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Job Details


Merck & Co, Inc

Associate Director, Clinical Supplies Quality (Hybrid)

Science and Research

Clinical Research Director

No

West Point, Pennsylvania, United States

Job Description

Position Overview

The Associate Director, Clinical Supplies Quality, Global Development Quality is responsible for disposition and support of Clinical Supply Chain for clinical development programs for our company's portfolio, specifically in terms of assuring the reliable availability, quality and regulatory compliance of clinical supplies produced. This position will have responsibility for support of US external quality operations and disposition, global distribution planning and management, and acquisition integration.

Primary Activities

This position will require an in-depth close collaboration with the key stakeholder groups including Global Clinical Supplies, Global Development Quality, Regulatory Affairs, and Global Clinical Trial Operations as well as multiple Quality Assurance sites and functions within 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.

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

  • Provision of in-depth technical and quality expertise regarding clinical supply operations and integration, Medical Device/Combination Products, and new technologies.

  • Development and execution of Quality and key stakeholder strategies, improvement initiatives in line with business drivers and objectives whilst streamlining processes and procedures and leveraging technology.

  • Evaluation and disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable policies/procedures of our Company and compliance with all governing regulations.

  • Coordination and/or support the investigation of deviations and significant quality events.

  • Identification of trends and/or potential compliance gaps and proactively leading the resolution of significant issues affecting quality and ensuring reliable clinical supply chain.

Required Skills:

Primary skills include but are not limited to:

  • Strong technical expertise in R&D activities specifically related to clinical supplies; experience in Medical Device/Combination Products and New Technologies is preferred

  • Strong compliance knowledge and understanding of regulatory agency regulations and requirements including proficiency in interpreting and applying cGMPs to R&D environment

  • Demonstrated experience working with external parties and stakeholders; ability to interact with and influence stakeholder subject matter experts and senior leaders

  • Demonstrated knowledge of continuous improvement methodologies; ability to manage complex cross-functional initiatives

  • Demonstrated leadership, including strategy development / deployment and experience with tangible delivered benefits.

Required Education/Experience:

  • Bachelor’s Degree in Scientific Discipline with 8+ years relevant experience within the pharmaceutical industry or Good Manufacturing Practice (GMP) related field (including Technical, Engineering, Quality or Operations) or advanced Degree with 6+ years relevant experience.

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 separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

EBRGS

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#Eligible for ERP

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:

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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:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Requisition ID:R269552