Develop and implement a comprehensive quality management system (QMS) that integrates all aspects of quality assurance, quality control, and compliance processes across the organization.
Ensure compliance with national and international regulations and standards related to personal care products, including FDA, EPA, ISO, and other applicable industry standards.
Lead the Quality and Compliance department, setting objectives, budgeting, and staffing to effectively support the organization's goals and growth.
Establish and maintain a strong culture of quality and continuous improvement, including the adoption of best practices and innovative quality assurance technologies.
Oversee the management of audits, both internal and external, ensuring compliance with regulatory standards and identifying opportunities for process improvement.
Work closely with R&D, production, and supply chain teams to integrate quality and compliance considerations into product development and manufacturing processes.
Manage relationships with regulatory bodies and industry associations, staying ahead of changes in legislation and standards that could impact the company's products or processes.
Lead the response to quality or compliance issues, including product recalls, regulatory actions, and customer complaints, ensuring timely and transparent communication with all stakeholders.
Provide strategic leadership and guidance on quality and compliance matters to the executive team, contributing to the overall strategic direction of the company.
Qualifications:
Bachelors degree in a related field (e.g., Chemistry, Biology, Engineering); Masters degree or higher preferred.
Minimum of 10 years of experience in quality assurance/compliance roles within the personal care, pharmaceutical, or related manufacturing industries, with at least 5 years in a senior leadership position.
Comprehensive knowledge of regulatory requirements and industry standards applicable to personal care products.
Proven track record of implementing and managing a QMS in a manufacturing environment.
Experience in submission of at least one of the following: 510k / PMN medical device, IND, NDA, or ANDA.
Preferred Qualifications:
Strong leadership and organizational skills, with the ability to inspire and lead teams towards excellence.
Excellent communication and interpersonal skills, with the ability to interact effectively with all levels of the organization and external partners.
Strategic thinker with the ability to balance regulatory compliance with business objectives.
Acute attention to detail and high level of organization and accuracy.
Proficiency with Microsoft Office.
Seniority level
Executive
Employment type
Full-time
Job function
Quality Assurance
Industries
Staffing and Recruiting
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