QA Manager

Cosmetic Solutions•Boca Raton, FL

15h

About The Position

The Quality Assurance Manager will lead and manage the day-to-day operations of the QA department, ensuring compliance with GMP and other regulatory standards. This role involves overseeing manufacturing and quality activities for cosmetics and OTC drugs, driving continuous process improvement, and promoting safety compliance. The manager will also serve as the primary point of contact for customer QA inquiries, collaborate on quality expectations, and lead customer meetings. Additionally, the position is responsible for developing and conducting training programs, leading and developing the QA team, managing the Quality Management System (QMS), and conducting root cause investigations for quality issues and customer complaints.

Requirements

Bachelor’s degree in technology, Natural Sciences or related field.
Minimum of 5-7 years of experience in Quality Assurance, with at least 2 years in a managerial role in a regulated industry.
Proven experience in dealing directly with QA customers (internal and external), addressing quality issues, and managing customer relationships.
Excellent leadership, communication, and interpersonal skills.
Excellent written and verbal skills, with the ability to explain complex concepts clearly.
Strong organizational and time management skills with the ability to manage multiple projects simultaneously.
Strong problem-solving abilities and the capacity to manage multiple priorities effectively.
Proven experience with quality systems, documentation, and compliance audits.
Ability to work under pressure, meet deadlines, and maintain high attention to detail.

Nice To Haves

Proficiency with learning management systems (LMS) and training development software as needed.

Responsibilities

Lead and manage the day-to-day operations of the QA department to ensure compliance with GMP (Good Manufacturing Practices) and other regulatory standards.
Follow and promote adherence to current Good Manufacturing Practice (cGMP) procedures for the manufacturing of cosmetics and Over the Counter (OTC) drugs under 21CFR211 for all manufacturing and quality activities.
Drive continuous improvement in processes to enhance product quality and efficiency.
Promote a culture where all team members support and follow safety rules and regulations. Ensure that safety protocols are integrated into all aspects of the QA process and that employees are trained to handle potential safety risks related to their tasks.
Manage and provide leadership to direct reports, including the Quality Assurance Supervisor and Document Control Specialist, to ensure effective execution of QA activities and compliance with regulatory standards.
Serve as the primary point of contact for all QA-related inquiries from customers (including pharmaceutical partners), business partners, and third-party vendors.
Collaborate with customers to understand their quality expectations, regulatory requirements, and any specific product needs.
Lead periodic customer meetings to review quality performance, resolve any quality-related issues, and ensure ongoing compliance with customer specifications.
Ensure that customer feedback is effectively integrated into quality processes and communicated across relevant teams.
Develop comprehensive training documentation, including manuals, presentations, e-learning modules, and job aids to support the onboarding and ongoing training of QA team members and other stakeholders.
Deliver both in-person and virtual training sessions on QA methodologies, processes, testing tools, best practices, and industry standards.
Collaborate with QA leadership to identify skills gaps and areas for improvement. Assess the effectiveness of existing training programs and update content accordingly.
Ensure training programs reflect current QA standards, compliance requirements, and best practices. Stay up to date with industry trends and incorporate them into training content.
Provide onboarding training to new QA hires, ensuring they are familiar with testing procedures, tools, and expectations from day one.
Maintain records of all training activities, track participant progress, and provide reports to management on training completion rates, effectiveness, and feedback.
Gather feedback from trainees and stakeholders to assess the effectiveness of training programs, recommend improvements, and implement changes as necessary.
Work closely with other departments (e.g., HR, IT, Development) to ensure training content aligns with overall organizational goals and needs.
Develop metrics to evaluate the effectiveness of QA training programs and use data to continually improve the content and delivery methods.
Lead, mentor, and develop the QA team to foster a culture of quality and compliance.
Develop and implement training programs for new and existing staff, ensuring compliance with company policies, regulatory requirements, and best practices.
Conduct performance evaluations and provide feedback to team members to drive their professional growth.
Ensure that the company’s Quality Management System (QMS) is robust and fully aligned with global regulatory standards.
Coordinate internal audits, risk assessments, and provide guidance to departments on quality initiatives.
Monitor and report on key performance indicators (KPIs) to senior management, ensuring any deviations are addressed promptly.
Support CAPA (Corrective and Preventive Action) systems in response to audit findings or customer complaints, ensuring root cause analysis and appropriate actions are taken.
Lead root cause investigations for quality issues and customer complaints, implementing corrective and preventive actions.
Work cross-functionally with R&D, manufacturing, and supply chain teams to address quality concerns that could affect customer satisfaction or regulatory compliance.