Associate Director, PV Inspection Management
Associate Director, Pharmacovigilance (PV) Inspection Management
Janssen-Cilag Ltd is recruiting for an Associate Director, Pharmacovigilance (PV) Inspection Management located in UK, Europe or East Coast USA.
This role will report to the Director, Pharmacovigilance Inspection Management who in turn reports to the PV Quality Assurance (QA) Domain Head. Together, we are part of BioResearch Quality and Compliance Quality BRQC.
Do you have knowledge, skills and experience in PV/PV audits/PV inspections, and the passion and creativity to shape the future quality landscape? If yes, we want you to join our diverse team here in BRQC where you will feel encouraged, supported and challenged to take your career to the next level and be who you want to be!.
We see the bigger picture and deliver on attention to detail.
Key business partners include: European Qualified Person for Pharmacovigilance (EU QPPV), Global Medical Safety, JJRC/PRC (responsible for oversight of PV compliance), BRQC 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.
We handle all inspection phases from start to finish:
- Co-ordinate pre-inspection activities eg management of pre-inspection document requests and agenda co-ordination.
- Drive inspection conduct (co-ordination of open and closing meeting, management of interview sessions, agenda management and execution).
- Implement post-inspection activities via collaboration with BRQC 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.
Tertiary Qualification e.g. University Degree
Experience and Skills:
- 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.
- Conduct of pharmacovigilance audits
- Conduct of pharmacovigilance inspections on behalf of a national Health Authority
- Hosting of inspections e.g. on behalf of a Marketing Authorisation Holder
- Excellent knowledge of pharmacovigilance harmonised standards and legislation driving global texts (eg European legislation, International Conference of Harmonisation (ICH) documents, Council for International Organizations of Medical Sciences (CIOMS)]
- Excellent written and verbal communication skills e.g. communication with Senior Leaders
Knowledge and/or experience in GCP audits and inspections, and excellent knowledge of GCP harmonised standards and legislation driving global texts (eg European legislation, International Conference of Harmonisation (ICH) documents]
[Travel: international travel to inspection location sites is required 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.