Position Overview The Director Quality Systems is responsible for developing, implementing, and maintaining individual sub-systems of the Pharmaceutical Quality Systems (PQS) for FDBT. Responsibilities will include one or more PQS sub-systems: Deviation, CAPA, Change Control, Supplier Quality, Training, Document Control, QA Validation, e QMS, and Quality Management. Lead the assigned team to create a strong quality culture of engaged and motivated staff maintaining strong working relationships with internal and external stakeholders. Ensure the site PQS sub-system is aligned with the harmonized global FDB PQS, organizational goals and objectives, and areas of continuous improvement. Job Description Essential Functions: Develop, implement, and maintain the risk-based PQS sub-systems to meet all CGMP regulatory requirements for phase-appropriate clinical and commercial bulk drug substance and drug product manufacture. Establish governance and oversight processes to ensure the organization is continuously complying with site and global quality standards, regulatory requirements, and partner commitments. Lead the Quality Systems team to deliver exceptional performance of each assigned sub-system. Deviation, CAPA, Change Control Supplier Quality Training Document Control, e QMSQA Validation Quality management Liaise with internal and external stakeholders to achieve expected business outcomes. Partner with Quality Compliance to ensure the site is inspection ready at all times. Implement audit/inspection learnings within the site QMS; share learnings between FDB sites. Identify areas of risk and/or continuous improvement; escalate/communicate as appropriate. Provide expert guidance and interpretation on regulatory requirements. Recruit, hire, and manage the team in line with FDBT policies and practices. Ability to serve as deputy for Senior Director Quality Systems. Any other duties as assigned. Required Skills & Abilities: Expert understanding of Pharmaceutical Quality Systems. Excellent written and oral communication skills. Excellent organizational, analytical, data review and report writing skills. Ability to set personal performance goals and provide input to departmental objectives. Develop staff to maximize contributions to the team and the company. Ability to multitask and easily prioritize work. Ability to work independently with little supervision. Proficient in Microsoft Excel, Word and Power Point. All candidates must have a working knowledge of CGMP regulations for the production of drug substance, drug product, biologics, vaccine, and/or advanced therapy products. Qualifications: Bachelor’s degree with 10 years of relevant experience in a regulated pharmaceutical, biotechnology, or supporting a CDMO environment; ORAssociate’s degree with 12 years of relevant experience in a regulated pharmaceutical, biotechnology, or supporting a CDMO environment. At least 6 years of experience in a supervisory or managerial role. A minimum of 5 years of experience working with biologics (vaccines, gene therapy, m Ab, etc.) in a QA or QC role. Preferred Qualifications: Experience with biologics – vaccines, gene therapy, m Ab, etc. Experience within CDMOAdvanced Degree ASQ Certification Join us! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large.
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