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Job Description
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 realted 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.
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
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
Current Contingent Workers apply
US and Puerto Rico Residents Only:
if you need an accommodation during the application or hiring process.
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected US salary range:
$101,100.00 - $159,100.00San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
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