Description

Associate Director, GCP Inspection Management

At the Janssen Pharmaceuticals Companies of Johnson & Johnson, we are recruiting for an Associate Director, GCP Inspection Management located in UK, Europe or East Coast US.

This role will report to the Director, GCP (Good Clinical Practice) Inspection Management & Regulatory Intelligence who in turn reports to the GCP Quality Assurance (QA) Domain Head. Together, we are part of Research & Development Quality Assurance (R&D Quality).

Do you have knowledge, skills and experience in Good Clinical Practices and clinical (GCP)/ clinical audits, leading GCP inspections, and the passion and creativity to shape the future quality landscape? If yes, we want you to join our diverse team here in R&D Quality where you will feel encouraged, supported and challenged to take your career to the next level!

We see the bigger picture and deliver on attention to detail.

Key business partners include: Janssen R&D Therapeutic Areas, Global Development (responsible for clinical operations), JJRC/ Pharmaceutical Regulatory Compliance (responsible for oversight of GCP compliance), R&D Quality CAPA Centre of Excellence (responsible for driving the investigation, CAPA development and inspection response activities).

We build strong and trusted relationships with Global Health Authority Inspectorates to deliver excellence for the end- to-end inspection process. By doing so we enable success by ensuring inspectorates have timely access to the required documents, interviewees, databases and tools.

Key Responsibilities:

We handle all inspection phases from start to finish:

• Co-ordinate pre-inspection activities e.g. management of pre-inspection document requests and agenda coordination.
• Drive inspection conduct (coordination of open and closing meeting, management of interview sessions, agenda management and execution).
• Implement post-inspection activities via collaboration with R&D Quality colleagues in the CAPA Centre of Excellence (e.g. investigation, CAPA development, inspection report response).
• Monitor and disseminate inspection outcomes from internal and external sources to shape Quality Assurance audit and inspection readiness activities.
• Administrative activities enabling governance and compliance e.g. management of Johnson and Johnson Inspection Management and record retention databases and tools.

Qualifications

Qualifications

Education:

• Tertiary Qualification e.g. University Degree

Experience and Skills:

Required:

• Conduct of GCP quality audits
• Requires at least 10 years of experience with 5 plus years’ experience and demonstrated leadership in a quality function working on complex and significant compliance topics
• Leadership in hosting of GCP inspections (e.g. on behalf of a Marketing Authorization Holder/Sponsor)
• Excellent knowledge of international regulatory standards on the conduct of clinical research (e.g. International Conference of Harmonisation (ICH), US and European Legislation)
• Excellent written and verbal communication skills e.g. communication with Senior Leaders

Preferred:

• Knowledge and/or experience in GVP audits and inspections, and excellent knowledge of GVP harmonized standards and legislation. (eg European legislation, International Conference of Harmonisation (ICH) documents, Council for International Organizations of Medical Sciences (CIOMS)].
• Conduct of GCP inspections on behalf of a national Health Authority

Other:

• English Language Proficiency – Both oral and written
• International travel to inspection location sites is required (up to 30%) although some inspections can be handled remotely.

Useful:

Gone above and beyond to sparkle? If yes, tell us if you have a certification! e.g. ISO certification, American Society of Quality (ASQ) certification.

Benefits: time in office versus time at home.

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.