Quality Sr. Manager

Quality and Compliance Manager 

Pierre Fabre, the second-largest private French pharmaceutical group and the world's second-largest dermo-cosmetics lab offers you a dynamic, purpose-driven career.  

Primarily owned by The Pierre Fabre Foundation, a government-recognized public-interest foundation, we take pride in our expertise in oncology.  

Beyond being employees, we act as entrepreneurs, and our work is a pursuit of purpose and performance. Join us in our mission to protect and preserve the health and sustainability of all people and our planet. Innovate, collaborate with healthcare professionals, and make a difference with "New Ways to Care."  

Join Pierre Fabre Pharmaceuticals to make a real impact in people's lives. Your purposeful career begins here. 

SUMMARY: 

The Quality Sr. Manager is responsible for managing and overseeing quality systems and compliance activities within the organization. This role ensures adherence to regulatory standards and internal quality policies, particularly focusing on Corrective and Preventive Actions (CAPA), deviations, and change control processes. The Quality Sr. Manager will work closely with cross-functional teams to drive continuous improvement and ensure product quality and compliance. 

RESPONSIBILITIES: 

• Quality Systems Management
  • Develop, implement, and maintain quality management systems in compliance with regulatory requirements (e.g., ISO, FDA, GMP).
  • Monitor and improve the effectiveness of quality systems and procedures.
  • Ensure proper documentation and record-keeping for all quality-related activities.
• CAPA Management
  • Oversee the CAPA process, including investigation, root cause analysis, and implementation of corrective and preventive actions.
  • Track and report CAPA metrics to senior management.
  • Ensure timely closure of CAPAs and verification of effectiveness.
• Deviation Management
  • Manage the deviation process, including identification, documentation, investigation, and resolution of deviations.
  • Collaborate with relevant departments to analyze deviations and implement corrective actions.
  • Maintain deviation logs and ensure compliance with regulatory requirements.
• Change Control
  • Administer the change control process to ensure all changes are assessed, approved, and implemented correctly.
  • Coordinate with cross-functional teams to evaluate the impact of changes on product quality and regulatory compliance.
  • Maintain records of all change control activities and ensure timely review and approval.
• Compliance and Audits
  • Ensure compliance with all applicable regulatory standards and internal policies.
  • Prepare for and participate in internal and external audits and inspections.
  • Address audit findings and implement necessary corrective actions.
• Continuous Improvement
  • Identify opportunities for process improvement and implement best practices in quality management.
  • Lead and participate in quality improvement projects and initiatives.

REQUIRED EDUCATION AND EXPERIENCE: 

• Bachelor’s degree in a related field (e.g., Quality Management, Engineering, Life Sciences).
• Minimum of 8-10 years of experience in quality management within a regulated industry.
• Strong knowledge of quality management systems, CAPA, deviation management, and change control.
• Strong knowledge with regulatory standards (e.g., ISO, FDA, GMP, EMA).
• Excellent analytical, problem-solving, and decision-making skills.
• Strong communication and interpersonal skills.
• Proficiency in quality management software and tools.
• Certification in Quality Management (e.g., ASQ, Six Sigma) is a plus.

LOCATION:  

Secaucus, NJ.  

Remote option will be considered with some travel (10-15%) to NJ office as needed 

WORK ENVIRONMENT: 

Reasonable accomodations may be made to enable individuals with disabilities to perform the essential functions. 

Benefits of being a Pierre Fabre Employee 

Join Pierre Fabre for competitive benefits including three medical plans, dental and vision coverage, voluntary benefits, a 401(k) plan, and more! Our offerings also include a hybrid work policy, a generous PTO policy and company holidays, paid parental leave, discounts on our products, learning and development opportunities, and access to mental health and wellness programs, creating a well-rounded work experience for our employees. 

Pierre Fabre  

Pierre Fabre has been recognized by Forbes as one of the "World's Best Employers" for the 3rd year running.  

https://www.pierre-fabre.com/en-usTrue to My Nature 

Pierre Fabre is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.