Associate Director Standards & Execution

MSD Malaysia; Northern (KY); Hybrid; USD 129,000 - 203,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits package

401(k) retirement plan

Paid holidays and vacation

Job summary

Merck & Co., Inc. seeks an Associate Director, Standards & Execution to lead planning, execution, and implementation of strategic initiatives for the Global Regulatory and Clinical Safety (GRACS) Quality Management System (QMS).

The role drives compliance programs including GRACS Privacy, Data Security, and Records Management in line with corporate policy and regulatory requirements. The position collaborates with GRACS and enterprise stakeholders to translate business needs into actionable

Qualifications

• Extensive experience in project management and regulatory/compliance domains.
• Bachelor’s Degree with substantial project management and regulatory exposure; advanced degrees valued.
• PM/PMO related certifications or equivalent experience appreciated.

Responsibilities

• Lead the planning, coordination, and successful execution of assigned strategic initiatives, ensuring alignment with program objectives, sponsor expectations, and organizational priorities.
• Partner with project leaders to develop and manage project plans, governance structures, implementation activities, milestones, risks, and deliverables.
• Establish and lead the GRACS records management and document retention program, including development of associated standards, governance, processes, tools, and controls.
• Support the execution of the GRACS Data Security Program (DSP), including monitoring, reporting, documentation, and governance activities, with particular focus on sensitive data transfers and related compliance requirements.
• Support the GRACS Privacy Program by collaborating with business process owners to develop, maintain, and periodically assess privacy impact assessments and related compliance documentation.
• Coordinate and support annual privacy assessments and associated remediation activities across GRACS.
• Partner with stakeholders to ensure appropriate third-party due diligence processes are completed, documented, monitored, and renewed for both global and U.S.-based vendors and service providers.
• Drive continuous improvement of governance, compliance, and operational processes through effective stakeholder engagement, risk identification, and implementation of sustainable solutions.
• Provide leadership communications, metrics, and status reporting to support informed decision-making and business performance transparency.
• Support the GRACS Privacy program including collaboration with process owners in the creation and maintenance of their respective privacy assessments.

Skills

Coordinate

Business Alignment

Business Decisions

Change Management

Compliance Requirements

Cross-Functional Teamwork

Document Control Systems

Leadership Reporting

Negotiation

Process Analytics

Project Leadership

Project Management

Project Planning

Regulatory Compliance

Regulatory Experience

Stakeholder Management

Strategic Thinking

Education

Bachelor’s Degree

Advanced degree

Job description

The Associate Director, Standards & Execution is responsible for leading the planning, execution, and implementation of strategic initiatives that support the Global Regulatory and Clinical Safety (GRACS) Quality Management System (QMS). This role provides leadership and execution for key compliance programs, including GRACS Privacy, Data Security, and Records Management, ensuring alignment with corporate policies, regulatory requirements, and organizational objectives. This role partners closely with stakeholders across GRACS and enterprise functions to assess business needs, define requirements, and develop execution strategies that strengthen compliance, enhance operational effectiveness, and promote transparency across a globally organization. The role requires proactive engagement with GRACS leadership and cross-functional collaboration with areas such as Information Technology, Finance, Procurement, Legal, Privacy, and Corporate Security.

Responsibilities

• Lead the planning, coordination, and successful execution of assigned strategic initiatives, ensuring alignment with program objectives, sponsor expectations, and organizational priorities.
• Partner with project leaders to develop and manage project plans, governance structures, implementation activities, milestones, risks, and deliverables.
• Establish and lead the GRACS records management and document retention program, including development of associated standards, governance, processes, tools, and controls.
• Support the execution of the GRACS Data Security Program (DSP), including monitoring, reporting, documentation, and governance activities, with particular focus on sensitive data transfers and related compliance requirements.
• Support the GRACS Privacy Program by collaborating with business process owners to develop, maintain, and periodically assess privacy impact assessments and related compliance documentation.
• Coordinate and support annual privacy assessments and associated remediation activities across GRACS.
• Partner with stakeholders to ensure appropriate third-party due diligence processes are completed, documented, monitored, and renewed for both global and U.S.-based vendors and service providers.
• Drive continuous improvement of governance, compliance, and operational processes through effective stakeholder engagement, risk identification, and implementation of sustainable solutions.
• Provide leadership communications, metrics, and status reporting to support informed decision-making and business performance transparency.
• Support the GRACS Privacy program including collaboration with process owners in the creation and maintenance of their respective privacy assessments.

Qualifications

Education Minimum Requirement: Minimum 15+ years’ experience in project management, systems management and/or regulatory related experience or Bachelor’s Degree with a minimum of 8 years of project management, systems management and/or regulatory related experience or an advanced degree and a minimum of 4 years of project management and/or regulatory related experience.

Required Experience and Skills: Excellent facilitation, complex project management, problem solving, and written and verbal communication skills, including presentations to senior management Demonstrated experience in compliance, governance, privacy, data security, records management, or quality management systems. Ability to translate business requirements into practical execution plans and measurable outcomes. Strong stakeholder management, influence, and communication skills across all organizational levels. Experience working in a global, highly regulated environment preferred. Proven ability to lead multiple priorities while driving execution and delivering results. Ability to lead by influence and work effectively in matrix organizational structures Process Management Knowledge (e.g., Green Belt) Good interpersonal and communication skills (in English, both verbal & written) Good negotiation skills with internal stakeholders Strong analytical skills with a demonstrated ability to extensively analyze business processes and workflows.

Preferred Experience and Skills: Demonstrated Change Management knowledge and experience in a wide range of projects Lean Six Sigma and Change Management Certification Demonstrated project management skill, knowledge, and application, including PMI/PMP Certification.

Required Skills: Ability to Coordinate, Business Alignment, Business Decisions, Change Management, Compliance Requirements, Cross-Functional Teamwork, Document Control Systems, Leadership Reporting, Negotiation, Process Analytics, Project Leadership, Project Management, Project Planning, Regulatory Compliance, Regulatory Experience, Stakeholder Management, Strategic Thinking.

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment.

The salary range for this role is $129,000.00 - $203,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

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: Not Indicated
• Valid Driving License: No
• Hazardous Material(s): n/a

Job Posting End Date: 09/14/2026

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.