Associate Director Business Operations

Conteúdo do emprego

Description:

Associate Director Business Operations

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

We are seeking an Associate Director Business Operations to join our Integrated Data Analytics and Reporting (IDAR) team within the Global Development organisation, Innovative Medicine, to be located in the United Kingdom or Belgium. The IDAR business comprises: Data Management Central Monitoring, Clinical Data Standards and Transparency, Regulatory Medical Writing, Clinical & Statistical Programming, Integrated Clinical & Operational Analytics, Clinical & Portfolio Systems, and Business Operations.

IDAR Business Operations (IBO) is accountable for establishing, maintaining, and continuously optimizing business operational activities, to enable high quality results (time, cost, and quality), with a particular focus on leading strategy & operations for IDAR. This is accomplished by using a broad knowledge of IDAR functions, drug development, and business operations, developing highly effective cross-functional relationships and using data/insights to improve key results. Key focus areas are:

• Financial & Resource Management
• Business Management
• Operational Excellence
• Business Operations Oversight of Suppliers
  
  

This position is an Associate Director level position responsible for compliance management across all IDAR functions.

Are you ready to join our team? Then please read further!

Key Responsibilities:

Lead all aspects of compliance risk and ensure mitigation/remediation actions are defined.

Oversight of a team of CAPA Champions supporting IDAR CAPA activities.

Ensure balanced workload across team members as well as ensuring that all CAPA activities are on track for completion.

Act as a CAPA Champion for when functional roles in IDAR are assigned as Investigator Owners of a nonconformance.

• Assist the functional Investigation Owner (IO) in the application of structured problem-solving methodologies in Root Cause Analysis (RCA) investigations (Fishbone, 5 Whys, etc.) independently or in support of the Root Cause Investigation team.
• Mentor the IO in the understanding of their end-to-end accountability of the entire CAPA process.
• Aid the IO to ensure process requirements are met.
• Collaborate with other CAPA managers/Champions in the management of complex CAPAs and process-related activities.
• Handle requests for assistance from the Trackwise central data entry team on behalf of the IO.
  
  

Be the single point of contact to the BRQC CAPA review board, BGIA, Partnerships, and CAPA Champions Community of Practice.

Act as process and system SME for the nonconformance & CAPA process and business/system requirements.

Develop Audit preparedness plan for IDAR functions including checklists of critical activities to be completed prior to any audit.

Work with internal project teams to conduct audit preparedness checks on key projects.

Develop and maintain a core set of metrics that will demonstrate IDAR compliance and audit readiness.

Point of contact for Partnerships for supplier CAPAs

Perform oversight of IDAR compliance including training, time reporting, vTMF compliance, etc.

Coordinates and leads (as assigned) critical initiatives to help improve the overall performance of IDAR against business priorities.

Leading and implementing consistent operational processes across IDAR, driving standard methodologies, sharing key findings, overseeing data quality, and providing mentorship.

Qualifications:

Qualifications

Education:

Bachelor’s degree (University/college degree) or above in a scientific field or general management is required.

Experience and Skills:

Required:

• At least 4-6 years of GXP experience within clinical research and development and/or quality assurance is required.
• At least 8-10 years experience in diverse professional experience compassing program/project management, business operations in the pharmaceutical/biotech industry is required.
• Experience of Quality Control and Compliance, CAPA process, Quality Assurance and RCA is required.
• Well-developed skills and knowledge of business processes and practices (i.e. SOPs, etc.)
• The ability to multi-task, work with minimal direction, make decisions, and achieve results in a fast-paced environment.
• Have a highly analytical mind, comfortable working with, joining and analysing data is required.
• Understanding of FDA/ICH and country-specific regulations and guidelines related to clinical development
• Experience with regulatory submissions (NDA, BLA) is an asset
• Experience in handling internal partners is required.
• Excellent communication and influencing skills and ability to establish strong and enduring relationships in a global matrix environment as well as the flexibility to work in a rapidly growing and changing organization is required.
• Experience in working in cross-functional teams, leading large projects and leading small teams
• Effective leadership skills and proven track record to cultivate team efficiency and cohesiveness in changing environment is required.
• Proven project leadership skills are required.
  
  

Preferred:

Experience in quality assurance activities, including audits of clinical investigator sites, systems and vendors, and audits of regulatory submissions is preferred.

A good understanding of clinical development, and data management, clinical data programming, clinical risk management – central monitoring and medical writing practices is preferred.

Other:

Up to 10% international travel is required.

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]