When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's 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 we're committed to making a difference.
Home Based, US or Canada
Parexel's Root Cause Analysis Lead will support the development & continuous improvement of key components of the Quality Management System (QMS) & related standards. In addition, you will define & supervise the Root Cause Analysis (RCA) process ensuring cross functional integration for non-conformities resolution to achieve customer satisfaction & avoid issues recurrence. You will support the prevention of Quality Events (Quality Issues & Audit Findings). You will guide teams managing the Root Cause Analysis of QE within the defined timeline & provide recommendations for business improvements.
Key Accountabilities:
Global Organization Support
- Assist to implement, maintain and continuously improve services required to support Parexel globally with regards to Quality
- Support Operations staff in the use of automated quality systems; summarize quality systems reports & provide metrics as appropriate
- Facilitate investigation & remediation of quality events
- Provide RCA support using performance improvement tools & methodologies
- Utilize electronic QMS tools to document & communicate status of RCA
- Establish & maintain collaborative relationships with internal customers to obtain information & content to ensure successful RCA completion
QMSO Support
- As assigned, complete QMSO goals for the key QMS elements
- Maintain a familiarity with Parexel QMS-related applications & related processes
- Participate in projects & initiatives, including reporting information & escalations as needed
- Define, coordinate & supervise the RCA end to end procedure
- Provide technical knowledge
- Work closely with Quality teams to ensure high quality & consistency on issue resolutions & trade off decisions for critical RCA's
Parexel Quality Department Support
- Work with Corporate Quality to develop and/or update quality/process documents, tools, & templates.
- Track & manage the cost of poor quality associated to the issues correlated to RCA
- Effectively communicate & provide RCA reports/presentations for leadership
- Work with relevant training functions including Learning & Development & Operations. Assist with the development of training materials as needed
Skills:
- Excellent interpersonal, verbal & written communication skills
- Proven RCA discipline expertise
- Ability to break down complex issues, determine possible actions & enable effective decision making
- Consensus builder among teams & cross functional groups with differing objectives & priorities
- Customer focused approach to work
- Strong leadership & ability to analyze & interpret data
Experience:
- 3 - 6 years' work experience in clinical research field (CRO or pharma)
- Root Cause Analysis investigation experience, including use of performance improvement tools required
- Knowledge of GxP compliance
- Experience working in global environment
Education:
- Bachelor's degree or relevant experience required
- Master's degree preferred
- RCA or Quality Management certification preferred
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com.
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