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

MSD•Rahway, PA

5d•Hybrid

About The Position

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. As a Digital Product Manager for Deviations & Issue Management QMS processes, you will lead cross-functional & cross-divisional teams, partner closely with site/manufacturing/technical operations subject-matter experts, and deliver large-scale system implementations that simplify the QMS technology stack, improve user experience, reduce costs, and enable data-driven decision making. This role is specific to Digitization of Deviations Management & Issue Management QMS Processes reporting to the Investigation Product Owner. Issue Management oversees a structured QMS process for identifying, documenting, assessing, investigating, containing, resolving, and preventing events affecting study integrity, product quality, participant/animal safety or regulatory compliance across GLP, GCP (including supplier quality and temperature excursions), Animal Welfare, and GRACS. Digital solutions support 1000+ users across GLP QA, GCP, Animal Welfare, GRACS and related functions within our research & development division. Deviation Management oversees the structured QMS process for recording, assessing, investigating and resolving GMP deviations across our manufacturing division and our research & development networks (internal/external networks, global distribution quality and third-party partners) covering end-to-end supply chains for clinical and commercial products. Digital solutions support 6000+ users across our research & development and our manufacturing divisions.

Requirements

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.
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

Nice To Haves

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.

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.