Sr. Project Manager, Quality Assurance (QA) (Burnaby)

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 benefits 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.