Head Quality Assurance

4 weeks ago

Toronto, Canada LAI Full time

Our direct client is looking for a **Head of Quality Assurance **that has a background with **In Vitro Diagnostics (IVD)**

A well funded, early stage _**in vitro**_ **diagnostics (IVD)** company is seeking an energetic leader to manage and lead its quality assurance efforts. Specifically, the company is exiting Phase 2 of its product develop process and readying for clinical trials in 2025 for its multi-analyte POC instrument system and reagents. The QA team is currently small but is expected to evolve and grow within the coming year, led by this individual.
- **Position: Head of Quality Assurance**:

- **Full-Time Direct Hire Salary**:

- **Client Location: Toronto, Ontario Canada **area**

The Client really needs this position to work Onsite. Open to onsite options:

- Be in the office full time
- or wiling to be in the office 3 days a week
- or 2/4 weeks a month for the next 18 months and they can revaluate once they are submitted to the FDA

The client is open for either USA (United States) or Canadian Citizen. The client does have the travel budget.

Our client is seeking an organized and energetic individual to lead the company in implementing our Quality Management System (QMS) and embracing a quality mindset. As the Head of Quality Assurance, you will lead the company's QMS, ensuring rigorous compliance with global standards and driving a strategic approach to quality. You will implement, monitor, and continuously improve quality assurance processes, aligning with Health Canada, FDA, and EU regulations and corporate policies. This position will provide oversight across the full product lifecycle, from development to commercial operations, supporting teams in assay, consumable, instrumentation, manufacturing, and operations.

**Skills Required**:
**Education**: Bachelor’s degree in Science, Engineering, or a related field. Advanced degree preferred.

**Experience**:

- Must have hands-on experience working with an **In Vitro Diagnostics (IVD) **company in Quality Assurance
- Hands on work experience with _in vitro diagnostic_ (IVD) devices.
- Extensive cGMP and regulatory experience.
- Strong knowledge of quality management practices, cGMPs, and current trends in quality and regulatory compliance, especially across reagents/chemistry, consumables, and instrumentation.
- Experience Managing team, hands on manager, grow, mentor, coach, guide
- 10 + years pf overall experience in quality assurance within: pharmaceutical, biotechnology, medical devices, or In V_itro_ Diagnostics (IVD),
- Working in a startup, understanding Change Control Lite - Nice to have
- Implement or build out a QMS System - Nice to have
- Exceptional organizational and leadership abilities, with a proven track record in quality assurance management. Strong communication skills for effective debate, persuasion, and collaboration across teams.

**What you'll do**:

- **Quality Management System Leadership**:
Oversee and manage the organization’s QMS, ensuring full compliance with all relevant regulatory standards and guidelines, including Health Canada, FDA, and EU regulations.
- **Strategic Quality Assurance**:
Develop and execute a strategic approach to quality assurance, aligning with corporate objectives to enhance product quality and operational excellence.
- **Process Harmonization**:
Design, implement, and continuously improve standardized quality processes across the organization, securing buy-in to drive adoption and adherence.
- **Compliance & Standards Alignment**:
Keep quality system instructions and procedures current, ensuring alignment with the latest medical device standards and regulatory expectations across global and internal guidelines.
- **Cross-functional Collaboration**:
Work closely with assay, consumable, instrumentation, manufacturing, and operations teams, guiding them in quality assurance practices and implementing the QMS effectively across all areas.
- **Issue Resolution**:
Identify and communicate compliance and quality issues, proposing and implementing effective solutions with senior leadership.
- **Mentorship & Leadership**:
Foster growth and development within the quality team, providing mentorship and leadership to drive excellence in quality practices.
- **Skill Development**:
Assess, manage, and enhance skill sets and competencies within the quality team and across the organization.

**What you'll get**:

- **Impactful Work**:
An opportunity to change the face of medical diagnostics and drive transformative advancements in healthcare.
- **Collaborative Environment**:
Work alongside a high-performing, motivated team passionate about quality and innovation.
- **Competitive Compensation**:
A competitive salary and benefits package designed to attract and retain top talent.
- **Growth-Oriented Culture**:
An environment where your talent, ideas, and expertise are valued every day, empowering you to make meaningful contributions and thrive professionally.

Please Note, I am a United States Recruit

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