Specialist I, Quality Compliance

Preparedness today, safer tomorrow.

Emergent is a leading public health company that delivers protective and life-saving solutions to
communities 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

The Specialist I, Quality Compliance is responsible for supporting and representing Emergent during regulatory inspections, customer audits, and internal audits. This includes coordinating audit and inspection activities, managing preparation and logistics, developing written responses, and ensuring timely completion of audit-related corrective and preventive actions (CAPAs).

The role is responsible for planning, conducting, and reporting internal audits; managing audit responses and CAPAs; and maintaining the site's regulatory intelligence and surveillance program. The position supports compliance with cGxP requirements and other applicable regulations and quality system activities at the Winnipeg site.

In addition, provides oversight of product complaints and inquiries, annual product quality reviews (APQRs), and quality agreements, ensuring adherence to regulatory, corporate quality requirements and established procedures.

Responsibilities

• Plan, schedule, and conduct internal quality system audits in accordance with the approved audit schedule, including review of previous audits, regulatory inspections, procedures, processes, and operational activities.
• Lead cross-functional audit teams, providing guidance, training, and day-to-day direction throughout the audit lifecycle.
• Prepare comprehensive audit plans, consolidate audit observations, and author clear and concise audit reports.
• Evaluate documentation, records, processes, and personnel practices to assess compliance with GxP requirements, regulatory expectations, and internal standards.
• Partner with functional area management to discuss audit findings, establish corrective actions, and drive timely resolution of identified compliance gaps.
• Verify CAPA effectiveness to ensure sustainable compliance improvements.
• Draft, review and maintain Quality Technical Agreements with customers and clients.
• Collect, analyze, and trend compliance metrics; prepare reports and present compliance performance and improvement initiatives during Management Review meetings.
• Support regulatory inspections through inspection readiness activities, participation in inspections, and coordination of post-inspection follow-up activities.
• Maintain current knowledge of applicable GxP regulations, industry standards, and regulatory trends, serving as a compliance subject matter expert for the site.
• Provide compliance assessments, recommendations, and guidance to support business operations and quality system effectiveness.
• Lead or participate in cross-functional projects as assigned, acting as the Quality Assurance representative and providing compliance expertise.
• Provide oversight and management of the site’s product inquiry and product complaint programs, ensuring investigations and responses are completed in accordance with regulatory and company requirements.
• Support continuous improvement initiatives aimed at enhancing quality systems, inspection readiness, and overall compliance performance.

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 or related degree
• Minimum of five (5) years of experience in the pharmaceutical, biotechnology, or other regulated life sciences industry with at least at least 4 years of experience within Quality Assurance or related Gxp function.
• Industry certifications or diplomas in Quality Management, Auditing, and/or Quality Systems considered an asset.
• Demonstrated experience conducting internal audits, managing CAPAs, and supporting regulatory inspections.
• Strong knowledge of cGMP and other applicable GxP regulations and quality systems.
• Excellent analytical, critical thinking, and problem-solving skills, with the ability to assess strengths, risks, and gaps within systems and processes.
• Demonstrated ability to work independently while effectively collaborating across departments and organizational levels.
• Excellent interpersonal and communication skills, including the ability to influence stakeholders and effectively navigate challenging discussions.
• Strong organizational skills with the ability to manage multiple priorities, analyze large volumes of information, and make sound compliance-based decisions.
• Proven technical writing skills, including the preparation of audit reports, compliance assessments, CAPAs, and quality agreements.
• Ability to make sound decisions regarding complex compliance-related issues with minimal supervision.
• Demonstrated accountability, professionalism, and commitment to quality and compliance excellence.
• Experience with aseptic manufacturing processes, cleanroom operations, and gowning qualification programs preferred.
• High level of personal and departmental accountability and responsibility.
• Strong understanding of pharmaceutical regulations and guidance, including ICH guidelines (Q1-Q14, as applicable), 21 CFR Parts 11, 210, 211, 600, and 640, Health Canada GUI-0001, and current industry trends.
• Experience supporting regulatory inspections by Health Canada, FDA, EMA, or other global regulatory authorities.

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.