Director, Quality Assurance

Job summary

The Director of Quality Assurance leads QA Operations, Quality Systems, and Validation for the Winnipeg site to ensure compliance with GMP and health authority requirements. This role provides strategic leadership for inspection readiness, risk management, and the escalation of significant quality issues.

Job details

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions tocommunities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.Job Summary Reporting to the Sr. Director, Quality, the Director, Quality Assurance leads QA Operations, Quality Systems, and QA Validation for the Winnipeg site. This role is accountable for ensuring products, services, and validation activities comply with Emergent quality standards, GMP expectations, and applicable Health Canada, FDA, and other health authority requirements. The Director provides strategic leadership for inspection readiness, continuous improvement, quality risk management, and escalation of significant quality issues, while promoting a culture of quality, compliance, accountability, and Emergent’s core values. Responsibilities Functional Leadership• Leads QA Operations, Quality Systems, and QA Validation teams.• Ensures products, services, and validation activities comply with corporate quality standards, GMP requirements, and applicable regulatory expectations, while remaining aligned with the company’s business strategy.• Establishes operational plans with clear objectives aligned to Global Quality and Site Operational Plan goals. Contributes to quality improvement initiatives and communicates quality strategies, key quality concepts, and regulatory requirements effectively across the site.• Oversees implementation of the Global Quality Manual and associated quality standards through effective quality processes, approval of Standard Operating Procedures and master batch records, and management of quality metrics.• Directs key quality processes, including approval or rejection of intermediates, bulk products, and finished products; review of test results; evaluation of batch and production records; approval or rejection of specifications, sampling instructions, test methods, and QA procedures; and implementation of a controlled document system.• Works with Global Quality team on development, implementation, and maintenance of global quality systems. • Ensures timely completion of GMP commitments to regulatory authorities.• Creates and manages the department’s annual budget, including resource planning and prioritization to support business and compliance objectives.• Champions change and continuous improvement to strengthen quality system effectiveness, improve efficiency, and reduce or prevent regulatory compliance risk.• Partner with the manufacturing team on operational initiatives and development projects.• Leads investigation and escalation processes for significant quality events, coordinating with cross-functional teams during high-priority or crisis situations.• Applies technical expertise and quality judgment to assess impact on product quality, set priorities, and determine appropriate courses of action.• Ensures a safe, compliant, and productive workplace for team members, premises, and equipment. People Leadership• Develops, coaches, and mentors team members to achieve organizational goals, build capability, and support business excellence.• Optimize resources and build team effectiveness to create efficiencies and synergies. • Demonstrate accountability and promote core values through leading the team by example in overcoming challenges to key deliverables.• Leads the quality team through effective hiring, performance management, training, talent development, and succession planning. External Stakeholders• Acts as a representative of Emergent with FDA, Health Canada, and other regulatory agencies on quality-related matters, coordinating with the business to maintain, resolve, or improve Emergent’s compliance standing.• Advocate for the customer and influence senior management on critical customer issues. The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. Education, Experience & Skills• Bachelor’s degree in Science, Pharmacy, Engineering, or a related field. An advanced degree is considered an asset.• Minimum of ten (10) years of progressive experience in Quality, Regulatory, or GMP operations, including significant senior management and people leadership experience. Demonstrated ability to independently manage matters involving regulatory compliance, product acceptability, quality risk assessment, and functional operations.• Ability to maintain an enterprise mindset and to apply an organizational lens to departmental decision making.• Excellent communication, negotiation, interpersonal, management, and organizational skills.• Demonstrates a strong commitment to teamwork, empowerment, and innovation to drive performance.• Builds, maintains, and navigates relationships with stakeholders at all levels of the organization, including influencing senior leaders on matters of significance.• Translates technical details, regulatory and quality standards, and business judgment into clear requirements and actionable priorities.• Applies sound decision making using cause-and-effect analysis, corrective actions, and preventive approaches.There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy.

What you’ll do

The Director of Quality Assurance leads QA Operations, Quality Systems, and Validation for the Winnipeg site to ensure compliance with GMP and health authority requirements. This role provides strategic leadership for inspection readiness, risk management, and the escalation of significant quality issues.

Requirements

Requires a Bachelor's degree in Science, Pharmacy, or Engineering and at least ten years of progressive experience in Quality, Regulatory, or GMP operations. Candidates must have significant senior management experience and the ability to navigate complex regulatory environments.

Benefits

• Competitive Salaries
• Flexible Work Arrangements
• Extensive Benefits Package

Listed skills

• Continuous Improvement · Preferred
• Validation · Preferred
• Quality assurance · Preferred
• Leadership · Preferred
• Health · Preferred
• Compliance · Preferred
• Risk Management · Preferred
• management · Preferred
• Assurance · Preferred
• Development · Preferred
• batch · Preferred
• Customer · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• QA Operations
• Quality Systems
• QA Validation
• GMP Compliance
• Inspection Readiness
• Quality Risk Management
• Regulatory Affairs
• Budget Management
• People Leadership
• Strategic Planning
• Change Management
• Cross-functional Coordination
• Performance Management
• Stakeholder Management
• Cause-and-Effect Analysis
• Corrective and Preventive Actions
• Influencing Skills
• Influencing Without Authority
• Accountability
• Organizational Skills
• Advocacy
• Talent Development
• Quality Improvement
• Quality Management Systems
• Budgeting
• Management
• Good Manufacturing Practices
• Decision Making
• Communication
• Regulatory Compliance
• Continuous Improvement Process
• Empowerment
• Standard Operating Procedure
• Leadership
• Innovation
• Risk Management
• Negotiation
• Operations
• Quality Assurance
• Quality Management
• Regulatory Requirements
• Sampling (Statistics)
• Resource Planning
• Risk Analysis
• Safety Assurance
• Business Strategies
• Strategic Leadership
• Succession Planning
• Team Effectiveness
• Test Method

Job areas

• Management & Leadership
• Healthcare
• Manufacturing
• Science & Research
• Engineering
• Director of Quality Assurance
• Management and Organization Analysts
• Quality Control Systems Managers
• Industrial Production Managers

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