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 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 compliance 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:
Relevant work 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
The Company
Our Company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been established in Zurich, aimed at accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our mission to save and improve lives around the world.
We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us.
Our Werthenstein BioPharma site in Schachen is where we conduct cutting-edge research, develop and analyze new biological agents, produce new products and supply clinical trial products for global clinical studies. The site is also home to one of our global forensic laboratories where we carefully monitor our products through the supply chain to ensure security and safety for our patients.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status: Regular
Relocation: No relocation
VISA Sponsorship: No
Travel Requirements: 10%
Flexible Work Arrangements: Hybrid
Shift: Not Indicated
Valid Driving License: No
Hazardous Material(s): N/A
Job Posting End Date: 04/15/2025
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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