QA Manager
Cosmetic Solutions, Boca Raton, FL, United States
Job Title: QA Manager / Quality Assurance Manager
Reports to: Director of Quality Assurance
Support to: Quality Assurance, Sales
Key Responsibilities
Quality Assurance Oversight:
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 (under the Federal Food, Drug, and Cosmetic Act and the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)) 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.
Support Safety Compliance: 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.
Interface with Customers as Quality Assurance:
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.
Training & Documentation:
Proficiency with learning management systems (LMS) and training development software as needed.
Develop Training Materials: Create 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.
Conduct Training Sessions: Deliver both in-person and virtual training sessions on QA methodologies, processes, testing tools, best practices, and industry standards.
Assess Training Needs: Collaborate with QA leadership to identify skills gaps and areas for improvement. Assess the effectiveness of existing training programs and update content accordingly.
Quality Assurance Best Practices: 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.
Onboarding Support: Provide onboarding training to new QA hires, ensuring they are familiar with testing procedures, tools, and expectations from day one.
Track and Report Progress: Maintain records of all training activities, track participant progress, and provide reports to management on training completion rates, effectiveness, and feedback.
Continuous Improvement: Gather feedback from trainees and stakeholders to assess the effectiveness of training programs, recommend improvements, and implement changes as necessary.
Collaboration: Work closely with other departments (e.g., HR, IT, Development) to ensure training content aligns with overall organizational goals and needs.
Metrics and Evaluation: Develop metrics to evaluate the effectiveness of QA training programs and use data to continually improve the content and delivery methods.
Team Leadership & Development:
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.
Quality Systems Management:
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.
Problem Solving & Root Cause Analysis:
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.
Qualifications & Requirements
Education:
Bachelor’s degree in technology, Natural Sciences or related field.
Experience:
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.
Skills:
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.
Equal Employment Opportunity
Cosmetic Solutions is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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Reports to: Director of Quality Assurance
Support to: Quality Assurance, Sales
Key Responsibilities
Quality Assurance Oversight:
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 (under the Federal Food, Drug, and Cosmetic Act and the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)) 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.
Support Safety Compliance: 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.
Interface with Customers as Quality Assurance:
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.
Training & Documentation:
Proficiency with learning management systems (LMS) and training development software as needed.
Develop Training Materials: Create 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.
Conduct Training Sessions: Deliver both in-person and virtual training sessions on QA methodologies, processes, testing tools, best practices, and industry standards.
Assess Training Needs: Collaborate with QA leadership to identify skills gaps and areas for improvement. Assess the effectiveness of existing training programs and update content accordingly.
Quality Assurance Best Practices: 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.
Onboarding Support: Provide onboarding training to new QA hires, ensuring they are familiar with testing procedures, tools, and expectations from day one.
Track and Report Progress: Maintain records of all training activities, track participant progress, and provide reports to management on training completion rates, effectiveness, and feedback.
Continuous Improvement: Gather feedback from trainees and stakeholders to assess the effectiveness of training programs, recommend improvements, and implement changes as necessary.
Collaboration: Work closely with other departments (e.g., HR, IT, Development) to ensure training content aligns with overall organizational goals and needs.
Metrics and Evaluation: Develop metrics to evaluate the effectiveness of QA training programs and use data to continually improve the content and delivery methods.
Team Leadership & Development:
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.
Quality Systems Management:
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.
Problem Solving & Root Cause Analysis:
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.
Qualifications & Requirements
Education:
Bachelor’s degree in technology, Natural Sciences or related field.
Experience:
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.
Skills:
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.
Equal Employment Opportunity
Cosmetic Solutions is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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