Manage healthcare compliance by conducting internal group consultations, overseeing investigations, and ensuring adherence to regulations. Key responsibilities include interfacing with client QA departments, conducting policy and procedure reviews, and implementing training programs. Oversee audits, manage risk priorities, and ensure compliance with facility programs.

Provided leadership, coaching, and development to approximately 30 employees in the Quality Services Department. Optimized organizational structure to support optimal service delivery, and overall laboratory operations excellence. Built a high-performance team, and developed a culture of continuous improvement.• Provided quality and technical guidance to Analytical Development, Quality Control, Metrology, Technical Writing, and Microbiology, leading to successful client, FDA and Health Canada audits, and Public Health Inspection. • Analyzed and assessed the training and development need to create and deliver a training plan for each individual in Analytical Development, Quality Control, Metrology, Technical Writing, and Microbiology, leading to employee promotions, and increased employee retention. • Worked with Human Resources to attract, recruit, and retain talent – by assisting in the hiring process, leading the interview team, and ensuring successful onboarding of staff by welcoming employees, organizing training, delivering introductory slide presentations, and providing facility tours. • Established Key Performance Indicators (KPIs) for delivery, quality, cost, engagement, and safety with the implementation of a visual management system with summary reports, daily huddles, and problem-solving. • Ensured that all laboratory and GMP documents such as policies, change controls, CAPA, deviations, APQR, SOPs, protocols, and reports were completed in compliance with the company quality system.

Provided training, operation improvement initiatives and change leadership within Pharmaceutical Development Services (PDS) Analytical Development (AD) to improve departmental efficiencies, as well as manage lab operations to optimize right-first-time and on-time delivery metrics. Established resource capacity planning to support project timelines, manage client expectations, and ensure alignment between project execution and Sales Order Register.• Planned and implemented Lean Labs, which included training, daily huddles, metrics, and problem-solving, leading to a 15% efficiency gain.• Supported training and implementation of risk management at the site, and led problem-solving sessions using brainstorming and FMEA.• Trained and evaluated project supervisors to interpret data and provide scientific value to the clients, and attended project meetings to ensure that scientific value was provided to the clients.• Worked with and advised staff on administrative policies and procedures.• Led task force in writing and consolidating SOPs from the two Canadian sites.

Supported the Senior Leadership Team in Change Management, and in driving and developing a lean manufacturing culture by using Lean Six Sigma tools, including Kaizen, Standard Work, Value Stream Mapping, 5S, and Visual Management.• Managed and facilitated process improvement projects across sites in Canada and the US to achieve financial, operational, customer, and employee satisfaction.• Worked collaboratively with cross-functional teams from Quality Assurance, Project Management, Technical Operations, Analytical Development, and Quality Control to streamline and simplify processes.

Supervised, trained, and developed a team of 10 chemists. Provided 24/5 support to manufacturing, ensuring on-time equipment release into manufacturing. Supported development and validation of analytical methods to test residual, feasibility, release, and stability samples in accordance with cGMP and company SOPs.