Position Summary:As Inspection Readiness Associate - Quality Compliance, at OmniaBio, you will be responsible for all aspects of inspection readiness including client audits and regulatory inspections. You will ready the organization for audits and inspections through a variety of initiatives, using quality metrics, self-inspection (internal audit), and regulatory intelligence. The role will liaise closely with all team members operating in the Good Manufacturing Practices (GMP) environment, along with external stakeholders and regulators. You will be a key member of the Quality Compliance team.
Responsibilities:- Maintains a high level of expertise in GMP compliance with respect to cell and gene therapy manufacture and well as all aspects of GMP compliance.
- Plans for all client and regulatory audits including setting agenda and timing
- Organizes SMEs and functional representation for all audits
- Works closely with business unit leaders to ensure that OmniaBio are audit ready all all times
- Works closely with business unit leaders and SMEs to ensure that audit responses and commitments are complete within the allotted time(s).
- Hosts health authority and client audits where applicable
- Maintains current understanding of GMPs and evolving regulations, and owns OmniaBio's compliance standards.
- Engages and supports the OmniaBio Operating Model continuous improvement philosophy.
Requirements:- Bachelor of science degree in science or engineering.
- 5-10 years of equivalent industry experience.
- Must have knowledge of compliance aspects of cell and gene production, sterile manufacture and overall GMP knowledge.
- Experience hosting client and regulatory audits
- Experience preparing responses to audits and managing audit commitments
- Excellent understanding of Health Canada/U.S. Food and Drug Administration GMP regulations and QA principles.
Desired Characteristics:- Capable of managing multiple projects.
- Strong presentation skills and English written and oral communication skills.
- Experienced in driving results by influencing others in a highly cross-functional environment.
- Demonstrates a collaborative and enabling management style.
OmniaBio is a developing organization and represents a fluid working environment. Flexibility and adaptability are essential, and duties will be influenced by the needs of the organization.
Applicants must be legally eligible to work in Canada.
An applicant's compensation package is finalized once the interview process is concluded and accounts for the nature of the role as well as the experience, competencies (job knowledge, skills and abilities) of the applicant and internal equity.
