Senior Manager of Quality Assurance

About Company

At the heart of what we are, we are a small company that specializes in manufacturing personal care products. While we are much bigger now than what we were 20 years ago or even 5 years ago, our company was built on a belief that being small meant that we had to be faster than our competition, smarter, braver and of course, nicer. We knew that in order to make it, we had to produce products that our customers needed, in time, priced right, and with the highest quality. We knew innovation meant pushing the envelope on design and thinking. Most importantly, we knew that developing relationships meant building a reputation for coming through on promises and standing behind our product. That is who we are today and how we operate every day.

Position Summary

• The Senior Manager of Quality Assurance oversees the Quality Assurance, Validation, Stability, and Plant Hygiene departments, ensuring that all quality standards, hygiene practices, and regulatory requirements are met across the organization. This role involves strategic planning, leadership, and continuous improvement of quality systems and processes. The Senior Manager of Quality Assurance will provide technical expertise, lead cross-functional projects, and act as a liaison with regulatory agencies.

Responsibilities and Essential Duties

• Provide strategic direction and leadership to the Quality Assurance, Validation, Stability, and Plant Hygiene teams.
• Ensure compliance with all regulatory standards, including cGMP, FDA, and other relevant guidelines.
• Oversee the administration and continuous improvement of the electronic Quality Management System (eQMS) and Document Control systems.
• Support internal and external audits, including the preparation and presentation of audit findings and corrective actions.
• Lead the development and implementation of quality training programs for staff at all levels.
• Oversee the execution of Annual Product Reviews (APRs), mock recalls, and change management processes.
• Collaborate with cross-functional teams to ensure validation projects for new products and changes to existing systems are completed successfully.
• Develop and maintain validation master plans, schedules, and protocols, ensuring alignment with FDA regulatory guidelines.
• Support product validations, including IQ/OQ/PQ, and process validations for OTC production.
• Ensure the Quality Assurance team maintains the highest levels of safety and compliance with safety regulations.
• Provide technical guidance and support for troubleshooting complex quality and validation issues.
• Drive continuous improvement initiatives to enhance quality processes and systems.
• Oversee stability assessments of personal care, cosmetic, and OTC products to ensure long-term stability and quality.
• Partner with formulators, Quality, Sales, Project Management, and Operations to address stability issues.
• Ensure regulatory compliance through adherence to SOPs, good record-keeping, and review of stability test data.
• Develop and maintain expertise with ICH and FDA guidelines.
• Oversee plant hygiene programs, including cleaning validation, environmental monitoring, and hygiene audits.
• Collaborate with the Plant Hygiene Specialist to ensure the plant's compliance with hygiene standards and continuous improvement of overall plant hygiene.

Technical Skills Required

• Strong technical skills with certifications such as ASQ CQM/OE, CQE, CRE, or SSGB preferred.
• In-depth knowledge of FDA regulations, cGMP, and Good Documentation Practices (GDP).
• Excellent project management skills to coordinate multiple projects and adhere to tight timelines.
• Ability to communicate effectively at all levels of the organization, both orally and in writing.
• Strong problem-solving, critical thinking, and decision-making skills.
• Proficient in Microsoft Office software (Word, Excel, PowerPoint).

Experience Required

• Bachelor’s degree in chemistry, biology, microbiology, engineering, or a related field (additional years of experience can substitute).
• Minimum of 10 years of experience in a Quality Assurance or Validation environment within the CPG, Pharmaceutical, or FMCG industries.
• At least 5 years of management experience.
• Extensive exper