Clinical Quality Manager - France (Home-based) - FSP

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.

Parexel is currently seeking a Clinical Quality Manager (CQM) to join us in France, dedicated to a single sponsor.

Working at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work.

Expect exciting professional challenges in inspiring studies, but with time for your outside life.

Responsibilities

Audits & Inspections:

• Primary point of contact for Quality Assurance and Regulatory Agencies.

• Manage and support activities during audit/inspections.

• Perform, facilitate and manage  root-cause-analysis, Corrective and Preventive Actions (CAPAs) as well as responses to audit/inspection findings / reports. 

• On a regular basis look into local trends, facilitate root-cause-analysis (if necessary) and coordinate the development of local action plans.

Processes & Regulations:

• Local expert for ICH-GCP, local regulations and any quality-related process.

• Manage the local SOP/SME network to ensure a proper implementation of global/regional/local procedures and the regular update of local SOPs.

• Identify process improvement opportunities and properly escalate to the CQM Lead and/or Process Owner (if necessary).

• Lead or Co-Lead global/regional /local key initiatives/projects/process improvement activities upon request.

Training:

• Local training point of contact and the liaison between local Learning & Development.
  In close cooperation with country operations management, identify local training needs and coordinate related activities.

• Deliver quality topics (as needed).

Quality Control (QC) Activities:

• Coordinate and oversee proper execution of all QC activities at country/cluster i.e. In-house Quality Control Plan (IHQCP), Quality Control Visits (QCVs), etc.

• Perform QC activities and site visits (when required).

• Look into local trends, perform a root-cause-analysis (if necessary) and develop a local action plan.

Quality / Compliance / Privacy Issue Escalation:

• Communicate/escalate quality/compliance issues (incl. any potential trends) to local
  country operations management or CQM Lead as required.

• Escalate significant quality/compliance issues and supports investigations (fact finding,
  root-cause-analysis). Support the reporting of ‘Serious Breaches’ where applicable.

• Serve as local POC or supports local POC in case of escalations/reporting of Privacy
  Incidents, if applicable.

Clinical Supplies GCP Investigations:

• Evaluate trends and coordinate GCP Investigations of trends related to Clinical Supply GCP Inquiries and incorrect management of clinical supplies.

Supplier Qualification/Audits and supplier oversight:

• Lead/ support as applicable Local Supplier qualifications and supports solving of quality issues with locally selected Suppliers.

• Upon request, support the Quality Management System (QMS) assessment of global Suppliers or conduct/support regional supplier qualifications.

• Support as applicable Local Supplier Oversight.

• Coordinate or supervise the local vendor privacy assessments (SPA, IRA, ITRMS).

Here are a few requirements specific to this advertised role.

• Bachelor's Degree or equivalent in relevant health care area.

• Relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments.

• Deep knowledge and understanding of Clinical Trial processes as well as quality management and control tools is required.

• Demonstrated experience leading / participating in cross-functional teams.

• Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.

• Experience in quality management / compliance (e.g. audit/inspection support incl. CAPA management, SOP management, compliance issue management, training, etc.)

• Effective oral/written communication skills in an international environment including internal and external customers (e.g. Site staff, vendors, etc.)

• Project management and organizational skills; solid teamwork and leadership skills, including conflict resolution and discretion.

We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.

Who are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

You’ll be an influential member of the wider team.

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