Associate Director Business Engagement

Johnson & Johnson Innovative Medicine•Horsham, PA

4d•$127,000 - $218,500•Remote

About The Position

Johnson & Johnson is hiring an Associate Director Business Engagement to build and maintain relationships with business partners and gather insights across the supply chain and ERC areas. The role translates stakeholder feedback and information about products, technology, GxP services, acquisitions, and divestitures into risk-based audit strategies, helping ensure the ERC (JJIA) audit program remains current and fit for purpose. The position serves as the primary liaison between the ERC audit team and Innovative Medicines quality and compliance stakeholders. The role leads development and maintenance of the annual Innovative Medicines and External Manufacturer audit schedule, manages audit records, and partners with Innovative Medicines EQ to support audit execution and governance. It develops pre-audit intelligence packages, site risk profiles, audit data trend analyses, and performance reporting. The position also supports audit procedure improvements, regulatory monitoring, compliance expertise for due diligence and other business activities, and audits of the audit program. The Associate Director drives digital enablement and analytics for the audit program, including dashboards, integration of audit management data, AI-enabled compliance analysis, and automation across the audit lifecycle. The role serves as a subject matter expert and system champion for next-generation quality platforms, supporting testing, user enablement, and cross-functional adoption. The position may require up to 20% domestic and international travel.

Requirements

Bachelor’s degree (BS/BA) or equivalent four-year degree; a degree in science, engineering, organizational management, or a related field is preferred.
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 developing risk-based audit strategies, planning and conducting audits, and concisely reporting outcomes.
Strong problem-solving, negotiating, influencing, and relationship-development skills.
Excellent written and oral communication skills and financial acumen.
Strong decision-making and analytical skills 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 ability to drive digital process innovation and automation, including identifying and adopting AI tools in a compliance or audit context.
Ability to travel up to 20% domestically and internationally.

Nice To Haves

Experience working in the medical device or pharmaceutical industry.
ISO Certified Lead Auditor or ASQ Certified Auditor certification.
Working knowledge of data analytics tools such as Spotfire.
Proficiency with 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 and maintain relationships with key J&J supply-chain stakeholders and gather insights to inform ERC (JJIA) audit strategies.
Engage business partners to collect information on products, technology, GxP services, acquisitions, and divestitures, and translate it into actionable audit program strategies.
Serve as the 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 and manage audit records.
Partner with Innovative Medicines EQ to support audit execution, remove barriers, and maintain alignment with enterprise audit commitments and governance standards.
Design and continually improve Pre-Audit Intelligence Packages using data from enterprise quality systems 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 improvements to ERC (JJIA) audit procedures.
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, supplier and external manufacturer audit refusals and risk assessments, and health authority or internal audits of the audit program.
Complete Innovative Medicine Pharmacovigilance System Master File contributions for ERC audits as required.
Develop and maintain audit-program dashboards, support audit management system data integration, and evaluate and implement AI solutions for compliance analysis, pre-audit intelligence, and performance visibility.
Identify and lead process automation opportunities across the end-to-end audit lifecycle.
Serve as a subject matter expert and system champion for next-generation quality platforms, supporting testing, user enablement, and cross-functional adoption.
Perform other work-related duties as assigned.

Benefits

Company consolidated retirement plan (pension) and 401(k) savings plan, subject to plan terms.
Vacation: 120 hours per calendar year, subject to policy and date of hire.
Sick time: 40 hours per calendar year; 48 hours for Colorado residents and 56 hours for Washington residents, subject to policy and date of hire.
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 a child’s birth, adoption, or foster care placement.
Bereavement leave: 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.