Associate Director, Gcp Inspection Management
5 months ago
**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.
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.
-
Associate Director, Pv Inspection Management
5 months ago
High Wycombe, United Kingdom Johnson & Johnson Full time**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...
-
Specialist QA Gcp Auditor
5 months ago
High Wycombe, United Kingdom Johnson & Johnson Full time**"Caring for the worldone person at a time” **inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion...
-
Associate Director, Safety Analysis Scientist
5 months ago
High Wycombe, United Kingdom Johnson & Johnson Full time**Associate Director Safety Analysis Scientist**: Johnson & Johnson Innovative Medicine is recruiting for an **Associate Director Safety Analysis Scientist (AD SAS) **, located within commutable distance of High Wycombe, UK. The AD SAS provides scientific expertise and leads the safety assessment of assigned products. In partnership with the Medical Safety...
-
Associate Director, Safety Analysis Scientist
5 months ago
High Wycombe, United Kingdom Johnson & Johnson Full timeThe Associate Director (AD) Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned products. The AD SAS, in partnership with the Medical Safety Officer (MSO), is responsible for the preparation of scientific safety analysis and evaluations, which are required for regulatory compliance and to aid in...
-
Associate Director Commercial Property Management
7 months ago
High Wycombe, United Kingdom Rayner Personnel Property Full timeDirector of Commercial Property Management - High Wycombe - Generous salary and reputable company My client, based in High Wycombe, is looking for a Director to head up their Commercial Property Management sector. Generous basic, superb company and an ever growing Commercial Property book to manage
-
Local Compliance Specialist
5 months ago
High Wycombe, United Kingdom Johnson & Johnson Full time**Local Compliance Specialist**: **Location: United Kingdom**: We are looking for a clinical research professional with a passion for quality. The Compliance Specialist will be responsible for performing activities that ensure we conduct clinical trials to the required legal and quality standards. You can be based at home or in the office. This exciting...
-
Scientific Knowledge Management Associate
5 months ago
High Wycombe, United Kingdom Clinical Professionals Full time**Reference Number: JO-2201-484262** Scientific Knowledge Management Associate Rate: Negotiable **Job Type**: Contract Location: High Wycombe Scientific knowledge management (SKM) associate Contact till the end of 2021 High Wycombe based office requirement 3 or 4 days per week PAYE - £30.20 - To provide operational and administrative support to members...
-
Clinical Services Director
4 weeks ago
High Wycombe, Buckinghamshire, United Kingdom DS Associates Full timeWe are seeking a highly skilled Clinical Services Director to join our team at DS Associates. The successful candidate will be responsible for leading the clinical services operations within our inpatient hospital for adults with eating disorders.This is a 14-bedded, specialist eating disorder service for mixed-gender adults. The hospital is located in a...
-
Clinical Services Director
4 weeks ago
High Wycombe, Buckinghamshire, United Kingdom DS Associates Full timeWe are seeking a highly skilled Clinical Services Director to join our team at DS Associates. This is a fantastic opportunity for a motivated and experienced professional to lead our clinical services operations in an inpatient hospital setting for adults with eating disorders.The successful candidate will be responsible for ensuring the highest level of...
-
Strategic Planning Director
21 hours ago
High Wycombe, Buckinghamshire, United Kingdom Carrington West Full timeJob OverviewCarrington West is assisting a leading private consultancy in Buckinghamshire, who are seeking to expand their planning team with an experienced Town Planning Director or Associate Director.
-
Quality Officer
6 months ago
High Peak, United Kingdom Concept Life Sciences Full time**The Company** Concept Life Sciences is a knowledge based, science led business focused on delivering the expertise and capabilities our clients demand. We work in the pharmaceutical, biotechnology, food, environmental, agrochemical, petrochemical chemical and consumer products sectors. Our business is home to Scientists with in-depth experience in their...
-
Senior Financial Director
4 weeks ago
High Wycombe, Buckinghamshire, United Kingdom Michael Page Finance Full timeThis position is for a Senior Financial Director in the Insurance industry, based in a leading company. The successful candidate will operate within the Accounting & Finance department at a Senior Manager/Senior Associate level.Client DetailsThis is a large-scale business in the insurance industry. The organisation prides itself on its strong market presence...
-
Adult Clinical Director
2 weeks ago
High Wycombe, Buckinghamshire, United Kingdom Compass Associates Full timeAre you a seasoned Clinical Lead looking for a new challenge in the UK's mental health sector? We're seeking a dynamic and experienced professional to join our team at Compass Associates as Clinical Lead for a specialist Eating Disorder service in Adult care.This is a fantastic opportunity to lead and shape the clinical operations of our service, working...
-
Commercial Quality Associate
5 months ago
High Wycombe, United Kingdom Johnson & Johnson Full timeJ&J Innovative Medicine is recruiting for a **Commercial Quality Associate **to be located in UK. The Commercial Quality Associate works in the Commercial Quality Team based in the UK, which is part of the EMEA Commercial Quality Organisation. We are looking for a Quality Associate to join our team on a permanent basis reporting into the Quality Manager UK....
-
Scaffold Inspector
1 month ago
High Wycombe, United Kingdom CV-Library Full timeGilmartins is a family owned and run business; our staff are valued and our ethos is to promote from within. Our Board of Directors mostly started on the tools themselves so have a ‘hands-on’ understanding of the work we do. We work in social housing and provide reactive repairs for local authorities and housing associations. We are looking to...
-
Scaffold Inspector
3 weeks ago
High Wycombe, Buckinghamshire, United Kingdom Gilmartins Full timeGilmartins is a family-owned and run business with a strong ethos of promoting from within.Our Board of Directors, comprised of ex-trade professionals, have a hands-on understanding of the work we do.As a qualified Scaffold Inspector, you will be working in social housing, providing reactive repairs for local authorities and housing associations.Key...
-
Senior Care Home Director
4 weeks ago
High Wycombe, Buckinghamshire, United Kingdom Compass Associates Full time £50,000Job Title: Senior Care Home DirectorJob Summary: We are seeking an experienced Senior Care Home Director to lead our team and ensure the highest standards of care are consistently delivered.Key Responsibilities:* Lead and nurture a team, ensuring continuous improvement in care standards.* Develop and implement care plans that meet the needs of our...
-
Senior Nursing Home Manager
4 weeks ago
High Wycombe, Buckinghamshire, United Kingdom Compass Associates Full timeSenior Nursing Home Manager OpportunityWe are seeking an experienced Senior Nursing Home Manager to join our team at Compass Associates. The successful candidate will have a strong background in nursing home management, with a focus on elderly care and dementia nursing.Key Responsibilities:Lead a team of nurses and care staff to deliver high-quality care to...
-
High Wycombe, Buckinghamshire, United Kingdom Gilmartins Full timeWe are seeking an experienced Scaffold Inspector and Roofer to join our team at Gilmartins. As a valued member of our staff, you will have the opportunity to work in a family-owned and run business that promotes from within. Our Board of Directors has a hands-on understanding of the work we do, ensuring that our employees are empowered to grow and develop...
-
Sales Director for Inside Growth
1 week ago
High Wycombe, Buckinghamshire, United Kingdom Harrison Scott Associates Full timeJob Overview:Harrison Scott Associates is seeking a seasoned Sales Director to lead the inside sales organisation and drive growth in this key role.About the Role:In this dynamic position, you will be responsible for building, leading, and managing a high-performing team of Sales Executives to achieve revenue targets.Main Responsibilities:Develop and...