"Alerted.org

Job Description

Position Overview: Basic Functions & Responsibilities:

Reporting to the Executive Director, Clinical Supplies Quality (CSQ), the **Director, Clinical Supplies Quality – West Point** , leads the team responsible for operational management, capacity planning, scheduling, and execution of clinical supplies disposition activities supporting our company's clinical development programs. This role ensures the reliable availability, quality, and regulatory compliance of clinical supplies produced at West Point. The Director CSQ WP is a strong partner in cross-functional teams and drives operational excellence and continuous improvement with a strong focus on integration of digital solutions.

Primary Activities:

This position will require an in-depth close collaboration with the key stakeholder groups as well as multiple Global Development Quality sites and functions that support the clinical supply chain. This position will also include navigating dynamic, high impact and high visibility situations on a regular basis in relation to ensuring that our company's clinical development portfolio/pipeline is not disrupted due to issues with clinical supplies. Dimensions of the role include operational management for clinical supplies disposition/issue resolution activities for over 300 active clinical protocols, supporting >10,000 clinical sites in approximately 70 countries.

In addition to the high-level responsibilities discussed above, the incumbent is expected to independently execute on the following:

+ Lead, mentor and develop assigned staff, including resourcing, training and performance management.

+ Ensure reliability of clinical supplies availability for our company's clinical trials via daily operational management for the clinical finished goods disposition and supporting activities, with the associated potential for high impact to the development portfolio.

+ Oversee and manage capacity planning, scheduling and operational processes and systems are managed and enhanced for clinical supplies disposition and associated activities.

+ Develop and execute quality strategies, improvement initiatives in line with business drivers and objectives to ensure and enhance the robustness of our compliance posture whilst streamlining processes and procedures.

+ Provision of in-depth technical/quality expertise including identification of trends and/or potential compliance gaps and proactively leading the resolution of significant issues affecting quality in areas of expertise

+ Provide expertise in developing strategies for inspection readiness including working with Regulatory with relevant submissions for new and on-going clinical trials

+ As part of the Clinical Supplies Quality Leadership Team, create strategic plans and ensure translation of these in terms of related work processes and practices.

Education Requirements:

+ Bachelor’s Degree in Scientific Discipline with 10+ years relevant experience within the pharmaceutical industry or Master’s Degree with 7+ years relevant experience.

Required Experience and Skills:

+ Experience interacting with regulatory officials and external auditing parties.

+ A minimum of 4 years people management or leadership experience.

+ Lean Six Sigma certification (Green Belt or higher) preferred.

+ In-depth quality and compliance knowledge and understanding of regulatory agency regulations and requirements including proficiency in interpreting and applying cGMPs to R&D environment

+ Strong technical expertise in release activities specifically, ideally for clinical supplies, coupled with the ability to interact with and influence stakeholder subject matter experts and senior leaders

+ Operational management experience, including capacity planning and scheduling

+ Strong problem-solving and decision-making skills with an ability to determine interrogate the scientific data, identify true requirements, and drive right-first-time execution and accelerating batch release.

+ Experienced and strong people manager with proven track record of build, lead, and inspire effective teams navigate through business transformation

+ A strong transformation leader with a proven track record of leading continuous improvement and complex, cross-functional initiatives.

+ Demonstrated leadership including strategy development and deployment experience with tangible delivered benefits

Required Skills:

Auditing, Auditing, Batch Releases, Change Management, Client Relationship Building, Clinical Development, Clinical Protocol, Clinical Trials, Clinical Trials Operations, Creativity, Cross-Cultural Awareness, Cross-Functional Teamwork, Diversity Programs, Inspection Readiness, Leadership, Lean Six Sigma (LSS), Management Process, Mentoring Staff, People Leadership, Pharmaceutical Guidelines, Pharmaceutical Quality Assurance, Pharmacovigilance, Policy Implementation, Process Improvements, Process Streamlining {+ 5 more}

Preferred Skills:

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

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 salary range for this role is

$169,700.00 - $267,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

**San 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

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:

25%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

No

Job Posting End Date:

11/4/2025

*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.

**Requisition ID:** R371181