Quality Assurance Manager

3 weeks ago

Montréal, Canada Groom & Associes Full time

**TITLE**: QA Manager

**LOCATION**: Saint-Laurent, QC

**INDUSTRY**: Pharmaceutical CDMO

Reporting to the Director of Quality Compliance, the Quality Assurance Manager Operation will be in charge of the quality programs linked to the manufacturing of pharmaceutical products. You will further develop, enhance, and maintain best practice quality programs and develop a consistent program across Montréal Facility. As the key point of contact for manufacturing quality-related matters, you will establish relationships with various teams across the organization as well as suppliers, customers, and governmental/regulatory bodies.

**Your Responsibilities with include**:

- Lead, coach, and mentor the Quality Assurance Pharmaceutical Operation team
- Ensure that QA personnel receive appropriate training to remain current regarding regulatory requirements
- Responsible for the overall Quality systems linked to the manufacturing of pharmaceutical products and enhancement to ensure compliance with existing and emerging national and international regulatory standards, customer expectations, and company expansion
- Responsible for safety, quality, and compliance to customer specifications
- Participate and/or investigate and respond to customer complaints in a timely fashion
- Perform root cause analysis and solution development and implementation
- Prepare and coordinate Audits
- Oversee raw material and supplier approval programs
- Assist in resolving issues with suppliers for quality problems with raw materials
- Ensures all employees are properly trained in hygiene and other technical issues
- Coordinate mock recalls, as well as Business Continuity Programs.
- Oversees raw material and finished product testing program
- Oversee the environmental testing and pest control programs
- Develop, implement and achieve certification on new quality and safety programs as required
- Work with the Technical Services to achieve continuous improvement of process and product quality.

**Skills and Qualification**:

- A Bachelors Degree in science or related discipline
- Minimum 7 years of a proven leadership experience in a manufacturing setting
- Strong working knowledge of GMP regulations, and experience with implementation, readiness, and compliance.
- Extensive experience with regulatory requirements within the pharmaceutical industry
- Ability to accurately define a problem, establish facts, draw valid conclusions, and determine appropriate corrective actions
- Confident in assessing risk and making recommendations to leaders based on a thorough risk assessment
- Proven experience in quality assurance, auditing, inspection methods in the food or pharmaceutical industry
- Experience in developing and implementing procedures, as well as food safety and quality standards.
- Strong computer skills. Comfortable using Microsoft Office Suite.
- Detail-oriented
- Strong organizational & prioritization skills
- Solid analytical and critical thinking skills
- Must be able to interact and collaborate with multiple departments
- Fully Bilingual, oral, and written

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