Target Salary Range: $101,500 – $135,300 per year (salary to be determined by education, experience, knowledge, skills and abilities of applicant, internal equity, and alignment with market data) We are a contract development and manufacturing organization (CDMO) that provides CMC services to biotechnology and pharmaceutical companies, helping them develop and manufacture complex delivery-based drug formulations.
Responsibilities Maintain 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 for relevant site functions and activities.
Support QA team members with senior QA level knowledge, experience, guidance, coaching and mentoring. 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 environmental monitoring data in GMP cleanrooms and adjacent areas, as well as Clean Utility monitoring data. Investigate non-conforming product and out of specification (OOS) results.
Manage and approve change controls, corrective action/preventive action (CAPAs), and deviations for facilities, equipment, systems and processes. Provide QA resources to support process development teams. Perform or support internal audits/self-inspections.
Perform or support qualification of suppliers. Review and approve facility and equipment qualification protocols, cleaning verification protocols, and analytical test method validation documentation. Review and approve analytical methods, standards and specifications.




Support and coordinate or host customer audits as required. 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 prepare periodic reports for management review. Propose and develop continuous quality initiatives to improve efficiency and compliance. Support and promote the company safety program.
Perform other duties as may be required by management. Requirements Minimum B.S. degree in chemistry, biology, microbiology, biomedical or chemical engineering or equivalent education. Preferably 10-12 years of experience in Quality Assurance/Quality Control, preferably in the biopharmaceutical or pharmaceutical manufacturing industry, with at least 2 years in a leadership position.
Experience hosting foreign and domestic regulatory inspections (US-FDA, EU authorities, Health Canada). Knowledge of cGMP requirements and experience in their application and interpretation for finished dosage forms. Strong organizational, advanced problem-solving, written and verbal communication, interpersonal and leadership skills.
Knowledge of Office software (Word, Excel, Access). Proven experience in pharmaceutical regulatory requirements. Benefits Competitive base compensation and bonus. Employer paid health and dental advantages complemented with wellness education sessions.

Financial planning resources and savings plans including RRSP and Defined Contribution pension plans. Generous vacation and paid time off. Financial assistance for fitness memberships. Access to a Comprehensive Health Promotion program and regional and global resources for ongoing training and development.#J-18808-Ljbffr

📌 Sr. Project Manager, Quality Assurance (Qa) (Burnaby) - $101,500 - $135,300 A Year
🏢 Evonik
📍 Burnaby