Director, Quality Assurance
On-siteWinnipeg, Manitoba, Canada
Job Summary
Lead QA Operations, Quality Systems, and QA Validation teams to ensure products and validation activities comply with corporate standards, GMP requirements, and Health Canada or FDA regulations. Establish operational plans aligned with Global Quality goals, oversee the Global Quality Manual, and manage document approvals for intermediates, bulk products, and finished goods. Direct key quality processes, including test result reviews and specification approvals, while leading investigations for significant quality events and coordinating with cross-functional teams during crises. Act as the primary representative to regulatory agencies on quality matters, manage the department's annual budget, and champion continuous improvement to reduce compliance risk. Develop and mentor team members through hiring, performance management, and succession planning to build organizational capability.
Required Qualifications
- Bachelor's degree in Science, Pharmacy, Engineering, or a related field
- Minimum of ten (10) years of progressive experience in Quality, Regulatory, or GMP operations
- Significant senior management and people leadership experience
- Demonstrated ability to independently manage matters involving regulatory compliance
- Demonstrated ability to independently manage matters involving product acceptability
- Demonstrated ability to independently manage matters involving quality risk assessment
- Demonstrated ability to independently manage matters involving functional operations
- Ability to maintain an enterprise mindset
- Ability to apply an organizational lens to departmental decision making
- Excellent communication skills
- Excellent negotiation skills
- Excellent interpersonal skills
- Excellent management skills
- Excellent organizational skills
- Strong commitment to teamwork
- Strong commitment to empowerment
- Strong commitment to innovation
- Ability to build, maintain, and navigate relationships with stakeholders at all levels of the organization
- Ability to influence senior leaders on matters of significance
- Ability to translate technical details, regulatory and quality standards, and business judgment into clear requirements and actionable priorities
- Ability to apply sound decision making using cause-and-effect analysis
- Ability to apply sound decision making using corrective actions
- Ability to apply sound decision making using preventive approaches
Desired Qualifications
- An advanced degree
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