international standards and regulatory requirements.
- Lead and manage the quality and regulatory team, fostering a culture of high performance, continuous improvement, and collaborative teamwork.
- Oversee the entire quality assurance process, including audits, inspections, and testing to ensure product integrity and quality.
- Serve as the primary point of contact for all quality-related inquiries and issues, including liaising with external regulatory bodies and auditors.
- Utilize expertise in regulatory compliance to successfully register products, ensuring compliance with FTC/FDA rules and regulations.
- Collaborate with cross-functional teams to address quality issues, implement corrective actions, and ensure that quality objectives are achieved.
- Conduct regular reviews and updates of QA policies and procedures to adapt to new regulations and industry best practices.
- Provide regulatory feedback to R&D regarding proposed product ingredient lists and collaborate with Marketing and Creative teams to ensure global compliance.
- Manage and maintain the Quality Management System (QMS), ensuring documentation is up to date and in compliance with regulatory standards.
- Demonstrated ability to understand, explain, and apply FDA consumer product regulations, with knowledge of FTC regulations being a plus.
- Excellent written, verbal, and interpersonal communication skills, with the ability to prioritize multiple responsibilities and manage deadlines accordingly.
- Proactive nature with a strong desire to learn and develop in the role, coupled with acute attention to detail and high level of organization and accuracy.
- Ability to work autonomously and across teams, developing and maintaining professional and courteous working relationships with global partners.
- Bachelor's degree in a relevant field such as Quality Management, Engineering, Science, Chemistry, Biology, Life Sciences, Legal, or Regulatory Affairs.
- A minimum of 5 years of experience managing a quality and regulatory team within a regulated industry, with at least 3 years regulatory/compliance experience in the personal care product industry.
- Demonstrated expertise in Quality Management Systems (QMS) and thorough understanding of regulatory standards such as ISO 9001, FDA, EMA, etc.
- Hands-on experience with international product registration and labeling requirements.
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Quality Assurance Manager - Saint Paul, United States - Bell International Laboratories
Description
Position Overview: We are seeking an experienced Quality Assurance and Regulatory Compliance Manager to lead our quality and regulatory team in the personal care industry. This role combines a strong foundation in quality assurance with a deep expertise in regulatory compliance, including organizing and facilitating regulatory matters with government and beauty industry authorities. This role demands a professional with a strategic mindset for continuous improvement, a commitment to excellence, and the ability to manage multiple projects with high accuracy and attention to detail.
Key Responsibilities:
Required Skills/Abilities:
Required Education and Experience:
Preferred Qualifications:
Master Degree is a plus
Notary public qualification/license advantageous.
Foreign language skills and experience with related databases are a plus.