Responsibilities:
- 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 organizations 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 companys 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.
- Bonus
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Remote Work :
No