Quality management system development and improvement;
- Facilitating and managing change in process, practices and culture;
- Overseeing quality and manufacturing operations;
- Regulatory compliance remediation:
- Responding with 483 observations, untitled and warning letters;
- Developing and managing remediation programs;
- Data integrity audits and remediation;
- Performing audits- for remediation, PAI and GMP inspections (FDA, EMA, WHO).

- Collaborating with consensus standards organizations, and establishing technical committee E55 in ASTM.
- Auditor: Submissions, and Review process. Change champion within FDA. Change facilitator within pharmaceutical industry.
- FDA Training facilitator: establishing curricula at Universities for FDA training; changing the FDA training philosophy and practices. Multi-disciplinary, multi-focused player and influencer.

- Trouble Shooter, Problem Solver, Change Agent: working with development, manufacturing and quality functions: problem solving, development and implementation of PAT, devising regulatory strategy, undertaking feasibility studies, equipment specification, and project management.
- Lead the design and construction of the first PAT system and network within a facility: Defining the critical aspects- process parameters, material attributes, data management system and control philosophy.