Senior Director of Pharmaceutical Quality Systems
5 days ago
We are seeking a highly experienced Senior Director of Pharmaceutical Quality Systems to join our team at FUJIFILM Holdings America Corporation. In this role, you will be responsible for developing, implementing, and maintaining the Pharmaceutical Quality Systems (PQS) for our company.
Key Responsibilities- Lead the Quality Systems organization to create a strong quality culture of engaged and motivated staff maintaining strong working relationships with internal and external stakeholders.
- Direct the Deviation, CAPA, Change Control, Supplier Quality, Document Control, QA Validation, eQMS, and Quality Management sub-system owners.
- Ensure the site PQS is aligned with the harmonized global FDB PQS, organizational goals and objectives, and areas of continuous improvement.
- 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 PowerPoint.
- Experience with MasterControl, Veeva, Blue Mountain, SAP, and Trackwise.
- Experience within CDMO.
- Advanced Degree.
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.
We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state, or local law.
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