Digital Product Manager (Director) - Deviations & Issue Management QMS Processes

MSD Malaysia; West Point (PA); Hybrid; USD 173,000 - 273,000; Full time

Benefits offered by this job

Annual bonus

Long‑term incentive

Medical, dental, vision

Retirement benefits (401(k))

Paid holidays and vacation

Job summary

Merck & Co., Inc. seeks a Senior Digital Delivery Lead to drive Deviations QMS digitization within a global cloud platform. You will lead cross-functional teams, translate business strategies into IT initiatives, and ensure GxP and SDLC compliance across sites and regions.

You will partner with SMEs and the Investigations Product Owner to deliver prioritized backlogs, implement AI/ML capabilities, and optimize TCO while championing user-centered design.

Qualifications

• Bachelor's degree in a scientific/technical field required.
• 10+ years of pharma/regulatory experience in related roles.
• Experience leading cross-divisional process improvements and cloud rollouts.
• Proven backlog prioritization with development teams.
• Strong leadership across matrix, internal and external teams.

Responsibilities

• Lead digital delivery for Deviations/Issue Management in a QMS.
• Define product vision, roadmap, and prioritized backlog.
• Translate business strategy to IT initiatives with SMEs and PO.
• Ensure GxP and SDLC compliance in global cloud deployments.
• Drive relationships with leaders to align investments and portfolio.

Skills

Asset Management

Backlog Management

Backlog Prioritization

Product Management

Product Roadmap

Stakeholder Relationship Management

Strategic Planning

Strategic Thinking

Delivery Coordination

Influencing Without Authority

Organizational Change Management

Requirements Management

Process Alignment

Leadership

Regulatory Compliance

Education

Bachelor's degree in computer science, engineering, biology, chemistry, or a related scientific/technical field

Tools

JIRA

Confluence

Veeva Vault QMS

Trackwise

SAP ECC 6.0

Appian

SAP S4 Hana

Job description

Job Description

Join our manufacturing division Digital Quality Operations - Investigations Digital Product Group, to lead the digitization of Deviations QMS process within the Quality Management System (QMS). Our company is at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

Responsibilities

• Digital Delivery Lead for implementation of Deviations Management & Issue Management Process into Veeva QMS Vault.
• Scope - Migrating Deviations QMS Process and Data from Appian, UiPath Solutions & SAP ECC 6.0 to Veeva Vault QMS and integration to SAP S4 Hana.
• Define and lead the product vision, value map, and roadmap for Deviations digital capabilities.
• Partner with site/manufacturing/technical operations SMEs and the Investigations Product Owner to translate business strategy into prioritized IT/product initiatives.
• Own requirements definition, translation between business and development teams, and documentation for GxP systems.
• Lead continuous product discovery to surface user needs and convert findings into a prioritized product backlog.
• Drive end-to-end delivery of large global cloud platform implementations in the pharma/life sciences environment.
• Lead cross‑functional, matrixed teams, provide oversight to less senior team members, and be accountable for the release of products.
• Ensure IT systems are designed, developed, tested, and operated in SDLC- and GxP‑compliant manner.
• Champion the effective use of IT standards, tools (JIRA, Confluence), and release/support planning.
• Enable & govern consistent, global process design for Deviations digital solutions.
• Establish strong relationships with business and technology leaders to align investment and portfolio planning.
• Drive performance monitoring, metrics development, and optimize total cost of ownership (TCO).
• Lead design and delivery of AI/ML capabilities for Deviations processes.
• Serve as liaison between technology partners, vendors, and stakeholders.
• Advocate for user-centered design and facilitate direct connections between delivery squads and end users.
• Act as change agent: influence stakeholders, manage conflicting priorities, and support organizational adoption of new ways of working.

Qualifications

• Bachelor’s degree in computer science, engineering, biology, chemistry, or a related scientific/technical field.
• Minimum of ten (10) years’ experience in association to the listed required skills within the pharmaceutical industry.
• Proven experience leading cross‑divisional large & complex process improvement initiatives, system implementations, and cloud platform rollouts in regulated environments.
• Proven track record and experience of defining and prioritizing product backlogs and collaborating with development teams.
• Demonstrated leadership of cross‑functional teams (internal and external), with experience in matrix organizations.
• Hands‑on knowledge of Issue Management & Deviations processes and relevant QMS systems (Veeva Vault QMS, Trackwise, SAP, Appian).
• Experience developing, implementing, or managing Deviations Management - AI/ML /Gen AI solutions and partnering with data science teams to operationalize models.
• Strong working knowledge of SDLC practices for GxP systems, validation/testing, and regulatory compliance (21 CFR 210/211, ICH, FDA guidance).
• Exceptional verbal and written communication skills; ability to present complex technical and regulatory concepts to senior leadership and global stakeholders.
• Strong analytical and problem‑solving skills; data‑driven decision‑making mindset.
• Ability to influence without direct authority, manage change, and work effectively in ambiguous, fast‑moving environments.

Preferred

• Preferred Minimum of five (5) years working experience at GMP manufacturing sites, technical operations, or other site‑level roles with hands‑on exposure to Deviations processes.
• Five or more (5–10+) years preferred in roles focused on Deviations, Root Cause Investigations, quality/regulatory, and digital enablement.
• Experience and exposure to DS, DP, FDP End to End Manufacturing, Supply Chain & Logistics, QC Operations, GCP Operations.
• Prior experience with global releases and multi‑region deployments in pharma/life sciences.
• Advanced degree (MS or MBA) in scientific, engineering, or technical discipline.

Required Skills

• Asset Management
• Asset Management
• Backlog Management
• Backlog Prioritization
• Benefits Management
• Business Alignment
• Business Decisions
• Business Informatics
• Conceptual Thinking
• Delivery Coordination
• Influencing Skills
• Influencing Without Authority
• Management System Development
• Organizational Change Management
• Organizational Leadership
• Process Alignment
• Process Standardization
• Product Lining
• Product Management
• Product Management Strategy
• Product Roadmap
• Requirements Management
• Stakeholder Relationship Management
• Strategic Planning
• Strategic Thinking

Employment Details

• 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

Salary

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.

Benefits

• The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable.
• 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.

Job Posting End Date

Job Posting End Date: 09/15/2026 *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.

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

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.

About Us

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.

Application Deadline

The application deadline for this position is stated on this posting.