RESILIENCE is creating the first sustainable ecosystem for advanced biopharmaceutical manufacturing. We’re building a robust, dynamic, and diverse network of manufacturing capability and talent – investing in innovation every step of the way.
We provide high-tech, end-to-end manufacturing and development solutions to ensure the medicines of today and tomorrow are accessible to all in need. This includes complex medicines, such as cell and gene therapies, viral vectors, and vaccines, as well as proteins and the next generation of medicines.
RESILIENCE believes in access to quality and innovation for all. Our adaptive facilities serve partners big and small. We continuously invest in R&D for next generation manufacturing and development, freeing our partners to focus on the discoveries that impact lives.
We offer customized and scalable processes, the highest quality and regulatory capabilities, and world-class facilities. Through manufacturing that is faster, more flexible, and less risky, we safeguard the quality of critical medicines and protect the resilience of a vital supply chain.
This job is responsible for Supplier Qualification and Management program and management of Quality Compliance Specialists team for Internal Audits, Quality Agreements, Risk Management Program, and Learning Management System administration. This role requires up to 20% travel, both domestic and international.
Supplier Qualification and Management Program:
- Maintain compliance to RESILIENCE’s procedures on supplier qualification and management.
- Review and approve new material requests with a verification of the material risk category.
- Initiate a supplier qualification process as per the material/service risk category.
- Review quality agreement and coordinate the approvals at RESILIENCE.
- Approve material / service provider upon completion of supplier qualification requirement.
- Work closely with the supplier/service provider to schedule an on-site supplier audit.
- Obtain material related information for supplier audits.
- Perform an on-site supplier audit, as per the approved audit schedule, of suppliers providing materials and components, laboratory audit with Subject Matter Expert (SME) (Manager, QC Chemistry and/or Manager, Microbiology), facility service provider audit with SME (Manager, Facilities and/or Engineering), and computer system service provider audit with SME (Manager, Validation and Manager, Quality Systems).
- Prepare and issue audit report. Provide the approved audit report to the supplier / service provider for corrective action initiation; follow-up with supplier / service provider for closure of the corrective actions.
- Maintain “Approved Material and Supplier List” (AMSL) file current; maintain Supplier and Laboratory Service Provide files with all required information.
- Manage material change notification process, assessments and change control impact evaluations
- Initiate, manage and resolve material complaint with the suppliers when defects are presented from Production and/or MSAT
- Work independently or in a team, either within QA (Quality Assurance) or with departments such as Purchasing, Raw Materials, MSAT, and Legal to ensure that all work is completed in a timely fashion to meet the quality, compliance, and business needs.
- Manage supplier performance management process
- Provide proactive role in moving quality & compliance goals forward throughout the organization and achieving positive and value-added results.
- Perform other job-related duties as assigned.
- Responsible for supervision of the Quality Compliance Team as defined.
- Escalate compliance concern to Quality Compliance management in a timely manner.
- Manage and/or perform internal audits, review, and approve the audit schedule and audit reports.
- Manage Quality Agreements
- Initiate and maintain RESILIENCE’s risk management program.
- Support in Learning Management System administration and training compliance.
- Provide required support in client audits and regulatory inspections.
- Perform other job-related duties as assigned.
TECHNICAL KNOWLEDGE / EXPERIENCE:
- University degree or equivalent in Science or Engineering and 3-5 years of QA experience.
- Previous experience in auditing, supplier management, and quality systems.
PREFERRED QUALIFICATIONS / EXPERIENCE:
- Auditor certification such as ASQ-CQA (Certified Quality Auditor)
- Track record of compliance achievements.
- Required knowledge of cGMPs such as Health Canada, FDA, EMEA requirements
- Knowledge of sterilization principles and standards, including gamma irradiation and ethylene oxide sterilization
- Pre-employment medical and medical re-examination performed every 2 years or as per RESILIENCE’s SOPs.
While we appreciate your interest in this opportunity, only qualified candidates will be contacted. Resilience Biotechnologies Inc. (RESILIENCE), will not be responsible for any agency referral fees arising from the use of resumes that currently exist in the recruitment database or have been forwarded to directly Resilience Biotechnologies Inc. (RESILIENCE), or indirectly without an authorized agreement. Agency referrals will not be accepted unless approved by the Resilience Biotechnologies Inc. (RESILIENCE), Human Resources team.
NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including pre-employment medical (where applicable), educational, employment, references, and criminal records checks (for which a pardon has not been granted).
Resilience Biotechnologies Inc. (RESILIENCE), is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process. Applicants are asked to make their needs/requirements known to Human ResourcesApply Now