Job Description
This position is responsible for overall development, implementation, and maintenance of the organization’s Quality Management System (QMS).In addition, this position will report to the CEO and CSO with oversight by the Directors of Clinical, Manufacturing and Pre-Clinical Development. The Quality Manager will work in conjunction with Procurement, Manufacturing, and other departments that affect the quality of Forbius’s products.This position can reside in our Montreal, QC or Austin, TX office.
Key Responsibilities
- Ensure Forbius’s organization Quality Management System conforms to customer, internal and regulatory/legal requirements
- Ensure evaluation and reporting of vendor quality systems
- Manage the monitoring, measurement and review of internal quality processes
- Ensure for managing a solid documentation system supporting data integrity
- Audit internal regulatory systems to ensure regulatory audit readiness
- You will develop risk-based strategies and be responsible for the GLP, GMP and GCP compliance oversight of internal and external operations
- Work closely withCMC to review and release batches and ensure documentation requirements are complete
- Make recommendations to lead management on performance of QMS (e.g., quality audit results, corrective actions), including the need for improvement
- Responsible for ensuring SOP implementation, training and execution
- Responsible for employee training file maintain based on established guidelines by Department Director
- Maintain standards, regulations, issues and news with respect to product-service quality
Other Functions
- Occasional travel to vendor sites (10-15%) for audits, inspections, etc. may be required
- No heavy lifting is expected, though occasional exertion of 10-20 lbs. of force (e.g., carrying a laptop, binder or both) is required
Winning Behaviors, Competencies, and Skills
Define behaviors and values:
Quality managers must have proven ability to lead a diverse team. Excellent communication skills and the ability to work well with people at all levels are essential.
Personality and communication (soft skills):
Ability to communicate orally with customers, vendors, management and colleagues is crucial. Regular use of phone and email for communication is essential.
Hard skills:
Must have strong organizational, analytical, problem solving and management skills. Experience with MS Office (especially Excel, Word) is required. Project management experience is a plus.
Qualifications and Experience
Education and Work Experience:
A bachelor’s degree in engineering or quality is preferred, as is 5-10 years of experience in Quality Assurance/Quality Control.
Industry Knowledge:
Current CQA or similar certification is preferred.