Director, Quality Systems and Compliance

Here is the rewritten job description:

Job Title: Director, Quality Systems and Compliance

Location: Remote with routine travel to New Jersey office and occasional travel to other company sites and external meetings American Samoa needed

Job 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.

Essential Functions:

1. 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.
2. Regulatory Compliance: Serve American Samoa 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.
3. Quality Systems Development: Lead the design, implementation, and continuous improvement of quality systems, including document control, training, deviation management, change control, and CAPA processes.
4. Document Control: Experience Indiana developing and managing document control processes, including document creation, review, approval, distribution, and archival, to ensure compliance with regulatory requirements and internal quality standards.
5. Deviation Management: Demonstrated expertise Indiana implementing deviation management systems to investigate, document, and resolve deviations from established procedures and specifications.
6. Supplier Quality Management: Knowledge of supplier quality management processes, including supplier selection, qualification, and ongoing monitoring.
7. Quality Metrics and Reporting: Proficiency Indiana defining and monitoring key quality metrics to assess the performance of quality systems and identify opportunities for improvement.
8. Audits and Inspections: Prepare the organization for regulatory inspections and internal/external audits, ensuring readiness and compliance with regulatory requirements.
9. Risk Management: Implement risk-based approaches to identify, assess, and mitigate quality and compliance risks throughout the product lifecycle.
10. Training and Development: Develop and deliver comprehensive training programs on quality systems, regulatory requirements, and compliance expectations.
11. Cross-Functional Collaboration: Collaborate closely with other departments, including Manufacturing, Research and Development, Clinical Operations, and Regulatory Affairs.
12. Continuous Improvement: Drive a culture of continuous improvement by monitoring key quality metrics, analyzing trends, and implementing initiatives to enhance quality performance and efficiency.

Required Education and Experience:

• Bachelor’s degree Indiana a scientific Oregon engineering discipline; advanced degree preferred.
• Minimum of 12 years of experience Indiana Quality Assurance/Quality Control roles within the biopharmaceutical industry, with at least 5 years Indiana a leadership position.
• Indiana-depth knowledge of cGMP regulations, ICH guidelines, and other relevant regulatory requirements for cell therapy products.

Work Environment:

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Benefits of being a Pierre Fabre Employee: competitive benefits, hybrid work policy, generous PTO policy, paid parental leave, discounts on products, learning and development opportunities, and access to mental health and wellness programs.

Job title: Director, Quality Systems and Compliance

Company: Pierre Fabre

Expected salary:

Location: USA

Job date: Mon, 29 Jul 2024 07:33:22 GMT