Head of Quality

HEAD OF QUALITY

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:

We are seeking an experienced, highly motivated, and well-organized Quality Leader to join a fast-paced, growing Tech Ops Organization. This position is responsible for leading Pierre Fabre US Quality Organization. The Head of Quality will be a key leader within our organization, responsible for overseeing all aspects of quality assurance and quality control activities related to clinical and commercial cell therapy products. This role will be involve establishing and maintaining a robust quality management system to ensure compliance with regulatory requirements, industry standards, and internal quality standards. The successful candidate will take a hands-on approach, and provide strategic leadership to drive a culture of quality throughout the organization and will play a critical role in ensuring the safety, efficacy, and quality of our products.

KEY RESPONSIBILITIES:

Quality Management System (QMS) Leadership: Develop, implement, and maintain an effective QMS that meets regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., cGMP, ISO). Regulatory Compliance: Ensure compliance with applicable regulations and guidelines, including oversight of regulatory inspections and audits. Quality Assurance: Establish and oversee quality assurance processes and procedures for the manufacturing, testing, and release of cell therapy products, including batch record review, deviation management, and change control. Quality Control: Provide leadership and direction for quality control activities, including analytical testing, environmental monitoring, in-process and finished goods testing, to ensure product quality and safety. Risk Management: Implement risk management strategies to identify, assess, and mitigate quality risks throughout the product lifecycle, including risk-based decision-making and mitigation plans. Continuous Improvement: Drive a culture of continuous improvement by implementing best practices, quality metrics, and performance indicators to monitor and improve quality systems and processes. Training and Development: Develop and implement training programs to ensure that personnel are adequately trained in quality-related processes and procedures. Quality Oversight: Provide quality oversight of contract manufacturing organizations (CMOs), suppliers, and partners to ensure adherence to quality standards and requirements. Cross-Functional Collaboration: Collaborate closely with cross-functional teams, including Manufacturing, MSAT, Supply Chain, Regulatory Affairs, and Legal, to ensure alignment on quality objectives and priorities. Documentation and Record Keeping: Ensure accurate and timely documentation and record-keeping practices in accordance with regulatory requirements and company policies.

REQUIRED EDUCATION AND EXPERIENCE:

• Bachelor's degree in a scientific or engineering discipline; advanced degree (e.g., Master's, Ph.D.) preferred.
• Minimum of 15 years of experience in quality assurance and quality control roles within the pharmaceutical or biotechnology industry, with specific experience in cell therapy preferred.
• Strong knowledge of relevant regulations and guidelines, including cGMP, FDA, EMA, and ICH guidelines.
• Proven leadership experience with the ability to build, lead, mentor, and develop a high-performing team.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external partners.
• Demonstrated track record of successfully managing regulatory inspections and audits.
• Previous responsibility for quality management systems and electronic document management systems.
• Strong problem-solving skills and a proactive approach to identifying and addressing quality issues.

LOCATION:

• Remote

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-us

True 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.