Sr. Specialist, Global Clinical Supply Compliance (Hybrid)

Job Description

Are you passionate about serving patients with quality products? Within our Research and Development Division, the Global Clinical Supply (GCS) organization is accountable for the end-to-end supply chain (planning, sourcing, labeling, packaging and delivery of clinical supplies to clinical sites and patients) across the product portfolio to enable the execution of Phase I-IV clinical trials in 60+ countries in accordance with worldwide GxP regulations as set by the US cFR, EU eudralex, and all applicable jurisdictions as well as Sarbanes-Oxley (SOX) financial, and Environmental Health & Safety agency guidelines. GCS operates in close collaboration with Discovery Sciences Clinical Supply (DSCS), Global Development Quality, our Research and Development Division, Quality, GCS, Global Clinical Trial Operations (GCTO), Preclinical Development Sciences and Clinical Supply (PSCS), Procurement, Subject Matter Experts (SMEs), Translational Medicine, IT (COMET) and our Research and Development Division (including our Research and Development Division Quality Assurance/QA and our Research and Development Division's IT) to serve company patients.

The Sr. Specialist, Global Clinical Supply Compliance is a support role for the GCS functional business areas responsible for conducting activities to ensure the GCS Organization adheres to compliance standards set forth in the overarching Quality Management System (QMS). This role is critical in supporting a culture of compliance throughout the organization with the with the following responsibilities (including but not limited to):

• Conduct activities to support to West Point, WAG, Rahway, Haarlem and external network to meet the GCS strategic complaince goals and objectives aligned closely with business objectives.

Provide support and oversight for GCS compliance processes and assure that clinical supply chain processes are followed, executed, and maintained in a compliant fashion related to the following:

• Deviations

• Corrective and preventive actions

• Change controls

• Audits and inspections

• Documentation administration and control

• Risk management

• Environmental Health and Safety

• Training including onboarding and upskilling

• Complaint management and stock recoveries

• Compliance aspects of integrations, acquisitions, merged assets etc.

Qualifications

Education & Experience:

• Bachelor's degree with 2 years experience or Master degree with 1 year experience in a Scientific /Engineering or related fields.

Skill-based Qualifications:
With some oversight and coaching and the willingness and aptitude to develop:

• Learn and conduct activities that drive and embody ownership and accountability.

• Properly identify risks to issue resolution, timelines, scope, or deliverables and escalate accordingly

• Establish a good understanding of GxP and ALCOA+ principles

• Foster collaboration and drive results

• Develop strong, trust based, collaborative relationships with a diverse group of stakeholders

• Strategic thinking and independent decision-making

• Communicate clearly, effectively and tactfully

Preferred Experience and Skills:

Minimum of 1 year experience in supporting and/or managing:

• Deviations

• Corrective and preventive actions (CAPA)

• Change controls

• Audits and inspections

• Documentation administration and control

• Risk management

• Environmental Health and Safety

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