Senior Director Quality Systems
7 days ago
We are seeking a highly experienced Senior Director Quality Systems to lead our Pharmaceutical Quality Systems team. As a key member of our organization, you will be responsible for developing, implementing, and maintaining our Pharmaceutical Quality Systems (PQS) to ensure compliance with regulatory requirements and organizational goals.
Key Responsibilities:- Develop and implement risk-based PQS to meet CGMP regulatory requirements
- Establish governance and oversight processes to ensure compliance with site and global quality standards
- Lead the Quality Systems team to deliver exceptional performance of each assigned sub-system
- 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
- 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 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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