Job Description

The QMS Senior Specialist is responsible for providing leadership and direction for the execution of processes and procedures in support of the global QMS controlled documentation and systems. This position provides hands-on support for the Global Quality Management Systems (QMS) and Site/Function Standard Operation Procedure (SOP) Management within our Company Manufacturing Division.

This position is critical in our Company’s effort to create a simplified, integrated, user-centric global Quality Management System (QMS) for our human health products, with an objective to enable consistently compliant product quality, continuous improvement, and effective life-cycle management.

Primary Activities include, but are not limited to:

• Leads and/or supports cross-functional sub-teams supporting the QMS. Develops and executes sub-team project plans to ensure objectives are achieved and solutions meet desired target conditions.
• Manage QMS portfolio work plan via "QMS Tracker" tool.
• Collaborates and supports QMS workstreams in the development and management of their respective QMS documents in Quality Docs.
• Partners with customers, key stakeholders, and management to identify risks, resolve/mitigate, escalate/communicate to adequate management of any issues or delays to timelines for the respective project (s).
• Tracks & Measures metrics for the ongoing evaluation that processes & systems are working as intended, reviewed by the appropriate levels of management, and used as a basis for continual improvement.
• Using insights, experience, and judgment to proactively drive and improve global QMS related processes.

Minimum Education and Experience Required:

• Bachelor’s degree with five (5) years of project management and/or quality operation management experience (or equivalent) within a pharmaceutical, biopharmaceutical, medical device, or related industry.

Required Experience and Skills:

• Excellent facilitation, strong verbal, and written communication skills.
• Strong collaboration and cross-leadership skills to drive continuous improvement and promote knowledge sharing and endorsement of best practices.
• Capable of working and communicating effectively with all levels of a global organization.
• Proven ability to effectively initiate and drive change across a global organization.
• Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals & objectives.
• Successful experience in developing and executing project plans as well as the associated change management strategies.
• Participate in calls with project teams, drive completion of assigned activities, timely report-out on assigned actions and escalations of risks/issues to management.
• Proven ability to lead and implement multiple projects/tasks simultaneously with competing and/or changing priorities, effective time management.
• Proven ability to prioritize conflicting demands, apply a sense of urgency, when necessary, effective follow-ups on tasks and activities, and sees things to completion without letting things fall through the cracks.
• Demonstrated ability to make and act on decisions while balancing speed, quality, and risk.
• Successful experience in deploying global solutions to support the business.
• Knowledge of regulatory/industry requirements to work in a tightly regulated environment.
• Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.

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:

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EEOC GINA Supplement​

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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”.

Under New York State, Colorado State, 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:

$101,100.00 - $159,100.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed 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:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

06/15/2024

*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.

Job Posting End Date:06/15/2024

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:R297781