Work location – Halifax, NS or Quebec City, QC
We are searching for an experienced Compliance Manager to join one of Canada’s leading life sciences organizations, where you will have the overall responsibility of managing and executing our clients GxP Audit and Vendor Management Programs. Based in Halifax, NS OR Quebec City, QC, and reporting to the SVP of Quality & Compliance, you will take the lead on the development/implementation and execution of Investigation and Risk Assessment and be accountable for the overall assessment of compliance for pre-clinical and clinical studies (GLP/GCP compliance) and for all GMP manufacturing and testing activities.
- Ensure compliance across the organization by sustaining a level of constant inspection readiness to meet regulatory requirements, guidelines and industry standards.
- Manage the Internal and External Audit Schedules/Programs and oversee the execution of the remediation responses to ensure progress. Compiles all audit findings and monitor for signals and trends.
- Manage audit CAPAs to ensure that corrective and preventive actions are identified and implemented
- Identify potential compliance issues and develop strategies and procedures for ensuring compliance with the applicable regulations. Escalate regulatory compliance risks to Quality, Regulatory and Clinical Leadership to ensure that all issues are mitigated in a timely manner.
- Implement an Inspection Readiness Program that proactively prepares the site for Health Authority inspections (training, pre-audit preparation, tools, hosting, close-out etc.).
- Manage the Vendor Qualification Program, which includes the vendor approval and qualification process, maintenance of the Approved Vendor List, and oversee the management for creation/response to vendor questionnaires.
- Provide guidance, interpretation and information pertaining to GxP regulations and guidance to internal staff and contract manufacturing service providers.
- Assist the business in reviewing, selecting, and qualifying external GMP/GCP/GLP vendors and service providers.
- In Collaboration with QA Manager, authors and negotiates terms of Quality Agreements with service providers and vendors, and ensure their adherence to the signed Quality Agreement.
- Provide Compliance review/approval, in collaboration with QA, on Cleaning Validation program, process validation or verification program, computer system validation program, equipment calibration and qualification program, facility, utility
- Lead/Perform investigations of significant event deviations along with the corresponding root cause analysis (RCA), impact assessment and trend evaluations.
- Supplement and develop internal SOPs, policies and procedures as required
Our Ideal Candidate Brings:
- Bachelors’ degree in Biopharmaceuticals, Biochemistry or related field required
- Certification as a quality auditor (CQA) is preferred
- 8+ years of QA, compliance, and/or auditing experience in an ICH/FDA/GxP regulated setting (Pharmaceuticals or Biotech industry).
- In-depth knowledge of principles and guidelines related to ICH GCPs, 21CFR Part 11, FDA, GxP and International Conference on Harmonization (ICH) guidelines, as well as applicable government regulations related to biological product development and clinical trial regulation.
- Current knowledge of US FDA Regulations and ICH Guidelines governing clinical trials and recent global regulatory initiatives
- Global exposure from clinical study initiation through commercial products approval.
- Experience with outsourced manufacturing and testing operations
- Strong knowledge of regulatory compliance and QA issues within pharmaceutical or biotech
- In-depth knowledge of principles of quality management systems (QMS) and associated processes.
- Ability to identify and/or resolve quality and compliance issues.
- Experience with risk assessment and management methods, tools, and techniques
- Proficient level computer skills and in-depth knowledge of Microsoft Office applications including Excel, Word, and PowerPoint
- Knowledge and understanding of various software packages commonly used in GxP environments (Microsoft Office, LIMS, SAP, TrackWise, IDEA,etc)
- Strong technical writing skills
- Excellent written and verbal communication skills
- Strong organization, analytical, problem-solving and time management skills
For additional details regarding this unique opportunity, please send your resume to [email protected] or call directly: 902 405 3607
Summit Search Group would like to thank everyone who applies but only those whom match the requirements will be given follow up communications.
If your qualifications are a match for this position please apply online for immediate consideration. Thank you for your application.