Associate Director Business Engagement

6010-Biosense Webster Inc. Legal Entity; Limerick; On-site; EUR 86,000 - 148,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being programs

Job summary

Johnson & Johnson is hiring for an Associate Director Business Engagement to build strategic relationships with business partners across the J&J supply chain and drive ERC (JJIA) audit programs. You will design audit strategies, develop pre-audit intelligence, and lead data-driven compliance initiatives.

Requires a Bachelor’s degree and at least 8 years in QA & Regulatory Compliance within pharma/medical devices, with strong knowledge of cGMP and regulatory filings across regions.

Qualifications

• Bachelor’s degree (BS/BA) or equivalent four-year degree.
• 8+ years in QA & Regulatory Compliance within Pharmaceutical/Medical Device/OTC industries.
• Strong understanding of global cGMP requirements and regulatory filing across regions.
• Experience in performing GxP audits and risk-based audit strategies.
• Ability to leverage data analytics tools for compliance insights.

Responsibilities

• Establish effective relationships with key stakeholders in the supply chain to define audit strategies.
• Lead development and maintenance of annual audit schedules and records.
• Design and improve Pre-Audit Intelligence Packages using enterprise quality systems and AI-enabled tools.
• Support procedure improvements and standardization across the audit lifecycle.
• Travel up to 20% domestically & internationally; engage in ongoing regulatory monitoring.

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): Belgium R-108507, Ireland R-108510, Netherlands R-108511, Switzerland R-108508, United Kingdom R-108509, United States of America R-107816 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Job Function: Legal & Compliance

Job Sub Function: Enterprise Compliance

Job Category: People Leader

All Job Posting Locations: Limerick, Ireland

Job Description:

Johnson & Johnson is currently recruiting for Associate Director Business Engagement! This position can be performed at any US or EMEA J&J location.

Position Summary:

The position builds and maintains mutually beneficial relationships with the J&J business partners – focusing on the segment of the business they are aligned to. Through proactive engagement across the supply chain and ERC areas, the position will actively collect stakeholder feedback and business insights to enhance ERC (JJIA) knowledge of existing and new products / technology / GxP services either currently in use or planned within the J&J. This strategic role ensures the ERC (JJIA) audit programs remain current. The position uses insights obtained along with relevant regulatory requirements to develop audit strategies based on a ‘fit for purpose’ mindset. This position also drives continuous improvement of the ERC (JJIA) audit program, including setting the ERC (JJIA) auditor strategies. The position will support standardization all ERC (JJIA) audit support activities, driving improved and economized audit preparation, including risk-based scheduling, resourcing, pre-audit planning based on site type, products, technology and potential linkages to other sites, regions and site types. Supporting to the objective of providing a holistic view of potential compliance risks across the J&J supply chain. The position additionally leads the digital enablement of the ERC (JJIA) audit program through design, development, and maintenance of data analytics and visualization solutions that deliver near-real-time audit program performance insights. The position manages enterprise audit system records, oversees the development and maintenance of annual audit schedules, and drives automation and process standardization across the end-to-end audit lifecycle. The role also serves as a subject matter expert and system champion for next-generation quality platforms, supporting system testing, user enablement, and cross-functional adoption.

Key Responsibilities:

• 25% Establish effective business relationships with key stakeholders within the J&J supply chain that will enable insights that are used to define ERC (JJIA) audit strategies. Proactively engages business partners to collect insights on products, technology, GxP services, acquisitions, and divestitures, and translates these insights into actionable audit program strategies.
• 20% Leads the development and ongoing maintenance of the annual Innovative Medicines and External Manufacturer (EM) audit schedule, including creation and management of audit records. Partners with Innovative Medicines EQ to drive audit execution, remove barriers, and maintain alignment with enterprise audit commitments and governance standards.
• 20% Leads the design, development, and continuous improvement of Pre-Audit Intelligence Packages, integrating data from enterprise quality systems and AI-enabled tools to generate actionable pre-audit intelligence. Executes ERC site risk profiles for Internal and External sites, conducts quarterly audit data trend analysis, and provides audit program performance metrics reporting in support of JJRC Compliance reviews and quarterly stakeholder reporting.
• 10% Assists in formulating & implementing ERC (JJIA) audit procedure improvements to be followed by the ERC (JJIA) auditors.
• 10% Maintains abreast of regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings. Assesses proposed regulations and communicates new requirements to the organization. Provides regulatory compliance subject matter expertise (SME) in support of acquisition and divestiture due diligence activities, new product initiatives, and supplier/EM audit refusal and risk assessment processes. Completes Innovative Medicine Pharmacovigilance System Master File (PSMF) contributions for ERC audits as required, and supports health authority and internal audits of the audit program as a SME.
• 10% Drives digital enablement and data analytics innovation across the ERC (JJIA) audit program by developing and maintaining real-time reporting dashboards, supporting integration of audit management system data, and evaluating and implementing artificial intelligence solutions to enhance compliance analysis, pre-audit intelligence, and audit program performance visibility. Identifies and leads process automation opportunities to reduce manual effort and increase efficiency across end-to-end audit lifecycle activities.
• 5% Other work-related duties as assigned.

Qualifications:

Education: A minimum of a Bachelor’s degree (BS/BA) or equivalent 4-year degree is required, preferably with a focused degree in science, engineering, organizational manager or other related field.

Required Skills, Knowledge & Capabilities:

• A minimum of 8 years of experience in a QA & Regulatory Compliance role within a Pharmaceutical, Medical Device and/or OTC Drug Industry environment.
• Strong Quality and Compliance background with a deep understanding of Global cGMP requirements and the systems used to deploy them.
• Strong understanding and experience with process remediation.
• Strong understanding of product / process development principles, including regulatory filing / approval processes across all segments of the business, product types and regions.
• Experience in performing GxP audits, including the development of risk-based audit strategies, audit planning, conducting audits and reporting audit outcomes in a concise manner.
• Strong problem-solving skills, negotiating skills, influencing skills, and developing relationships.
• Excellent written and oral communication & Financial acumen.
• Strong decision making and analysis skills and interpersonal skills, including ability to communicate with individuals and groups at all levels.
• Demonstrated ability to leverage data analytics tools and platforms to develop compliance insights, real-time reporting dashboards, and audit program performance metrics.
• Demonstrated capability to drive digital process innovation and automation, including the identification and adoption of artificial intelligence tools in a compliance or audit context.

Preferred Skills:

• Experience working in Medical Device / 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, and/or similar platforms; experience with AI-enabled tools (e.g., Microsoft Copilot, CORA) for audit intelligence, compliance data analysis, and automated reporting.

Other:

This position may require up to 20% domestic & international travel

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitati on Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs.

If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.

Required Skills: Preferred Skills:

The anticipated base pay range for this position is: €86,400.00 - €148,350.00 Benefits:

Benefits:

• an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
• Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health.
• We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans.
• For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
• *This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. Our Credo calls on us to respect the dignity of every individual and create an environment for all people to thrive.

Throughout the recruitment process - from application through hiring - we are committed to providing reasonable accommodations/adjustments for qualified candidates with disabilities.

If you need support at any stage of the recruitment process, please complete our candidate accommodation request form so we can assist you.

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