At a Glance
- Tasks: Build relationships and enhance audit strategies in a dynamic healthcare environment.
- Company: Join Johnson & Johnson, a leader in healthcare innovation.
- Benefits: Inclusive culture, competitive salary, and opportunities for growth.
- Other info: Flexible location across multiple countries with travel opportunities.
- Why this job: Make a real impact on health solutions while driving digital innovation.
- Qualifications: 8+ years in QA & Regulatory Compliance; strong analytical skills.
The predicted salary is between 75600 - 92400 £ per year.
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.
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: High Wycombe, Buckinghamshire, United Kingdom
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:
- 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. Serves as primary liaison between the ERC audit team and Innovative Medicines quality and compliance stakeholders.
- 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.
- 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.
- Assists in formulating & implementing ERC (JJIA) audit procedure improvements to be followed by the ERC (JJIA) auditors.
- 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.
- 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.
- 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.
Johnson & Johnson is an Equal Opportunity Employer. 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 Rehabilitation 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.
Associate Director Business Engagement in High Wycombe employer: Johnson & Johnson
At Johnson & Johnson, we pride ourselves on being an exceptional employer, fostering a culture of inclusivity and respect for diversity. Our Leeds location offers employees the opportunity to work at the forefront of healthcare innovation, with access to comprehensive training and development programmes that support personal and professional growth. Join us to be part of a team that is dedicated to making a profound impact on health for humanity while enjoying a collaborative and supportive work environment.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director Business Engagement in High Wycombe
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Johnson & Johnson. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Johnson & Johnson.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Johnson & Johnson. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Johnson & Johnson is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Associate Director Business Engagement in High Wycombe
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Johnson & Johnson!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Johnson & Johnson that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Johnson & Johnson!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Johnson & Johnson, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Johnson & Johnson
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Johnson & Johnson that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Johnson & Johnson’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
