Associate Director, Quality Enablement & Digital Solutions

Johnson & Johnson Innovative Medicine

Horsham (PA)

On-site

USD 137,000 - 236,000

Full time

27 hours ago

Be an early applicant

Application generator

Get a reply from this employer — a resume and cover letter tailored to exactly what they’re hiring for.

Get past ATS filters

Benefits offered by this job

Vacation–120 hours per calendar year

Parental Leave – 480 hours per year

401(k) retirement plan

Pension plan

Job summary

Johnson & Johnson Innovative Medicine is seeking an Associate Director, Quality Business Enablement to join our R&D Quality (RDQ) organization. You will partner with process owners to shape the quality solutions portfolio, lead delivery, and ensure sustainable, compliant digital solutions that improve operational effectiveness and inspection readiness.

Success requires 10+ years in regulated industries, strong leadership, deep GxP/GCP expertise, and experience in agile delivery, UAT oversight,

Qualifications

Minimum 10 years in pharmaceutical, biotechnology, or other regulated industries.
5+ years leading strategic initiatives, including execution, process improvement, and digital enablement.
Inspection and audit intelligence experience.
Proven track record influencing senior leadership and stakeholders through VP level and above.
Deep expertise in GxP/GCP requirements, GAMP 5, CSA/CSV, data integrity, audit trail, and 21 CFR Part 11 expectations.
Working understanding of traditional and modern digital capabilities as well as quality-related systems in a regulated environment
Demonstrated experience gathering business requirements from process owners and leading delivery of validated or compliance-sensitive solutions.
Experience in agile delivery, product or program governance, UAT oversight, adoption planning, and value realization.
Experience directing vendor or offshore delivery teams preferred.
Strong collaboration, alignment, change leadership, and influencing skills across a matrixed organization.
Travel up to 10% domestically and internationally.

Responsibilities

Partner with process owners and stakeholders to define quality solutions that support RDQ objectives.
Provide program governance for quality solution initiatives from scoping to adoption.
Influence prioritization and investment using value-based criteria.
Define business outcomes and ensure solutions deliver measurable value.
Champion inspection intelligence, audit analytics, automation, and AI-enabled capabilities.
Ensure solutions comply with GxP/GCP, validation, and governance requirements; maintain inspection-ready documentation.
Collaborate with Enterprise AI and Data Analytics teams to reuse enterprise platforms and standards.
Lead stakeholder engagement, training, and change management for sustainable adoption.
Oversee delivery resources and ensure quality and compliance in outputs.
Travel may be required up to 10%.