Director, Quality Systems and Compliance

Job title:

Director, Quality Systems and Compliance

Company

Pierre Fabre

Job description

Your missionDirector, Quality Systems and CompliancePierre 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:We are seeking an experienced, highly motivated, and well-organized Quality professional to join our fast-paced, growing Cell Therapy company. This position is responsible for leading Quality Systems and Compliance for Pierre Fabre Pharmaceuticals US – Cell Therapy. Ensuring the highest standards of quality and compliance across all aspects of our operations. Reporting directly Head of Quality, you will lead the development, implementation, and maintenance of quality systems and processes to meet regulatory requirements and industry best practices.ESSENTIAL FUNCTIONS:

• Strategic Leadership: Develop and execute strategies to establish and maintain a robust quality management system (QMS) that aligns with global regulatory requirements and industry standards.
• Regulatory Compliance: Serve as a point of contact for regulatory agencies and ensure compliance with applicable regulations, including but not limited to FDA, EMA, and other international regulatory authorities.
• Quality Systems Development: Lead the design, implementation, and continuous improvement of quality systems, including document control, training, deviation management, change control, and CAPA processes.
• Document Control: Experience in developing and managing document control processes, including document creation, review, approval, distribution, and archival, to ensure compliance with regulatory requirements and internal quality standards. Familiarity with electronic document management systems is required.
• Deviation Management: Demonstrated expertise in implementing deviation management systems to investigate, document, and resolve deviations from established procedures and specifications. Ability to lead root cause analysis investigations and implement corrective and preventive actions (CAPAs) to prevent recurrence.
• Supplier Quality Management: Knowledge of supplier quality management processes, including supplier selection, qualification, and ongoing monitoring. Experience in conducting supplier audits and managing supplier corrective actions to ensure the quality and reliability of raw materials and components.
• Quality Metrics and Reporting: Proficiency in defining and monitoring key quality metrics to assess the performance of quality systems and identify opportunities for improvement. Ability to prepare comprehensive quality reports and presentations for management review and regulatory submissions.
• Audits and Inspections: Prepare the organization for regulatory inspections and internal/external audits, ensuring readiness and compliance with regulatory requirements. Lead responses to audit findings and observations.
• Risk Management: Implement risk-based approaches to identify, assess, and mitigate quality and compliance risks throughout the product lifecycle.
• Training and Development: Develop and deliver comprehensive training programs on quality systems, regulatory requirements, and compliance expectations to ensure staff competency and adherence to quality standards.
• Cross-Functional Collaboration: Collaborate closely with other departments, including Manufacturing, Research and Development, Clinical Operations, and Regulatory Affairs, to ensure quality and compliance considerations are integrated into business processes.
• Continuous Improvement: Drive a culture of continuous improvement by monitoring key quality metrics, analyzing trends, and implementing initiatives to enhance quality performance and efficiency.
• Quality Culture: Foster a culture of quality and compliance excellence throughout the organization by promoting awareness, accountability, and ownership of quality responsibilities at all levels.

REQUIRED EDUCATION AND EXPERIENCE:

• Bachelor’s degree in a scientific or engineering discipline; advanced degree preferred.
• Bachelor’s degree in applicable field required and 12 years of experience OR Masters and 10 years.
• Minimum of 8-10 years of experience in Quality Assurance/Quality Control roles within the biopharmaceutical industry, with at least 5 years in a leadership position.
• In-depth knowledge of cGMP regulations, ICH guidelines, and other relevant regulatory requirements for cell therapy products.
• Proven track record of successfully leading quality system implementation and compliance efforts, including interactions with regulatory agencies and successful regulatory inspections.
• Strong leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively across functions and levels of the organization.
• Strategic thinker with the ability to develop and execute on complex quality and compliance strategies.
• Demonstrated ability to drive change, foster innovation, and build a culture of continuous improvement.
• Location: Remote with routine travel to NJ office and occasional travel to other company sites and external meetings as needed.

WORK ENVIRONMENT:

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

Benefits of being a Pierre Fabre EmployeeJoin 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 FabrePierre 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.Who you are ?We are convinced that diversity is a source of fulfillment, social balance and complementarity for our employees, which is why our offers are open to all, without restriction.

Expected salary

Location

USA

Job date

Sat, 29 Jun 2024 07:16:35 GMT

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