Quality Management Director

14 hours ago

Parsippany, New Jersey, United States Pierre Fabre Full time
Quality Sr. Manager

Pierre Fabre, a leading pharmaceutical company, is seeking a Quality Sr. Manager to oversee quality systems and compliance activities within the organization. This role ensures adherence to regulatory standards and internal quality policies, focusing on Corrective and Preventive Actions (CAPA), deviations, and change control processes.

Key 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.
Requirements:
  • 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 accommodations may be made to enable individuals with disabilities to perform the essential functions.

Benefits:

Pierre Fabre offers 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.

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

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.

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