Senior Biomanufacturing Quality Assurance Manager
7 days ago
We are looking for an experienced professional to lead our quality control team at Resilience, a cutting-edge biomanufacturing company.
The ideal candidate will have significant experience in supervisory or managerial roles within quality control and technical backgrounds in analytical methods, method validation, and GxP regulations. Strong leadership skills, attention to detail, and ability to work in a dynamic environment are essential.
This position offers a competitive salary range of $145,000.00 - $205,000.00 per year, based on qualifications, location, and experience. Our comprehensive benefits package includes equity, annual cash bonus program, RRSP/DPSP with generous company match, healthcare, dentalcare, vision care, life, LTD, and AD&D benefits, fertility healthcare, family-forming benefits, flexible time off, paid holidays, pregnancy and parental leave top-up plan, tuition reimbursement, and employee referral program.
About the Role:
- Lead the quality control team to ensure compliance with cGMP regulations, compendial requirements, company policies, standards, and procedures.
- Develop and maintain high-skilled teams to deliver accurate and timely testing results.
- Implement data integrity controls, manage reagents and reference standard management, instrument and equipment management, and laboratory systems.
- Partner with Digital Quality to ensure data integrity implementation.
- Manage deviation programs, CAPA development, and review personnel involved in investigations.
- Interface directly with clients for quality or compliance issues.
- Oversee lab change control programs, compendial reviews, and SOP approvals.
- Monitor departmental performance and quality metrics.
Requirements:
- Significant experience in supervisory or managerial roles within quality control.
- Technical background in analytical methods, method validation, and GxP regulations.
- Demonstrated problem-solving skills and attention to detail.
- In-depth knowledge of GxP regulations, particularly Health Canada, US-FDA, and EU guidance on data integrity and compendia.
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