Signature Biologics is a biopharmaceutical company developing novel cellular and biologics therapeutics for unmet clinical needs. We have significant clinical experience working with human perinatal biologics internationally and we are currently developing the products in US.

The Director of Quality Systems is responsible for determining and leading the QA strategy for the company and will lead the effort to develop, implement and manage appropriate quality systems and controls as the company progresses from preclinical and early clinical studies to later stages of clinical development and commercialization. Top candidates are strategic thinkers with excellent communication skills; motivated to inspire and lead others to achieve the critical mission of the Quality function.

Specifically, the Director will develop and oversee quality aspects of pharmaceutical development for drug substance, drug product, and clinical trial material including the quality aspects of process and formulation development, manufacturing, analytical testing, packaging, product release, and associated stability programs for assigned drug programs. They will also oversee Good Clinical Practice compliance. The individual in this role must be a catalyst for continuous process improvement and manage the initiatives to implementation.

Responsibilities:

• Develop quality policies, annual goals, and objectives in alignment with company goals and objectives.
• Establish and maintain risk-based and fit-for-purpose quality management system (QMS) ensuring effective implementation, which is managed and continuously improved to sustain compliance with internationally recognized standards.
• Establish and manage departmental goals compatible with corporate objectives and program milestones.
• Provide expertise for Manufacturing, Development, Clinical and other internal departments to develop processes/procedures related to quality assurance activities for GXP (GTP, GMP, GLP and GCP) compliance and ensure compliance in all areas.
• Develop processes and procedures for the selection and management of third-party service providers (e.g., contract manufacturers, testing laboratories) to ensure expectations for quality and compliance are documented and met.
• Develop, implement and maintain quality systems for lot release, training and tracking discrepancies, investigations, audits, change control, etc.
• Manage the controlled document system; review and approve operating procedures for GXP operations.
• Direct the supplier quality program to ensure R&D, manufacturing, and service providers are classified for risk. Conduct supplier audits and assessments. Establish quality agreements with critical suppliers.
• Host regulatory inspections and coordinate responses to findings.

Requirements:

• 10 years of pharmaceutical or biotechnology experience and broad range of knowledge in quality assurance, quality control, and regulatory, preferably with cell based-therapeutics.
• BA/BS/Ph. D in life sciences or related field. Advanced degree desirable, but not required.
• Experience implementing quality assurance systems in a GMP environment, and direct experience with vendor audits and inspections.
• Extensive knowledge of GXP compliance regulations and industry.
• Strong leadership and management. Demonstrated ability to successfully lead team and develop employees.
• Excellent communication skills (verbal, written, and presentation) that facilitate strategy deployment to all levels of the organization.
• Demonstrated ability to partner/collaborate with other functional group to achieve business objectives.

Location:

On-site, Irving TX.