Assistant Cost Manager supporting Arcadis’ rail and linear infrastructure programs across Ontario. Managing forecasting, earned value reporting, cost baselines, and change control.
About the role
- Supply and Audit Director leading GMP audits, supplier qualification, and regulatory inspections for Grifols’ Canadian plasma healthcare operations. Ensuring cGMP compliance, quality-system effectiveness, and product safety.
Responsibilities
- Develop, manage and oversee a global risk-based audit program for Grifols Canadian Plasma GMP activities
- Participate in risk-based GMP internal and external audits
- Lead auditing and supplier qualification personnel training and development programs
- Oversee and provide feedback to Quality Audit specialists and report risks and actions to senior management
- Provide quality direction on regulatory updates affecting the GMP audit program
- Develop and implement systems and processes supporting global audit and quality assurance requirements
- Support regulatory inspections, notified body audits, and other external audits
- Establish an internal audit program for compliance with Canadian regulations, cGMP requirements, FDA and European standards
- Assess supplier change notifications with related departments
- Maintain and supervise Quality Agreements with critical suppliers
- Manage new and renewal site certifications, including operational license, GMP and IQPP
Requirements
- Bachelor's Degree in Health-related Sciences, preferably in Pharmacy
- Post-Graduate Certification in Quality Management
- Proven experience in GMP auditing within a Pharmaceutical Company is preferred
- Knowledge of GMP requirements preferred
- Auditor certification
- Minimum of 10 years of general experience
- 6 years performing quality audits in a GMP environment within the pharmaceutical industry
- Proficiency with computers using Microsoft Office
- Organized and able to manage time effectively
- Ability to work within a highly regulated, labor-intensive environment
- Analytical and enquiring mind with the ability to interpret data and facts
- Excellent oral and written communication skills to produce clear and concise factual findings and the ability to present effectively to groups
- Effective organizational and planning skills with the ability to meet deadlines required
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