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Associate Director - Digital Solutions Quality Lead
- Franklin Lakes, New Jersey, United States
- Franklin Lakes, New Jersey, United States
Über
BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto look at the impossible and find transformative solutions that turn dreams into possibilities.
The Associate Director, Digital Solutions Quality Lead is a senior individual contributor within Technology & Global Services (TGS) accountable for defining and advancing the Quality function's digital, data, and AI strategy. Partnering closely with Quality leadership and process owners, this role shapes the future-state capability model and an outcome-based roadmap that improves Quality performance, strengthens compliance, and reduces operational risk.
Operating at the intersection of platform leadership, digital product strategy, and data/AI enablement, the role owns the end-to-end solution vision across core Quality platforms (e.g., eQMS) and Quality data and analytics. Success requires influencing cross-functional stakeholders and governance forums to prioritize investment and ensure solutions are scalable, interoperable, and inspection-readymeeting validation, data integrity, and auditability expectationswhile execution is delivered through aligned product, platform, and delivery teams.
Key Responsibilities
- Co-create in partnership with the function to the Quality digital, data, and AI strategy aligned to enterprise architecture, data strategy, and TGS priorities.
- Define the future-state capability model and an outcome-based roadmap (value, risk reduction, and compliance impact) with Quality process owners.
- Identify, prioritize, and scale high-value use cases across core Quality processes (e.g., field actions, complaints, nonconformances, CAPA, deviations, change control, audits, supplier quality, training, surveillance).
- Own the end-to-end solution vision across core Quality platforms and digital capabilities (e.g., eQMS; Quality data & analytics) to reinvent quality processes and shorten cycle time to compliant outcomes.
- Partner with the digital team and function to ensure context across the digital ecosystem to fully leverage and unlock the power of data assets.
- Provide platform and product direction (roadmaps, lifecycle/modernization, integration, data architecture, AI readiness) in partnership with Platform Solutions/Digital Transformation teams.
- Ensure solutions are scalable, interoperable, and audit-ready across product owners, architects, data teams, and vendors.
- Drive adoption of Quality data models, analytics, and insights to improve decision-making and outcomes.
- Champion advanced analytics and responsible AI (predictive, trend detection, decision intelligence) for regulated use cases and proactive insights to prevent compliance issues.
- Ensure AI/automation and digital solutions meet compliance expectations (validation, data integrity, auditability; GxP/21 CFR Part 11).
- Represent Quality priorities in governance (investment, portfolio, and architecture forums) and facilitate prioritization decisions (risk/value/compliance).
- Provide strategic oversight and value realization for initiatives (execution owned by delivery teams), including benefits tracking and continuous improvement.
- Support audits/inspections and continuously improve control/validation approaches to enable agile, data-driven delivery and manage risk in the use of AI/automation.
Required Qualifications
- Bachelor's degree or equivalent experience
- 8+ years leading digital and technology solutions in regulated Quality environments
- Demonstrated experience owning digital, data, or platform strategy (not just delivery)
- Strong understanding of Quality systems, Quality compliance expectations, and computerized system controls
- Experience enabling analytics, automation, or AI in regulated environments
- Proven ability to influence senior stakeholders without direct authority
- High proficiency in the practical use of AI and automation to drive value outcomes with examples of deployment at scale
Preferred Qualifications
- Experience with Quality platforms such as Trackwise, MasterControl, and other eQMS solutions, and analytics platforms
- Experience working with enterprise data platforms, integrations, and reporting tools (e.g., SAP, Power BI, Databricks, integration platforms)
- Familiarity with product-based delivery models, Agile/Hybrid delivery, and platform operating models
- Experience shaping AI governance, validation approaches, and data integrity models
- Global, matrixed operating experience
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Pay Transparency Statement:
At BD, we are committed to supporting our associates' well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role:
Annual Bonus
Potential Discretionary LTI Bonus
Health and Well-being Benefits
Medical coverage
Health Savings Accounts
Flexible Spending Accounts
Dental coverage
Vision coverage
Hospital Care Insurance
Critical Illness Insurance
Accidental Injury Insurance
Life and AD&D insurance
Short-term disability coverage
Long-term disability insurance
Long-term care with life insurance
Other Well-being Resources
Anxiety management program
Wellness incentives
Sleep improvement program
Diabetes management program
Virtual physical therapy
Emotional/mental health support programs
Weight management programs
Gastrointestinal health program
Substance use management program
Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit
Retirement and Financial Well-being
BD 401(k) Plan
BD Deferred Compensation and Restoration Plan
529 College Savings Plan
Financial counseling
Baxter Credit Union (BCU)
Daily Pay
College financial aid and application guidance
Life Balance Programs
Paid time off (PTO), including all required State leaves
Educational assistance/tuition reimbursement
MetLife Legal Plan
Group auto and home insurance
Pet insurance
Commuter benefits
Discounts on products and services
Academic Achievement Scholarship
Service Recognition Awards
Employer matching donation
Workplace accommodations
Other Life Balance Programs
Adoption assistance
Backup day care and eldercare
Support for neurodivergent adults, children, and caregivers
Caregiving assistance for elderly and special needs individuals
Employee Assistance Program (EAP)
Paid Parental Leave
Support for fertility, birthing, postpartum, and age-related hormonal changes
Leave Programs
Bereavement leaves
Military leave
Personal leave
Family and Medical Leave (FML)
Jury and Witness Duty Leave
To find purpose in the possibilities, we need people who can see the bigger picture,
Sprachkenntnisse
- English
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