Director, Quality Assurance

Emergent Biosolutions•Winnipeg, MB

About The Position

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.

Requirements

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, 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.

Nice To Haves

An advanced degree is considered an asset.

Responsibilities

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.
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.
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.