Position: QA Lead – On Site (with Smart Work flexibility)Salary Range: $101,500 – $135,300 per year.ResponsibilitiesMaintain and revise QA related procedures, as needed.Maintain cGMP training systems and perform on‑site team member training in Quality related matters.Ensure GxP support and oversight, as applicable, for relevant site functions and activities.Support QA team members with senior QA level knowledge, experience, guidance, coaching and mentoring, as required.Perform QA batch record review and disposition of manufactured early‑phase clinical product batches.Provide final QA approval of investigations and disposition of any impacted product batches.Evaluate deviations and propose batch rejections, if applicable.Perform QA review and approval of the following, as needed: environmental monitoring data in GMP cleanrooms and adjacent areas, as well as clean utility monitoring data.Investigate non‑conforming product.Investigate out‑of‑specification (OOS) results.Manage and approve Change Controls, as required for facilities, equipment, systems and processes, Corrective Action/Preventive Action (CAPA) and Deviations.Provide direct QA resources to support process development teams.Perform or support internal audits/self‑inspections.Perform or support qualification of suppliers.Perform QA review and approval of facility and equipment qualification protocols and final reports, cleaning verification protocols, and analytical test method validation documentation.Provide or support QA review and approval of analytical methods, standards and specifications.Support, coordinate and/or host customer audits as required.Support audit responses creation and execution, as needed.Effectively communicate with client QA personnel as project support.Provide QA support for development of validation strategies and validation plans, including Computer System Compliance (CSC)



efforts.Establish and manage QA tracking and trending of program measures and the preparation of periodic reports for management review.Maintain appropriate KPIs to monitor performance and improvement.Propose and develop continuous quality initiatives to improve efficiency and level of control and compliance.Support and promote the company safety program by obtaining and using personal protective equipment as appropriate, observing all safety procedures and practices, and ensuring that other employees use personal protective equipment.Perform other duties as may be required by management.RequirementsMinimum B.S. degree in chemistry, biology, microbiology, biomedical or chemical engineering or equivalent education.Preferably 10–12 years’ experience in Quality Assurance/Quality Control in the biopharmaceutical or pharmaceutical manufacturing industry, with at least 2 years in a leadership position.Experience with hosting foreign and domestic regulatory inspections (US‑FDA, EU authorities, Health Canada).Knowledge of cGMP requirements and application and interpretation for finished dosage forms.Robust organizational skills.Advanced problem‑solving skills.Advanced written and verbal communication skills.Excellent interpersonal skills.Strong leadership skills.Knowledge of Office software systems including Word, Excel and Access.Proven experience in pharmaceutical regulatory requirements.Additional CompetenciesResults Orientation– Redesign practices and processes for breakthrough results, significantly improve organization’s practices, processes and quality, and apply quality risk management principles.RoleOrientation / Strategic Orientation– Lead improvement areas, redesign processes, manage QA activities with best practices, support definition of standards for quality systems and compliance, facilitate cross‑functional collaboration, and demonstrate high emotional intelligence.Technical Proficiency / Business‑Focused Proficiency– Advanced supervisor level expertise in GMP requirements, change control, deviations, investigations, CAPA and risk assessments, with excellent judgement and technical competence to coach and mentor QA team members.#J-18808-Ljbffr

📌 Sr. Project Manager, Quality Assurance (Qa) - $101,500 - $135,300 A Year (Winnipeg)
🏢 0011 Evonik Canada Inc._11
📍 Winnipeg