Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, Regulatory and Quality Process Partnership within Global Regulatory Affairs, Quality & Compliance. This role is joining a globally located team, so can be based at any site within the High Wycombe, UK; Beerse, Belgium; Cork, Ireland; Leiden, Netherlands; Raritan, NJ; Spring house, PA; Titusville, NJ; La Jolla, CA.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management, and women’s health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com
GRA Quality & Compliance is a newly formed organization, created to enable a single point of contact across Janssen for all topics under the span of quality and compliance for GRA. The Regulatory and Quality Process Partnership team provides end to end, customer focused collaboration, driving proactive process improvement and sustainable compliance.
The Manager will support the GRA Therapeutic Areas and Regions. You will use business understanding to assess areas of potential risk and manage strategic discussions with GRA leaders to align on prioritized action plans. You will effectively manage issues, lead/support audits and inspections and drive process improvement to deliver simplification, efficiency, and customer satisfaction. You will build relationships with GRA colleagues to strengthen the understanding of quality and compliance. In this role, you will:
- Identify and understand complex problems and recommend effective, compliant solutions, appropriate for the GRA organization
- Provide balanced leadership, managing compliance risk and business need
- Mentor GRA colleagues on quality issues and CAPA management processes and system(s).
- Partner with GRA colleagues to develop and share understanding of emerging issues
- Partner with various Quality organizations to ensure audit and inspection readiness
- Support/lead audits (pre, during, and post audit activities)
- Lead and document nonconformance investigations and ensure alignment around standard methodology.
- Support process and system standardization initiatives; use GRA, Pharma, and Enterprise compliance policies, standards, practices, and metrics.
- A minimum of a University degree (e.g., Bachelor’s degree) is required
- A minimum of 6 years of relevant experience required (preferably in Regulatory Affairs, QA, or other compliance-related area) is required
- Strong verbal and written communications skills are required
- Demonstrated ability to resolve conflict, influence teams, and to build relationships without formal authority is required
- Knowledge of what the pertinent regulations cover, how they're applied, and what their implications are, and knowledge of interactions with health authorities (e.g., FDA, EMA, and MHRA) is required
- Strong understanding of how regulatory bodies approach inspections and how to respond to Health Authority observations is preferred
- Knowledge of Quality Management and Regulatory Compliance in an international, global context, and in a regulated healthcare environment is preferred
- Knowledge of Root Cause Analysis and CAPA development methodologies is preferred
- Experience of process excellence, process improvement methodology is preferred.
- Experience leading/managing/supporting audits and inspections is preferred.
- This job will be located in High Wycombe, UK; Beerse, Belgium; Cork, Ireland; Leiden, Netherlands; Raritan, NJ; Spring house, PA; Titusville, NJ; La Jolla, CA and will require up to 10% travel.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
United States-New Jersey-Raritan-
Europe/Middle East/Africa-Netherlands-South Holland-Leiden, 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-Ireland-Cork-Cork, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-California-La Jolla
Janssen Research & Development, LLC (6084)