EDUCATIONAL AND EXPERIENCE REQUIREMENTS:

• Associate’s Degree required. Bachelor’s Degree within a Science and/or Engineering field preferred.
• 5+ years in a cGMP quality/manufacturing role in a pharmaceutical, food or cosmetic environment with 1+ years of experience in leadership required.
• Experience in management of a team in a regulatory environment
• Experience in cGMP principles pertaining to investigations and CAPA
• Expertise in technical writing skills
• Expertise in practical problem solving and continuous improvement projects
• Experience in direct communication with clients and regulatory authorities
• Proficient in Microsoft Suite (Word, Excel, PowerPoint)
• Knowledge of adult learning methodologies; ability to coach and train others

• Collaborate with Subject Matter experts (SME), providing independent and objective quality advice supporting business procedures managed by SMEs.
• Provides Quality oversight related to continuous improvements (CI) associated with our QMS through metrics and key performance indicators.
• Present investigation findings in review boards (Deviation or CAPA) as well as to the impacted customers
• Supports the Business Process Owner network by ensuring risk-based improvements to procedures to ensure that they are simple, efficient, and fit for purpose while maintaining regulatory compliance.
• Lead a team of personnel ensuring team’s organizational performance and succession planning
• Direct and prioritize the investigations team to ensure regulatory requirements, client commitments and business needs are met
• Foster a culture of strong employee engagement, collaboration, flexibility, and competitiveness by improving competence, industry understanding, and executional skills
• Administer and oversee Thermo Fisher Scientific’s investigation and CAPA computerized systems access, etc.
• Mentor and train the staff members on investigation process
• Provide investigation guidance and expertise for complex deviations to all teams on site
• Supports a robust regulatory intelligence system by monitoring changing regulations and ensuring that the BPO network incorporates changes efficiently and timely