J&J Family of Companies QA Auditor in High Wycombe, Poland

Quality Assurance Auditor

Business Area: Janssen

Locations: High Wycombe, Italy, Beerse, Paris, Poland or USA

Who is Janssen? We’re more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. From heart disease to HIV, Alzheimer’s disease to cancer, we are committed to issues that touch everyone’s lives. Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it. So every day, in more than 150 countries, we bring cutting-edge science and the most creative minds in the industry together to think differently about diseases. We aim not only to innovate but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health.

We are looking at a future where the world of healthcare will be challenged by informed and empowered patients. We work for change that will improve access to medicines: the best available treatment at an affordable price. That’s why we at Janssen strive to provide access to effective and affordable medicines and related healthcare services to the people who need them.

We are recruiting a QA Auditor to come and work in the Infectious diseases and Vaccines area.

Position Summary

Independently leads the planning, conduct and reporting of BioResearch QA routine and non-routine audits/assessments and supports inspections of the J&J Pharmaceutical sector worldwide, including J&J Operating Companies (including Consumer for pharmacovigilance), partners and service providers. These audits/assessments/inspections provide an independent quality assessment to ensure compliance with appropriate regulations, SOPs, processes, etc. to ensure the quality of company-sponsored R&D and post-marketing pharmacovigilance activities within the assigned domain (Pre-clinical, Clinical, PV, or Multi-Discipline). Leads or contributes to other project initiatives within the organization. Serves as subject matter expert in one or more compliance disciplines or areas (e.g. GLP, GCP, PV, computerized systems, non-regulated area) and acts as a contact for internal and/or external stakeholders. Also actively involved in coaching and training other auditors.

Key Responsibilities

Auditing

Independently leads the planning, conduct and reporting of BioResearch QA routine and non-routine audits/assesments/inspections of activities, data, internal facilities and processes in GxP/non-regulated to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements. Non-routine audits include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope. Manages complex or business critical audits/issues in a supporting or leading role. Supports other auditors in planning, conduct and reporting of audits. Conducts Peer review of audit reports. Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities

Inspection Support

• Participates in regulatory inspections in a leadership role (e.g. host, backroom lead)

Training & Development

• Identifies training needs. Develops and provides training. Independently advises and coaches other auditors.

• Completes training requirements in a timely manner to ensure inspection readiness at all times.

People Management

• Able to supervise junior auditors/contractors and deputises for Team Lead, as required.

Project Management

• Leads initiatives and actively participates in key projects. Interacts with key stakeholders and is able to influence and effectively drive projects to completion.

Subject Matter Expert / Point of Contact

• Actively shares business area and regulatory knowledge/expertise. May act as a primary contact for internal and/or external stakeholders.

• Independently provides consultation and advice to Business Partners and the core business sector on quality and compliance processes/procedures.

• Interprets and applies regulations/policies to unique and/or complex issues, when required.

• Provides strategic input during the development of processes/procedures.

Teaming & Collaboration

• Establishes collaborative partnerships with peers, managers, and Business Partners to create an effective team environment.

• Independently and effectively organizes, coordinates, manages and executes team objectives.

• Provides strategic leadership on project teams to influence decision outcomes.

• Provides a high level of technical and relational contributions.

• Identifies issues and recommends actions towards effective solutions.

• Mentors and facilitates successful team behaviors and manages team dynamics.

Degree of Supervision, Autonomy

• Indirectly or directly leads or sets objectives and priotrities for others on team projects and tasks.

• Works independently, applying key learnings from management and past experiences.

Problem Solving

• Sound problem-solving skills with the ability to understand and independently resolve problems of difficult complexity.

Innovation

• Contributes to value creation in alignment with strategic direction of the department/organization/Business Partner as follows:

• Drives meaningful innovation through developing new ideas and solutions about specific issues.

• Challenges the status quo and adapts to change; takes a lead role in this change to result in a positive impact.

• Takes and properly manages risks.

• Leverages diverse perspectives, backgrounds and talent to generate effective ideas or solutions.

Communication & Influencing

• Uses fact-based evidence to defend position when challenged. Focuses on achieving the best outcome for the situation.

• Clearly expresses opinions and new ideas

• Creates an environment of open and transparent communication, contributing to collaborative, ethical and high-performing teams.

• Leads discussions, communicates complex issues and interacts effectively with Business Partners and Management at all levels. Demonstrates good negotiation skills. Influences internal Business Partners on best quality & compliance practices and to form quality mindset.

• Maintains awareness of the regulatory and industry environment, adding value and insights by influencing changes.

• Builds relationships with Quality professionals adding value and insights for the organization.

Qualifications

Education & Experience requirements

• A Bachelor of Science (BSc) or Arts (BA) degree or the equivalent in training and experience is required.

• Experience in R&D and or quality/ compliance

• Thorough knowledge of the drug development process.

• Expertise in one or more specific compliance disciplines (non-regulated, GLP, GCP, PV or computerised systems).

• Knowledge of procedural and records management requirements in a regulated industry.

• Prior pharmaceutical and quality/compliance related experience.

• Knowledge of auditing techniques is preferred.

• Excellent communication skills

• Fluent written and spoken English is required

• Team player

• Organized and detail oriented

• Sound problem solving and good negotiating skills

• Proficient in Microsoft Office applications

• Quality mindset

• Overnight travel, nationally and internationally, up to 40%.

What we’re about:

We are passionate about our work, and play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. We share a kind of DNA where we’re each

• Committed to caring

• Responsible to our communities

• Ready to apply our knowledge and know-how

• Unique in our background and experiences

• The drivers of our own success

• Passionate about doing what’s right

Make a unique mark in your career

If you want to be seen for the talent you bring to your work, be the driver of your own career, and work with others who share your passion for caring and success, then we invite you to join the Johnson & Johnson Talent Community by visiting www.careers.jnj.com

We respectively request Government Officials to identify themselves as such on application; for the purpose of the Foreign Corrupt Practices Act. If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson Medical, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.

Primary Location

United Kingdom-England-High Wycombe

Other Locations

Europe/Middle East/Africa-France-Île-de-France-Paris, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-Poland, Europe/Middle East/Africa-Italy, North America-United States-New Jersey-Raritan

Organization

Janssen Cilag Ltd. (7360)

Job Function

R&D

Requisition ID

1700188019W