Senior Risk and Compliance Lead (Root Cause Analysis) Canada FSP
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.
Job Summary:
The Senior Risk and Compliance Lead / RCA Specialist will be accountable to train Sr / Issue Leads on the investigation/root cause analysis corrective/preventive action (CAPA) plan development and effectiveness checks for assigned Quality Events (QEs). This individual will also support as necessary the implementation of assigned plan components and tracking of actions and effectiveness checks to completion.
Key Responsibilities:
The Senior Risk and Compliance Lead / RCA Specialist will be responsible to:
- Lead the investigation/root cause analysis corrective/preventive action (CAPA) plan development for assigned cases
- Support implementation of assigned plan components and tracking of actions to completion as necessary
- Ensure documentation of root cause analysis and CAPA plan are accurate complete and inspection ready
Root Cause Analysis/Due Diligence
This individual will also be required to apply a root cause methodology and/or due diligence approach to the case. This individual may either lead QE cases from start to finish or be brought in conduct just the RCA portion of the investigation for systemic issues process related issue or business critical cases.
Training
This individual will also be required to train new Investigation Case Leads in the Root Cause Analysis Methodology and provide mentoring to new Investigation Case Leads while they obtain RCA Certification.
The Senior Risk and Compliance Lead / RCA Specialist will also be a subject matter expert in the Human Performance (PHP) methodology and will be a resource to case leads to implement PHP in the investigation process and help teams error proof the process in question.
CAPA Plan Development and Management
Based on identified root causes the individual will guide the SQE team in identifying appropriate corrective and preventive actions and conducting effectiveness checks on implemented actions to ensure they are working as expected.
Leverage process improvement best practice techniques (i.e. Six Sigma Lean etc.); analyze and optimize current business processes and develop and implement new business processes.
This individual will hold accountability for ongoing monitoring of CAPA completion and tracking of effectiveness for implemented mitigation actions to ensure they are working as expectedfor quality events inspections and audits
- Ensure implementation of QE / audit / inspection CAPAs and remediation plans
- Track effectiveness checks and report on trends.
Requirements:
- Minimum of 5 years of pharmaceutical experience with solid experience in clinical operations aspects GCP Quality GxP Quality and/or regulatory in a clinical research or pharma environment required
- Regulatory inspection experience
- Process and system management experience
- Detailed knowledge of clinical trial processes and relationships required
- Knowledge of GCP requirements and applicable SOPs and regulations
- Project management administrative and technical capabilities are required as well as effective verbal and written communication skills
- Strong background in continuous improvement methodology (i.e. Lean Six Sigma) preferred
- Previous Experience in conducting Root Cause Analysis Error Proofing/Mistake Proofing and familiar with Human Performance (PHP) and help analyze trends in data to identify potential investigations to address systemic process issues or program/protocol level issues.
- This role will involve working with Vendor Quality and Clinical Quality colleagues.
- Work with Vendor Quality and Clinical Quality groups to assist in developing investigation strategies related to vendor issues and program level quality issues.
- Experience in leading process improvement efforts from inception to execution
Education:
- Bachelors degree required
- Sigma Black Belt Required
#LI-CF1
Required Experience:
Senior IC
Key Skills
- Compliance Management
- Risk Management
- Financial Services
- PCI
- Banking
- Cost Accounting Standards
- Quality Systems
- Research Experience
- NIST Standards
- Securities Law
- SOX
- ISO 27000
About Company
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our the ... View more
