Associate Director, Clinical Supply Quality Management Systems (QMS)

Job Description

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

The Compliance and Quality Management Systems (CQMS) organization is part of the larger Global Development Quality (GDQ) organization within our Research & Development Division Quality Assurance and is accountable for the execution of critical activities in the areas of compliance, quality systems, regulatory intelligence, and the Quality Management System (QMS).

This position reports to the Clinical Supply Quality Management System (QMS) Head, Global Development Quality and is the Clinical Supply Continuum Owner of QMS Chapter 5 (defined below) playing a key role in the design, implementation, and long-term maintenance of a new QMS, including Quality Standards and Global Standard Operating Procedures, for all Clinical Supply sites performing Clinical Supply functions within our Company's Global network.

The responsibilities of this position include, but are not limited to, the following:

Act as a cross-functional leader and Clinical Supply subject matter expert to hold the overall responsibility for the following QMS associated topics:

• Technology Transfer and Commercialization -

• Technology Transfer

• Validation

• Expiration, Retest Dating and Stability

• Shipping Qualification

• Pre-approval/Pre-license Inspection Readiness

• Health Authority Reporting

• Product Discontinuation

• Own the development, implementation, and ongoing maintenance of a new Clinical Supply Continuum for the above-mentioned QMS Chapter and subtopics that is based on regulatory requirements while allowing the greatest flexibility to allow for a rapid, effective, and compliant pharmaceutical development process and ensuring phase appropriate needs are considered to minimize unneeded requirements especially during early development manufacturing.

• Act as a change agent to stimulate, facilitate and coordinate the adaptation of the QMS redesign contributing to the overall the transformation of our Company's business and culture.

• Accountable for identification of Clinical Supply specific requirements for responsible areas and implementation at all sites with Clinical Supply functions.

• Liaise with and leverage the expertise of commercial regulatory intelligence personnel and chapter owners, the Clinical Supply Regulatory Intelligence Lead as well as external bodies to set direction for GMP requirements for Clinical Supply areas and ensure current regulatory requirements are met using, as well as developing, industry best practices.

• Significantly harmonize diverse Clinical Supply site practices by developing efficient, yet flexible Global SOPs and effectively implement at all sites with Clinical Supply functions.

• Identify areas of continuous improvement for simple lean quality system deployment, linked to our Company's Production System, ensuring best practice sharing while driving improvement within the Clinical Supply GMP network.

• Assist in QMS project planning activities, and other projects as assigned.

• May have oversight responsibilities for contingent workers supporting the QMS.

Education:

• B.S. / M.S. in an appropriate science, engineering, or business discipline.

Required Experience and Skills:

• Minimum of eight (8) years’ experience in the Pharmaceutical or equivalent industry with at least 4 years within the development space

• Strong technical knowledge, skills, and experience in R&D activities, coupled with the ability to interact with technical subject matter experts on the defined QMS Chapter / Subtopics above.

• Strong compliance mindset and knowledge of GMP regulations coupled with proficiency in interpreting and applying GMPs to a R&D environment

• Flexibility to travel up to 10% both domestic and international

Preferred Experience and Skills:

• Experience directly related to Quality Assurance or Quality Control

• Significant experience directly related to the development of Quality Standards and core requirements for Market Supply and / or Clinical Supply

• Excellent verbal and written communication skills as well as presentation skills

• Strongly developed cross-functional teamwork, collaboration, influencing and negotiating skills within and across divisions as well as within matrix organizations

• Multiple connections within industry to keep abreast of current regulatory trends.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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.

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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Residents of Colorado

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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.

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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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Under New York City, Washington State and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range:

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R227727