SENIOR DIRECTOR, QUALITY
FULL-TIME
PICKERING, ON
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
- Competitive Salary
- 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.
I really look forward to hearing from you, but please understand that I will only be contacting those that are applicable for the role!
Options Consulting Solutions is an equal opportunity employer and welcomes applications from all individuals. Applicants selected for an in-person interview will be asked whether specific accommodations are needed to support a personal disability.
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