Job Description
The GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This includes defining and optimizing end-to-end processes and ensuring consistency and standardization across regions and functional areas.The role of the GPL involves developing and maintaining efficient, effective, and compliant business standards, process maps, and risk management for global processes across GRACS. The GPL actively engages with leadership across the GRACS organization and collaborates with internal and external functions such as our company's QA, GCD Standards, and Learning & Development. This collaboration is essential in developing and executing strategies that support the ongoing business needs of GRACS, including training process standards and strategies to ensure optimal quality and compliance in GRACS business processes.
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Core Responsibilities may include and are not limited to:
- Establish and maintain an engaged SME network as well as collaborative, and innovative culture in GRACS for business process management and continuous improvement.
- Establish and lead assigned domain Global Process Control Boards (GPCBs), accountable for successful design and performance of multiple global business processes ensuring alignment of global to local procedures.
- Collaborates with various SMEs, including leading cross-functional teams, to drive process improvements, streamline operations, and achieve business objectives on a global scale.
- Deep domain knowledge of the end-to-end process for their respective global business processes (e.g., enabling systems, upstream and downstream transfer of information and assets).
- Accountable for ensuring comprehensive and expert input into decisions/changes that affect business processes, roles and responsibilities, and role-based training associated with core business processes.
- Partner with Business System Owners on Alignment of Process & Technology.
- Develop &/or and manage process related artifacts (process maps, documentation, training content and role identification), ensuring alignment across impacted functional areas.
- Drive accountability for processes execution throughout GRACS through change management.
- Develop, implement and report process objectives and key performance indicators for assigned global process domains; Manage and report process performance against metric targets.
- Complete Impact assessment on new or changed external regulatory policies as it pertains to the processes that they own.
- Lead large-scale change initiatives across GRACS and engage across GRACS leadership to identify GRACS-level projects for continuous improvement of the organization, including managing the impact of final external regulatory policies that support work that is executed in GRACS.
- Ensure organizational compliance with global regulations including integration of Final Policy requirements into core business processes and procedures.
- Conduct process assessments, manage pre-requests, and participate in audits and inspections related to GRACS processes.
- Develop and improve upon business process management organization capabilities (e.g., lean six sigma, change management, executive-level facilitation, project management, negotiations, etc.).
- Ensure alignment with cross-functionally outside of GRACS and throughout the our company to develop and improve enterprise-wide process optimization.
- Represent our company, GRACS, BCST, Process Management, Metrics and/or Knowledge Management profession in forums outside the department, including participation on M&A or Business Development Execution, as well as engagements outside the company
Education:
- Bachelor's degree with 12+ years of industry experience, including regulatory and/or compliance area and experience with process management in a regulated environment.
- Master's Degree and a minimum of 8 years of industry experience including a regulatory and/or compliance area and experience with technical systems in a regulated environment.
Required Skills:
- Demonstrated success in both group-based and executive level facilitation
- Demonstrated success in leading strong, high performing teams
- Demonstrated success in change initiatives across a wide range of project sizes and endpoints including executive-level change initiatives.
- Advanced Training in Process Management Methodology (e.g., Sigma Greenbelt or higher)
- Broad organizational awareness; can work across multiple levels within an organization
- Demonstrated Change Management Knowledge and Application
- Project Management Skills
- Personnel Management/Coaching/Mentoring
- Excellent Communication Skills
Preferred:
- Advanced degree preferred (engineering or scientific discipline, MBA)
- Knowledge of GRACS organization, roles, and responsibilities.
- Demonstrated knowledge and success in portfolio management
- PMP Project Management Professional (PMP) or Certified Project Management (CPM)
- Six Sigma Master Blackbelt certification, or equivalent
- Change Management or Strategy Realization Framework Certification
NOTICEFORINTERNALAPPLICANTS
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.
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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.
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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, Monday - 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.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
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
Job Posting End Date:
01/4/2025
*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:R305899