Experience Inc. Jobs

Job Description

Position Overview & Responsibilities

Are you passionate about serving patients with quality products?

Within our Research & Development Division, the Global Clinical Supply (GCS) organization is accountable for the end-to-end supply chain (planning, sourcing, labeling, packaging and delivery of clinical supplies to clinical sites and patients) across the product portfolio to enable the execution of Phase I-IV clinical trials in 60+ countries in accordance with worldwide GxP regulations as set by the US cFR, EU eudralex, and all applicable jurisdictions as well as Sarbanes-Oxley (SOX) financial, and Environmental Health & Safety agency guidelines. GCS operates in close collaboration with Discovery Sciences Clinical Supply (DSCS), Global Development Quality, our Research & Development Division Quality, GCS, Global Clinical Trial Operations (GCTO), Preclinical Development Sciences and Clinical Supply (PSCS), Procurement, Subject Matter Experts (SMEs), Translational Medicine, IT (COMET) and our Research & Development Division (including our Research & Development Division Quality Assurance/QA and our Research & Development Division's IT) to serve our company's patients.

The GCS Senior Director of Compliance is a key accountable leader on the GCS Operational Excellence Leadership Team (LT) and the overall GCS extended leadership team (XLT) with the following responsibilities (including but not limited to):

• Design and lead the strategy implementation and execution of the culture of compliance across GCS and provide support to West Point, WAG, Rahway, Haarlem and external network to deploy our company's Compliance strategic goals and objectives aligned closely with business objectives.

• Develop a system for GCS Compliance processes and quality system process ownership and assure that clinical supply chain processes are followed, executed, and maintained in a compliant fashion.

• Deviations

• Corrective and preventive actions

• Change controls

• Audits and inspections

• Documentation administration and control

• Risk management

• Environmental Health and Safety

• Training including onboarding and upskilling

• Complaint management and stock recoveries

• Compliance aspects of integrations, acquisitions, merged assets etc.

• Accountable for success of audits and inspections and implementation of strategic responses that deliver results to action any potential areas for improvement identified in preparations or during audits and inspections, including on location support of Global audits and inspections.

• Develop and manage KPIs, assess trends, monitor, and lead monthly GCS Compliance forum as part of the Integrated Business Process to report output to stakeholders, driving improvement through targeted root cause analysis and action plans.

• Lead the Compliance Center of Excellence, which hosts Communities of Practice for Compliance areas of opportunity and upskilling, while developing and implementing processes and tools to ensure adherence to applicable company policies and quality management system (QMS) standards.

• Support the overall mission of the GCS Operational Excellence team to instill a continuous improvement culture collaborating with GCS management and staff, Research & Development Division Quality Assurance, Learning and Development, Clinical Quality and Improvement, Corporate Compliance and Supply Chain stakeholders globally.

• Lead team of GCS Compliance Professionals and functional service providers including talent attraction, development, and retention, team performance management, motivation, and engagement aligned to a resource model that meets the needs of the customer base in GCS and DSCS with attention to diversity, equity, and inclusion.

Qualifications

Education & Experience :

• Bachelor's degree with 15 years of clinical supply experience or MBA and 12 years of clinical supply experience.

• 5+ years people management experience.

Skill-based Qualifications :

• Ability to develop a strategic plan that influences the collective organization to execution excellence for delivery on customer needs and perspectives be it stakeholders or patients

• Process Design for compliance and quality system implementation and maintenance that drives and embodies ownership and accountability

• Operate with an entrepreneurial mindset staying current on pharmaceutical industry compliance trends and tools via networking and partnerships, conferences, etc

• Ability to deliver impact to the GCS Organization and our Research & Development Division by acting as a change catalyst

• Ability to drive team performance through talent growth, coaching and development, while fostering an environment of positivity, diversity, equity, and inclusion

• Excellent written and verbal communication skills with the ability to present complex information in a clear and concise manner to both technical and non-technical audiences

• Ability to properly identify risks to issue resolution, timelines, scope, or deliverables and escalate accordingly

• Strong compliance mindset and knowledge of GxP quality management.

#eligibleforERP

GCSCareer

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 (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.

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:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

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”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. 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 US salary range:

$164,800.00 - $259,400.00

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 (https://www.benefitsatmerck.com/) .

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:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

09/26/2024

*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: 09/26/2024

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: R312748