Job Title: Inspection Readiness Lead
Industry: Pharmaceutical / Biotechnology
Job Type: Contract
Location: Ontario, Canada
Work Arrangement: On-site
Experience: 10+ Years
Duration: 12+ Months, with possible extension
Job Summary
We are seeking an experienced Inspection Readiness Lead to support pharmaceutical manufacturing and packaging sites in preparing for Health Canada and FDA regulatory inspections. The role will focus on inspection readiness, GMP compliance, quality remediation, documentation management, and inspection preparation for solid oral dosage manufacturing operations.
The successful candidate will lead inspection readiness planning, identify compliance gaps, coordinate mock inspections, prepare subject matter experts (SMEs), and ensure that site personnel, facilities, documentation, and quality systems are prepared for regulatory inspections. This position will work closely with Quality teams, the Project Management Office (PMO), and cross-functional stakeholders to address inspection readiness gaps and support ongoing quality improvement initiatives.
Key Responsibilities:
Inspection Readiness Planning: Develop and implement inspection readiness strategies, readiness plans, and risk-based assessments for pharmaceutical manufacturing and packaging sites.
Regulatory Compliance: Ensure site inspection preparation aligns with Health Canada GMP requirements, FDA regulations, and applicable international quality standards.
Mock Inspections: Plan and lead mock inspections, identify compliance gaps, document findings, and coordinate corrective actions to improve inspection preparedness.
Documentation Management: Prepare, review, and maintain inspection-related documentation, including site profiles, document indexes, readiness trackers, gap assessment logs, and inspection storyboards.
SME Training and Coaching: Identify and prepare primary and backup subject matter experts through training, mock interviews, and coaching on quality systems, manufacturing processes, and remediation activities.
Front-Room and Back-Room Coordination: Establish inspection logistics, document-room arrangements, facility tour plans, and processes for managing regulatory requests during inspections.
Quality Remediation Support: Support remediation initiatives related to FDA Form 483 observations, Warning Letters, Health Canada inspection findings, and other regulatory compliance issues.
Regulatory Commitment Tracking: Monitor regulatory commitments and readiness milestones in collaboration with the PMO and site Quality teams.
Gap Assessment and Closure: Identify inspection readiness gaps, assign follow-up actions, track progress, escalate risks, and ensure timely closure of outstanding issues.
Stakeholder Collaboration: Work closely with Quality Assurance, Manufacturing, Packaging, Engineering, and other subject matter experts to maintain inspection readiness across site operations.
Status Reporting: Provide regular progress updates, risk assessments, and readiness reports to the PMO and Quality Improvement Program (QIP) Steering Committee.
Quality Documentation and Record Management: Personally draft, review, and close inspection readiness documents and quality records in accordance with applicable GMP requirements.
Required Skills:
- 10+ years of experience in pharmaceutical GMP Quality, Quality Compliance, or regulatory inspection readiness.
- Proven experience leading FDA and/or Health Canada inspection preparation activities.
- Strong knowledge of pharmaceutical manufacturing, packaging operations, and GMP quality systems.
- Hands-on experience coordinating front-room and back-room inspection activities and document management.
- Experience planning and executing mock inspections, gap assessments, and inspection readiness reviews.
- Demonstrated ability to train and coach SMEs for regulatory inspections.
- Experience supporting quality remediation programs involving regulatory observations, Warning Letters, or similar compliance findings.
- Knowledge of Health Canada Food and Drug Regulations, Part C, Division 2, and GMP Guide GUI-0001.
- Working knowledge of FDA 21 CFR Parts 210, 211, and 11.
- Familiarity with ICH Q7, Q9, and Q10 and relevant PIC/S GMP guidance.
- Strong technical writing, documentation review, and quality record management skills.
- Excellent communication, organizational, problem-solving, and stakeholder management abilities.
- Ability to coordinate multiple workstreams and meet inspection readiness deadlines.
- Must be legally authorized to work in Canada and available to work on-site in the Greater Toronto Area.
- Willingness to complete required background checks and site-access training.
