Biotech and Agricultural Finance and Economics Management & Business Others Medical and Healthcare
6 - 10 Years
Associate Director QA Clinical Team Lead
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 recruiting an Associate Director, QA Clinical Team Lead to support GCP audits within the Clinical Domain, BioResearch Quality & Compliance (BRQC) Quality Assurance (QA) organization.
Quality Assurance is responsible for the implementation and delivery of global cross-functional compliance audit programs to ensure that the development programs, Marketing Authorization Holders, functions, processes and systems for JANSSEN Pharmaceutical Companies (and all partners) are in compliance with company standards and Health Authority guidelines and regulations.
It is our mission to build QA of the Future by transforming the BioResearch Quality & Compliance (BRQC) audit function to be industry leading and by delivering innovative ways to proactively secure compliance and drive sustainability and reliability across R&D.
This position will be filled in the United States or Europe with preference if near a local office.
Main responsibilities will include, but are not limited to:
Directly responsible and accountable for supervision and development of direct reports.
Provide operational leadership over a team of Auditors and the audits they manage.
Lead the Auditors so that execution of audit is performed according to required timelines and following compliance within company and Health Authority guidelines and regulations.
According of defined scoping & risk-based strategies.
Coordinate resource allocation for assigned audits.
Establish and manage resource allocation within team, oversee workload of the staff to ensure efficient utilization of resources.
Set operational objectives for his/her team and ensures alignment with company, project team, departmental objectives.
Deputizes for QA Clinical Functional Management Director when requested.
Drives and implements talent strategies in a standard, fair and clear approach to ensure audit skills remain current to support business objectives.
Promotes a fair framework of recognition and reward, a mature sense open communication and mutual respect.
Cultivates an environment which encourages the company’s Credo commitment to equal employment opportunity and the value of a diverse workforce.
Provides useful feedback, and direction to teams. Fosters harmony within functional and other areas. Promotes the business value of different perspectives. Influences and persuades to bring about process and technical improvements.
Takes an active role in, and leads, projects and teams in key project initiatives across the organization or company.
Influences partners and determines priorities, checkpoints, and timelines for all aspects of work and projects to achieve adequate progress. Effectively drives projects to completion.
Is a great partner externally and internally for functional area. Builds cross-functional and cross-departmental support for innovative solutions. Furthers overall group effectiveness.
Conduct GCP audits & GXP Audits when applicable.
Collaborate with key business partners to lead the planning, conduct and reporting of BioResearch QA routine and non-routine audits across sectors including Pharmaceutical, Medical Device and Consumer.
Coaches and guides other auditors in the scope definition, planning, conduct and reporting of audits, providing expert advice.
Conducts peer review of audit reports.
Ensures the relevant standard procedures, audit scopes and audit plans are fully understood and applied in audit activities.
Proactively seeks solutions and contributes to the strategic direction for the resourcing and execution of the audit plans, schedule and inspection-related activities. Influences the effective implementation of audit processes ensuring global alignment and harmonization across domains and/or segments.
Provides support to auditors and business partners when developing and approving CAPAs. Influences consistency of CAPAs for similar issues. Drives resolution of complex CAPAs. Supervises the timely closure of CAPAs in his/her GCP domain.
Navigates and helps to support relationships during planning, conduct, reporting and CAPA with appropriate diplomacy.
Uses, encourages and supports direct reports to properly manage and document the risk-based approach in the audit planning and conduct.
Ensures appropriate resources are allocated to support Health Authority inspections.
Serve as the primary contact for applicable QA domain specific activities related to HA Inspections, including inspection readiness and coordinating with other functions as needed.
Training & Development:
Identifies training needs.
Develops training and development strategies for team to be able to support GCP/GxP compliance activities, collaborating within BRQC and with the business as required to ensure required skills are available to execute the audit schedule.
Provides career mentorship and ensures development plans are in place for reports. Ensures that each team member is knowledgeable about compliance in the assigned domain.
Proactively and independently coaches and mentors others to support talent development and training to meet current and future business needs.
Develops or is involved in the review and approval of training curriculum as applicable to area(s) of expertise.
Completes assigned training requirements in a timely manner to ensure inspection readiness at all times.
Actively supervises auditor skillsets and recommends actions to ensure the organization can support business objectives and maintain global alignment.
Monitoring base business metrics across team to ensure compliance.
Additional Skill Set:
Maintains experienced level GCP/GxP knowledge with the ability to provide critical information, advice and guidance on complex quality and compliance issues.
Apply and execute innovative BRQC QA audit methodologies focusing on reaching deeper quality and compliance insights.
Use data analytics tools to analyze relevant data sources. Evaluate and analyze the data to identify any relevant trends and insights as an input for the development of the appropriate audit program.
Provides expertise and knowledge to less experienced auditors, Business Partners and the core business sector on quality and compliance processes/procedures. Interprets and applies regulations/ policies to complex issues that drive policy and decision making.
Proactively identifies the need for and leads information sharing initiatives.
Serves as a primary contact for internal and external partners and represent BRQC in an experienced capacity.
Communicates internally to ensure a departmental unified position regarding advice and consultation is provided.
Collaborate with relevant business partners, global project teams, QP&S point(s) of contact to ensure robust audit plans within applicable therapeutic area program(s).Partner closely with QP&S to ensure “One” Quality Voice for GCP Domain risk assessments, aggregate analysis and management reports (Quality & Business Partners).
Skills, experience and education requirements of this role!
Bachelor's degree required; Advanced degree in scientific, medical or related field preferred.
Extensive experience working in Quality & Compliance, Clinical Operations, and/or related R&D area!
Experience managing people preferred
Knowledge of the drug development process, applicable regulations, R&D practices, and scientific and quality terminology is required.
Additional knowledge of medical device and consumer product regulations preferred.
Digital literacy & Analytics - Experience using standard applications/systems & data analytics tools is required.
Familiarity with new and emerging technologies and analytics, and ability to find opportunities where creative capabilities may be applied within QA audit processes preferred.
Experience conducting Quality Assurance audits is required in particular sophisticated/system audits & vendor audits.
knowledge of Good Clinical Practices (GCP) and applicable regulations/guidelines (e.g. FDA regulations, ICH E6 R2 is required.
Broad based technical knowledge and skills in diverse areas of business (e.g. R&D, Operations, QA, laboratories, etc.) are preferred.
Ability to interpret global regulatory standards.
Advanced knowledge of the fundamentals of clinical trial risk management required.
Broad knowledge of management of standard operating procedures, good documentation practices, and records management is required.
Inspection leading/hosting experience (FDA, EMA and other inspectorates) preferred.
Have excellent communication, organization, investigation, and negotiation skills, and be diplomatic.
Ability to be agile and plan and prioritize work in an efficient manner and work well under time constraints is required.
Travel Up to 20% required (national and international).
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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.
United Kingdom-England-High Wycombe- Other Locations
Europe/Middle East/Africa-Netherlands, Europe/Middle East/Africa-Italy, Europe/Middle East/Africa-Poland, Europe/Middle East/Africa-Belgium, Europe/Middle East/Africa-Germany, Europe/Middle East/Africa-Spain, Europe/Middle East/Africa-France Organization
Janssen Cilag Ltd. (7360) Job Function
Quality Requisition ID
Open Positions from Johnson & Johnson Family of Companies