Compliance Manager
Catalent Pharma Solutions
full-time
Posted on:
Location Type: Office
Location: Strathroy • 🇨🇦 Canada
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Host and directly manage Regulatory, Customer and Corporate audits at the Strathroy site.
- Prepare and facilitate responses to the observations arising from these audits and manage the follow up and closure of the corrective actions.
- Manage the Commercial Stability Program, ensuring compliant and efficient preparation of protocols, pulls of samples, execution of testing.
- Manage the Customer Complaint Investigation process, ensuring that the system functions to identify and prioritize significant product quality issues.
- Establish and lead the company process improvement teams to address identified product and process quality issues.
- Provide oversight for the Annual Product Quality Review program ensuring deliverables are on time.
Requirements
- Bachelor’s degree in relevant scientific or engineering discipline is required
- 3+ years of management experience in the pharmaceutical industry required; experience in manufacturing or GMP environments is a plus.
- Knowledge and experience in dosage forms involving gelatine encapsulation is a definite asset.
- Understanding of the overall business needs and objectives.
- Direct experience hosting and leading the preparation, management, and follow-up relating to FDA and Health Canada inspections.
- Ability to multi-task, prioritize and respond quickly to a changing regulatory environment.
- Demonstrable leadership experience at Catalent may be considered in place of external experience.
Benefits
- Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance)
- Group Retirement Savings –Registered Pension Plan (RPP) with employer contributions.
- Employee Reward & Recognition programs.
- Opportunities for professional and personal development & growth including tuition reimbursement.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory audits managementcustomer complaint investigationcommercial stability program managementGMP knowledgegelatine encapsulationproduct quality reviewprocess improvementcorrective actions managementtesting executionprotocol preparation
Soft skills
leadershipmulti-taskingprioritizationadaptabilitycommunication
Certifications
Bachelor’s degree in scientific disciplineBachelor’s degree in engineering discipline