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Senior Director of Quality
Location: Winnipeg, MB
Position Summary
Our client, a global leader in developing and delivering critical healthcare solutions, is looking for a Senior Director of Quality to oversee all quality assurance (QA) and quality control (QC) operations. This individual will ensure compliance with regulatory requirements, enhance quality systems, and foster a culture of continuous improvement. As a key member of the site leadership team, the Senior Director will align quality operations with business goals, ensuring product safety, efficacy, and regulatory adherence.
This position is onsite in Winnipeg, MB.
Key Responsibilities
- Lead and develop the quality team to foster excellence and collaboration.
- Set and implement the strategic vision for quality operations in alignment with corporate and site goals.
- Serve as the primary quality representative in interactions with regulatory agencies, customers, and internal stakeholders.
- Ensure compliance with Health Canada, FDA, EMA, and other global regulatory requirements.
- Manage and oversee regulatory inspections, audits, and follow-up actions.
- Maintain a robust quality management system (QMS) to meet cGMP and other applicable standards.
- Oversee quality assurance, quality control, and quality systems functions, including release testing, deviations, CAPA, change control, and document management.
- Implement and sustain quality metrics to monitor performance and drive improvements.
- Collaborate cross-functionally with manufacturing, R&D, and supply chain to ensure product quality throughout the lifecycle.
- Drive initiatives to improve quality processes, systems, and tools to enhance efficiency and effectiveness.
- Lead investigations into quality-related issues and implement corrective and preventive actions.
- Build a high-performing quality organization through recruitment, training, and professional development of staff.
- Provide mentorship and guidance to direct reports, ensuring clear goals, accountability, and opportunities for growth.
Qualifications
- Bachelor’s degree in a relevant scientific discipline (e.g., biology, chemistry, pharmacy); an advanced degree is preferred.
- 10+ years of progressive leadership experience in quality operations within the pharmaceutical or biotechnology industry.
- Extensive knowledge of global regulatory requirements, including cGMP, Health Canada, FDA, and EMA guidelines.
- Demonstrated success in managing regulatory inspections and audits.
- Proven ability to lead and inspire teams in a dynamic, fast-paced environment.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent communication and interpersonal skills, with the ability to work collaboratively across functions.
- Experience with biologics, vaccines, or sterile manufacturing.
- Six Sigma or Lean certification is a plus.
Thank you in advance for your interest, only individuals deemed to have the skill set and experience to fit the role will be contacted. Applicants must be legally entitled to work in Canada without sponsorship.
Lock Search Group is a National Executive Recruitment firm with a dozen offices in Canada, a staff of more than 50 Consultants and Associates, and expertise in 11 major disciplines. Our mission is to provide exceptional Recruitment and Consulting Services to clients and candidates. We apply our experience and expertise to deliver solutions with a personalized approach that focuses on client needs and candidate goals.
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