Associate Director Business Engagement

Johnson & Johnson•Horsham, PA

3d•Remote

About The Position

Johnson & Johnson is recruiting an Associate Director Business Engagement to build and maintain relationships with business partners across the supply chain and ERC areas. The role gathers stakeholder feedback and business insights about products, technology, GxP services, acquisitions, and divestitures, then uses those insights and regulatory requirements to develop fit-for-purpose audit strategies and keep the ERC (JJIA) audit programs current. It also drives continuous improvement of the audit program and auditor strategies, and supports standardized, risk-based audit preparation and scheduling to provide a holistic view of potential compliance risks across the supply chain. The position leads digital enablement of the ERC (JJIA) audit program, including developing and maintaining analytics and visualization solutions that provide near-real-time performance insights. It manages enterprise audit system records and annual audit schedules, advances automation and standardization across the audit lifecycle, and serves as a subject matter expert and system champion for next-generation quality platforms, supporting testing, user enablement, and cross-functional adoption. The position can be performed at any US or EMEA Johnson & Johnson location and may require up to 20% domestic and international travel.

Requirements

Bachelor’s degree (BS/BA) or equivalent four-year degree.
At least 8 years of experience in a QA and Regulatory Compliance role in the pharmaceutical, medical device, and/or OTC drug industry.
Strong quality and compliance background and deep understanding of global cGMP requirements and the systems used to deploy them.
Strong understanding and experience with process remediation.
Strong understanding of product and process development principles, including regulatory filing and approval processes across business segments, product types, and regions.
Experience performing GxP audits, including risk-based audit strategy development, audit planning, conducting audits, and concise reporting of audit outcomes.
Strong problem-solving, negotiation, influencing, and relationship-development skills.
Excellent written and oral communication skills and financial acumen.
Strong decision-making, analytical, and interpersonal skills, including the ability to communicate with individuals and groups at all levels.
Demonstrated ability to use data analytics tools and platforms to develop compliance insights, real-time dashboards, and audit program performance metrics.
Demonstrated capability to drive digital process innovation and automation, including identification and adoption of AI tools in a compliance or audit context.
Ability to travel up to 20% domestically and internationally.

Nice To Haves

A degree focused in science, engineering, organizational management, or another related field.
Experience working in the medical device or pharmaceutical industry.
ISO Certified Lead Auditor or ASQ Certified Auditor.
Working knowledge of data analytics tools such as Spotfire.
Proficiency in data analytics and visualization tools such as ThoughtSpot, Spotfire, or similar platforms.
Experience with AI-enabled tools such as Microsoft Copilot or CORA for audit intelligence, compliance data analysis, and automated reporting.

Responsibilities

Build effective relationships with key J&J supply-chain stakeholders and gather business insights to inform ERC (JJIA) audit strategies.
Engage business partners regarding products, technology, GxP services, acquisitions, and divestitures, and translate insights into audit program strategies.
Serve as primary liaison between the ERC audit team and Innovative Medicines quality and compliance stakeholders.
Develop and maintain the annual Innovative Medicines and External Manufacturer audit schedule, including creating and managing audit records.
Partner with Innovative Medicines EQ to support audit execution, remove barriers, and maintain alignment with enterprise audit commitments and governance standards.
Develop and continuously improve Pre-Audit Intelligence Packages using enterprise quality system data and AI-enabled tools.
Execute risk profiles for internal and external sites, conduct quarterly audit data trend analyses, and report performance metrics for compliance reviews and stakeholder reporting.
Help formulate and implement ERC (JJIA) audit procedure improvements for auditors.
Monitor regulatory changes, assess proposed regulations, and communicate new requirements to the organization.
Provide regulatory compliance subject matter expertise for acquisition and divestiture due diligence, new product initiatives, and supplier/External Manufacturer audit refusal and risk assessment processes.
Complete Innovative Medicine Pharmacovigilance System Master File contributions for ERC audits as required, and support health authority and internal audits of the audit program as a subject matter expert.
Develop and maintain real-time reporting dashboards, support integration of audit management system data, and evaluate and implement AI solutions for compliance analysis, pre-audit intelligence, and audit performance visibility.
Identify and lead process automation opportunities to reduce manual effort and improve efficiency across the audit lifecycle.
Support next-generation quality-platform testing, user enablement, and cross-functional adoption.
Perform other work-related duties as assigned.

Benefits

Consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Vacation: 120 hours per calendar year.
Sick time: 40 hours per calendar year, with different allocations for employees residing in Colorado or Washington.
Holiday pay, including floating holidays: 13 days per calendar year.
Work, Personal and Family Time: up to 40 hours per calendar year.
Parental Leave: 480 hours within one year of the birth, adoption, or foster care of a child.
Bereavement Leave: up to 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
Caregiver Leave: 80 hours in a 52-week rolling period.
Volunteer Leave: 32 hours per calendar year.
Military Spouse Time-Off: 80 hours per calendar year.