DescriptionRole:
The Site Quality Manager will serve as the site lead for all quality-related operations, overseeing the implementation, maintenance, and continual improvement of quality systems to ensure all products meet the highest safety, efficacy, and compliance standards. This role will be responsible for the strategic direction and execution of quality operations across the entire site, including Quality Control (QC), Quality Assurance (QA), and compliance functions.
In addition to managing product lifecycle quality activities, the Site Quality Manager will act as the primary quality representative for the site, collaborating with site leadership to ensure alignment with corporate objectives, regulatory requirements, and customer expectations.
The Site Quality Manager will work closely with manufacturing, R&D, and cross-functional teams to drive quality initiatives, investigate and resolve quality issues, and foster a culture of continuous improvement. Reporting to the VP of Regulatory and Quality, this position ensures that products consistently meet or exceed customer expectations and applicable quality standards.
Responsibilities:
- Manage the daily operations of the Quality Department, including QC and QA functions.
- Maintain and improve the company's Quality Management System (QMS) in accordance with applicable regulations and industry best practices.
- Serve as the site quality lead, representing the Quality function in cross-functional leadership meetings and strategic planning sessions.
- Ensure compliance with U.S. FDA (OTC and cosmetic regulations), EU Cosmetics Regulation, and other applicable quality standards.
- Oversee site-wide compliance with internal policies, regulatory requirements, and industry standards.
- Ensure site readiness for regulatory inspections, client audits, and internal assessments.
- Lead site-level risk management activities related to product quality, including risk assessments and mitigation planning.
- Collaborate with Facilities, Engineering, and EHS to ensure environmental and operational conditions support product quality and regulatory compliance.
- Drive site-wide quality culture initiatives, promoting ownership of quality across all departments.
- Monitor and report on site-level quality KPIs, trends, and performance metrics to senior leadership.
- Support site expansion or transfer projects, ensuring quality systems are appropriately scaled and integrated.
- Train and mentor staff on quality processes, GMP requirements, and continuous improvement practices.
- Monitor quality metrics and prepare reports for leadership to track trends and identify improvement opportunities.
- Support complaint investigations and manage product returns in accordance with established procedures.
- Champion initiatives to enhance product consistency, reduce defects, and improve manufacturing efficiency.
- Other duties as assigned.
Qualifications:
- Bachelor's degree in Quality Management, Life Sciences, Engineering, or a related field.
- 5+ years of quality assurance/quality control experience in cosmetics, OTC, skincare, or related industries.
- Strong understanding of GMP, FDA, and international quality standards.
- Experience managing a QMS and leading audits.
- Demonstrated ability to lead CAPA processes and root cause investigations.
- Strong organizational skills with attention to detail and accuracy.
- Excellent communication skills for cross-functional collaboration
- ASQ (CQE, CQA) certification or equivalent is a plus.
- Experience with site commissioning, validation, or expansion projects is a plus.
Benefits: Life, Dental, Vision, Health, 401k, PTO
