Job Description
The incumbent is responsible to support the operational functions of the Third Party Quality Management group, which provides quality oversight of suppliers and GMP service providers as well as contractors performing manufacturing, packaging, labeling, analytical testing, and distribution supporting the clinical supply chain on behalf of our company. Key activities this position would encompass:

• Support, maintenance, and continuously improving the Third Party Information Center (TPIC) and related dashboards
• Liaison between the development and business teams to ensure smooth communication and prioritization of work
• Interaction and collaboration with the Contractor Liaison function which supports strategic and operational initiatives for profiled and platform vendor base,
• Operational execution for phase appropriate, risk based processes for third parties' performance oversight and monitoring,
• Support the Contractor Liaison function through review and approval contractor related investigations, development of contractor profiles, and contractor CAPA management.

The position will be heavily involved in interacting with functional area stakeholders in all areas of development who utilize third parties to support GMP activities on strategic objectives utilizing external contractors. In addition to the job specific responsibilities discussed above, the incumbent is expected to independently execute on the following:

• Engages in strategic planning activities across the Quality Unit and participates in project planning and activities of self and team activities.
• Makes independent decisions and acts with authority to carry out required actions.
• Participates in the resolution of business practice, Quality and/ or compliance issues of broad scope and highest level of complexity on cross-functional and/ or cross-divisional basis.
• Identifies trends and/or potential compliance gaps and proactively leads the resolution of issues affecting quality and efficiency.
• Reviews draft policy and standards.
• Communicates with senior management within our company and the third-party organization as needed. Facilitates and/or prepares cross-functional management presentations.

Education Minimum Requirement:
At a minimum the position requires a bachelor's degree in engineering, IT, Biology, Chemistry or related field.
Required Experience and Skills:

• A minimum of 5+ years of relevant experience within the pharmaceutical industry
• Advanced Degree with 3+ years relevant experience.

Preferred Experience and Skills:

• 5 years experience with developing and administration of SharePoint Online features and O365 components (Power Apps, Power BI, MS Flow)
• Experience with Nintex Flows, Python, Spotfire and Microsoft 365
• Application of Artificial Intelligence and machine learning
• Experience in developing dashboards with metrics using Python and Spotfire technology in collaboration with data scientists and QA Analytics and Insights
• Data analysis experience
• Possess drug development knowledge; demonstrated ability to facilitate training and learning in colleagues and apply knowledge to enhance the drug development process.
• Demonstrated knowledge of continuous improvement methodologies; ability to lead matrix teams, recognize improvement opportunities, develop appropriate solutions and follow through on implementation
• Strongly developed cross-functional teamwork, collaboration, influencing and negotiation skills
• Demonstrated skills in communicating (oral and written) effectively with diverse individuals/ groups
• Demonstrated time management skills, ability to conduct well defined projects within discipline or area of expertise

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.
GRACSJOBS
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 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.
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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:
Yes
Hazardous Material(s):
N/A
Job Posting End Date:
06/17/2024
*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:06/17/2024
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:R295496