Senior Director Quality

Options Consulting Solutions; Pickering; On-site; CAD 120,000 - 140,000; Full time

Job summary

An established industry player is seeking a dynamic leader to oversee quality strategy and operations in a cGMP environment. This pivotal role involves ensuring regulatory compliance, driving quality initiatives, and enhancing quality systems across the product lifecycle. With a focus on innovation and continuous improvement, you'll collaborate with cross-functional teams and regulatory authorities to maintain the highest standards of quality. If you have a passion for quality in the pharmaceutical sector and a proven track record in leadership, this is an exciting opportunity to make a significant impact in a high-growth organization.

Benefits

Generous Vacation and Benefits from day 1

Bonus & Profit Sharing

Qualifications

• 10+ years of leadership experience in regulated industries.
• Strong command of GMP and global compliance standards.

Responsibilities

• Oversee quality strategy and operations in a cGMP setting.
• Ensure regulatory compliance and drive continuous improvement.

Skills

Leadership in pharmaceutical industry

GMP compliance

Quality Management Systems (QMS)

Regulatory compliance

Quality Improvement

Audit Experience

Validation Expertise

Agile methodologies

Document Control

Production Oversight

Education

Bachelor's degree in Pharmacy, Science, or Engineering

Master's or PhD preferred

Job description

Do you have 10+ years of leadership experience in pharmaceutical, medical device, or regulated health industries, with a strong command of GMP and global compliance standards?

Have you successfully led enterprise-level quality strategies, including oversight of QMS, CAPA, deviation management, and regulatory audits?

Are you looking to make a strategic impact in a high-growth environment where quality and innovation are at the forefront?

The Company

Our client is a fast-growing Canadian-based organization specializing in contract development and manufacturing services (CDMO) for next-generation products in the regulated wellness and pharmaceutical space. The company operates within a state-of-the-art, GMP-certified facility, delivering end-to-end solutions from R&D and product innovation to large-scale commercial production. With a focus on compliance, quality, and speed-to-market, they support both established and emerging brands across international markets.

Company Perks and Rewards

• Generous Vacation and Benefits from day 1
• Bonus & Profit Sharing

Must Haves

• Audit Experience: Direct involvement with Health Canada audits; FDA audit experience is a strong asset.
• Regulatory Compliance: Proven ability to implement process and policy changes in line with Health Canada regulations.
• Validation Expertise: Hands-on validation experience in facilities, equipment, and manufacturing processes.
• Quality Improvement: Skilled in driving quality initiatives, including investigations, metrics, and compliance improvements.
• Production Oversight: Experience on the shop floor, including batch release responsibilities.
• Document & Training Control: Strong background in managing document control systems and employee training programs.
• Agile Environment: Familiarity with Agile methodologies in a quality or production setting.
• Leadership & Ownership: Demonstrated ability to lead and take full ownership of a Quality Division.
• QC Lab Proficiency: Practical experience working in a Quality Control laboratory setting.
• Qualifications & Tenure: Minimum 10 years in QC/QA with at least 5 years in management; hands-on leadership style with at least 2 years in pharma or nutraceuticals; Bachelor’s degree required, Master’s or PhD preferred.

The Job!

We’re seeking an innovative and hands-on leader to oversee enterprise-wide quality strategy and operations in a cGMP pharmaceutical setting. This high-impact role is critical to ensuring regulatory compliance, driving continuous improvement, and enhancing quality systems throughout the product lifecycle.

• Develop and implement a comprehensive quality strategy aligned with global regulatory requirements
• Lead Quality Assurance operations, including validation, qualification, calibration, and compliance systems such as CAPA, change control, deviations, and OOS
• Ensure the organization remains inspection-ready and effectively manage internal audits, external audits, and regulatory inspections
• Promote a culture of continuous improvement through data-driven risk assessment and process optimization
• Provide strategic direction to cross-functional quality teams while supporting the growth and development of staff
• Maintain robust governance structures for risk management and compliance
• Collaborate closely with manufacturing, operations, and external partners to integrate quality throughout the organization
• Foster strong relationships with regulatory authorities, customers, and industry stakeholders

What you bring to the job

You are someone with a Bachelor’s degree in Pharmacy, Science, or Engineering and strong communication skills. You also come with:

• Advanced degree or Ph.D. preferred
• 10+ years of leadership experience in pharmaceutical, medical device, or healthcare industries
• Deep knowledge of GMP, QMS, regulatory requirements (FDA, Health Canada), and quality system design
• Proven ability to lead cross-functional teams and deliver enterprise-level initiatives
• Strong strategic thinking and problem-solving skills

Qualified job seekers are asked to apply with attention to Karyn Saunders. Reference # 13365.

Expected Compensation: $120,000.00 - $140,000.00.