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Director of Compliance and Quality Assurance
2 weeks ago
The Director Quality Systems will be responsible for developing, implementing, and maintaining individual sub-systems of the Pharmaceutical Quality Systems (PQS) for FDBT. This includes leading a team to create a strong quality culture of engaged and motivated staff maintaining strong working relationships with internal and external stakeholders.
Main Responsibilities
- Develop, implement, and maintain 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 Compliance team to deliver exceptional performance of each assigned sub-system, including Internal Audit, External (Customer) Audit, Health Authority Inspection & Remediation.
- Liaise with internal and external stakeholders to achieve expected business outcomes, and provide expert guidance and interpretation on regulatory requirements.
- Recruit, hire, and manage the team in line with FDBT policies and practices.
Requirements
- Expert understanding of Pharmaceutical Quality Systems, excellent written and oral communication skills, and ability to set personal performance goals and provide input to departmental objectives.
- Ability to multitask and easily prioritize work, proficient in Microsoft Excel, Word, and PowerPoint, and willing to work flexible hours, weekends, and off-shift hours as needed to support manufacturing activities.
- Bachelor's degree with 10 years of relevant experience in a regulated pharmaceutical, biotechnology, or supporting a CDMO environment; or Associate's degree with 12 years of relevant experience in a regulated pharmaceutical, biotechnology, or supporting a CDMO environment.
