Job Description
Global Clinical Supply (GCS) organization is within our company's Research & Development (R&D) Division and is accountable for managing the 'end-to-end' integrated clinical supply chain across all R&D portfolio to enable the execution of any clinical trial using a company asset. GCS supports more than 300 Phase I-IV clinical trials run inhouse, 400+ outsourced or run by partners as well as our company's ISS clinical trials (300+). GCS is accountable for the planning, sourcing, labeling, packaging and delivery of clinical supplies to clinical sites across more than 60+countries, all in accordance with US and WW regulations, company policies and Standard operating procedures.
The Executive Director, Clinical Supply Operations is the US Head, a key part of GCS Leadership Team and is accountable for state of the art execution across all GCS facilities in the US. The role is accountable for Operations planning across the GCS work centers, will oversee all Packaging and Labelling operations in the region and will oversee all distribution from US to support all global clinical trials for R&D across all the modalities. The output of these facilities support a global portfolio across more than 60+ countries, ensuring exquisite delivery and performance and excellent quality and compliance of the company policies and standards, GCP, GMP and all country level regulations, to ensure the right clinical supplies are in the right place at the right time. The role will collaborate closely with the Europe Clinical Supply Operations head to ensure global standards and alignment.
In this role you will oversee and ensure appropriate processes and quality management across and within the different areas with exquisite partnership with Global Development Quality and other areas in QA, applying quality by design and appropriate risk management at all levels.
Primary activities include, but are not limited to:
Active member of GCS leadership team actively contributing to the strategy and global operations readiness
Talent attraction, development and retention
People Performance management
Represents GCS in external key conferences and working groups
Ensure exquisite operations across all GCS sites following global standards while ensuring we meet all unique countries needs in the clinical supply finished good regulations
West Point and Rahway end to end clinical supplies operations from Operations planning, packaging, labeling, warehouse and distribution across all product modalities
Manages & Leads the Clinical Supply Organization in the US
Represents the Global Clinical Supply group on Site/ Global Quality Compliance Councils.
Ensure an exquisite scheduling process and on time delivery of all work centers
Collaborates with external suppliers to support external operations.
Escalates any issues encountered and represents the group at the different governance committees.
Evaluates long-range capacity needs, and staff’s group as required to support the clinical packaging portfolio.
Assures cGMP, Environment, Health and Safety compliance for all processes and colleagues during the production operations.
Ensures regulations compliance in the writing / revising of procedures and SOP’s to ensure compliant operations.
Focus on continuous improvements to reduce cycle times and costs and improve reliability and flexibility.
Plans and implements site strategies for both the short-term maintenance and long-term acquisition of equipment. Supports the implementation of network-wide systems.
Provides input on operating budgets for labor, material, and capital expenditures.
Coaches, develops, and counsels colleagues on a timely basis regarding behaviors, skills, and career opportunities to form a high performance team.
Makes decisions on all operational issues related to the Operations Planning, Label Production, Packaging and Logistics work centers.
Partners with areas inside and outside of Operations on cross functional initiatives, as appropriate.
Line management of other line managers
5-6 direct reports (director level mainly) in different US locations
Organization size of approx. 150 people
Education:
Minimum Required Experience and Skills:
10 years experience in Clinical Supply Chain or Supply chain Operations, including exposure to Quality and or continuous improvement activities.
A minimum of 4 years of people management experience.
Any continuous improvement methodology will be an advantage
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
Pay Transparency Nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
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, generally Tuesday, Wednesday and either Monday or 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”.
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:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
N/A
