Accountable for the overall health of the Quality System documentation change control and compliance training processes. Directs strategy for the maintenance of the Quality System documentation and training plans to industry regulation, and organizational and business models. Directs compliance and continuous improvement projects related to documentation change control and compliance training within and across functional boundaries.
Key Responsibilities Include:
- Stays abreast of internal and external organizational, business process, and industry regulation-related changes. Understands, communicates, and tracks the impact of such changes on the Quality System documentation.
- Establishes Quality System documentation maintenance and optimization strategies.
- Responsible for metrics monitoring and reporting KPIs to Leadership.
- Collaborates across functional boundaries to harmonize documentation change control and compliance training business processes.
- Leads direct report employees and/or the oversight of contract/consultant personnel as needed.
- Required Education: Bachelor's degree
- Preferred Education: Advanced Degree and/or Certifications a plus
- Required Experience: 7+ years related experience; Proven 5 years in a leadership role with strong management skills; Experience working in a complex and matrixed environment; Strong communication skills, both oral and written; Strong business acumen and negotiation skills; Demonstrated ability to lead multi-divisional and multi-functional teams with global aspects.
- 5+ years related experience; 5+ year pharma, health care, or regulated industry; Higher education may compensate for years of experience; Strong/demonstrated knowledge of pharmaceutical regulations, i.e. FDA and European Union (Quality role).
- Mastery level experience with quality system and training documentation; Demonstrated ability in dealing with global communications and interactions; Excellent organizational skills and strong oral and written communications skills.