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

Merck; Rahway (NJ); Hybrid; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Paid Holidays

Vacation

Sick Days

Job summary

Merck is seeking a senior Digital Delivery Lead to steer Deviations QMS digitization within the QMS. You will migrate processes from Appian, UiPath, and SAP to Veeva Vault QMS, while defining the product vision and roadmap for Deviations digital capabilities.

Collaborate with SMEs to translate strategy into prioritized IT initiatives and own requirements for GxP systems. You will lead cross‑functional teams, drive end‑to‑end cloud platform deliveries, ensure SDLC and GxP compliance, and champion

Qualifications

• Bachelor’s degree in a scientific/technical field.
• 10+ years pharma experience in cross‑divisional initiatives.
• Experience leading large cloud deployments in regulated environments.
• Defined and prioritized product backlogs with development teams.
• Led cross‑functional teams in matrix organizations.
• Hands-on Deviations/Issue Management and QMS systems.
• SDLC and regulatory compliance knowledge (21 CFR 210/211, ICH, FDA).
• Strong communication to senior leadership and global stakeholders.

Responsibilities

• Lead digital delivery for Deviations QMS in Veeva Vault QMS.
• Migrate Deviations QMS from Appian/UiPath/SAP to Veeva Vault.
• Define product vision, roadmap, and priorities for Deviations.”
• Collaborate with SMEs and product owner to translate strategy.
• Own requirements and documentation for GxP systems.
• Drive end-to-end delivery of global cloud platform implementations.
• Ensure SDLC and GxP compliance in design, dev, testing, operation.
• Promote use of JIRA/Confluence; manage releases.
• Govern global process design for Deviations digital solutions.
• Partner with leaders to align investments and portfolio.
• Monitor performance; develop metrics; optimize TCO.
• Lead AI/ML capabilities for Deviations processes.
• Liaise between tech partners, vendors, and stakeholders.
• Advocate for user-centered design and direct user connection.
• Act as change agent to manage priorities and adoption.

Skills

Product Management

Backlog Management

Product Roadmap

Stakeholder Relationship Management

Strategic Planning

Requirements Management

GxP Compliance

SDLC

Change Management

Education

Bachelor’s degree in CS/Engineering/Biology/Chemistry

MS or MBA (preferred)

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

• 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 {+ 3 more}

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.

Requirements

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:
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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

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.

Bonus & Incentives

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

Benefits

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

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

• 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

R414582