Job Description

The Director, Business Systems Validation External / Automation provides strategic leadership and direction to validation teams within an assigned geography. They oversee performance management, organizational capability building and process optimization. They partner with other leaders on workforce strategy, talent development, and alignment on enterprise Business Validation goals.

Responsibilities:

Validation planning, strategy & readiness

• Define and lead validation strategy across domains and platforms, ensuring alignment with our company SDLC (Software Development Life Cycle) principles, data integrity, and enterprise quality management systems (QMS)

• Oversee validation risk management, ensuring balanced, risk-based approaches to coverage and compliance

• Work with leadership to set strategy for business system validation capabilities to be built

• Establish operational governance mechanisms to monitor validation readiness, cycle times, risks, and compliance across platforms and programs, escalating gaps to senior leadership as appropriate.

• Lead strategic alignment of validation processes with major platform roadmaps, data modernization initiatives, and cross-functional technical delivery plans.

Test execution, defect management & issue resolution

• Proactively identify systemic validation gaps, assess compliance risks, and drive corrective and preventive actions to improve validation quality, audit preparedness, and operational performance

• Drive functional-level operating model improvements based on learnings and findings

Documentation, compliance & continuous improvement

• Govern validation frameworks, policies, and methodologies to ensure consistent application and regulatory compliance across databases, automation tools, and study/standards and system platforms

• Establish and manage enterprise-level validation KPIs (Key Performance Indicators), scorecards, and governance dashboards

• Provide operational leadership and mentoring across validation teams, ensuring consistent execution of validation processes and technical capabilities

• Ensure alignment of validation activities with our Company's enterprise security, data protection, privacy, and QMS policies, partnering with relevant teams to ensure full policy adherence.

• Provide leadership during internal audits and external regulatory inspections by preparing evidence, responding to inquiries, and ensuring that validation documentation meets inspection-ready requirements.

• Ensure inspection readiness by overseeing validation documentation, audit responses, and evidence availability

• Represent validation in enterprise and Center of Excellence forums to drive harmonization of standards, templates, lifecycle documentation, and best practices across organizations.

• Oversee process documentation & completeness associated with archiving & decommissioning processes

People management:

• Align teams around a clear direction; set clear objectives aligned to organizational goals; assign work and set priorities accounting for work-life balance sustainability.

• Conduct regular check-ins and annual reviews; coach for performance; provide recognition.

• Develop career plans; create growth opportunities and promotion cases; ensure appropriate training and mentoring.

• Lead recruiting and hiring and oversee performance management activities, including management of sensitive employee-relations matters in partnership with HR.

• Coordinate on-shore/off-shore and contingent resources; ensure role clarity and effective handoffs.

• Manage an operating budget and optimize spend against priorities.

• Inspires and ensures that team leaders are effectively supporting and empowering their individual leaders.

Technical skills

• Advanced understanding of compliance and documentation standards (e.g., GxP, 21 CFR Part 11, and audit traceability practices)

• Deep experience in validation governance and enterprise risk management

• Strong understanding of data architecture, data lifecycle governance, and system interoperability

• Advanced knowledge of automation and AI testing frameworks, including validation of ML models and automated testing pipelines

• Proven experience overseeing audit readiness and regulatory inspections across global environments

Non-technical skills

• Excellent communicator with the ability to translate technical and operational priorities into clear, actionable direction

• Distills complex issues into decision-ready narratives; frames options, risks, and recommendations to influence senior decisions.

• Ability to define and execute organizational strategy for validation operations across regions

• Demonstrated success managing large, different, and geographically distributed teams

• Strong understanding of operational, financial, and compliance dimensions of global data delivery

• Capable of leading transformation initiatives and fostering innovation across complex organizations

• Leads through influence across functions/geographies; mentors global cohorts; provides structured feedback.

• Engages vendor, data, and industry forums; represents team professionally and credibly under pressure; maintains resilience and composure

• Strong understanding of operations of functions

• Enterprise Leadership Skills

• Strategic Planning | Plans strategically by gathering information and identifying key issues, dependencies, and relationships critical to achieving long-range goals; commits to a course of action after developing and evaluating alternatives based on facts, available resources, constraints, and organizational values.

• Networking & Partnerships | Cultivates networks and partnerships by initiating and maintaining strategic relationships with stakeholders and potential partners inside and outside the organization who provide the information, ideas, expertise, and influence needed to deepen understanding of business issues and achieve business goals.

• Change Catalyst | Leads change by driving the organizational and cultural shifts needed to achieve strategic priorities; catalyzes new approaches to improve results by evolving culture, systems, and services; helps others overcome resistance and adopt change.

Qualifications & experience:

• Bachelor's Degree in computer science, math or science with a minimum of 10 year's experience working in relevant field for associated job description (System Validation, Quality Assurance, Testing Lead or related technical role) as well as:

• 3 years people management experience.

• Demonstrated deep subject matter expertise in relevant discipline System Validation, Quality Assurance, Testing Lead or related technical role.

OR

• Advanced Degree (Masters or Doctorate) in computer science, math or science with a minimum of 8 years experience working in relevant field for associated job description (System Validation, Quality Assurance, Testing Lead or related technical role) as well as:

• 3 years people management experience.

• Demonstrated deep subject matter expertise in relevant discipline System Validation, Quality Assurance, Testing Lead or related technical role.

clinicaltrialjobs

EligibleforERP

#GDMS

Required Skills:

Automated Testing, Budget Management, Clinical Data Management, Data Integrity, Data Validation, Decision Making, Decommissioning, Good Clinical Practice (GCP), Key Performance Indicators (KPI), Mentoring Staff, People Leadership, Stakeholder Relationship Management, Strategic Thinking, System Validation, User Acceptance Testing (UAT)

Preferred Skills:

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.

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. 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

The salary range for this role is

$173,200.00 - $272,600.00

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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:

25%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

No

Job Posting End Date:

07/31/2026

*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.