Ref #: 26109

Employment type: Permanent - Full-Time

Location: China-Beijing

Posted: 31-Mar-2021

Description

Quality and Compliance Oversight Activities
• Monitor compliance risk and ensure mitigation/remediation actions are defined
• Monitor progress and confirm effectiveness of remediation plans, perform special investigations and plan, prepare, conduct and report QC checks and compliance assessments to ensure risk signals are addressed in a timely manner. More specifically perform the following risk-based activities:
o Conduct On-Site Compliance Monitoring Visits
o Perform assigned reviews of Trial Master File, training compliance documentation and other checks per QP&S Integrated Quality Plan for the trial
o Planning and execution of local QC checks
o Support and advise local and central study teams in root cause analysis of significant observations
o Ensure appropriate filing of the QC reports
• Conduct Quarterly Quality Reviews with local GCO management addressing compliance issues and risk signals
• Collaborate with local and central business partners to facilitate (local) inspections and office audits as needed


• Collaborate with local and central business partners in timely CAPA setting and implementation. Provide Quality Event Management (QEM) CAPA Champion support and/or regional lead responsibilities such as training, account management, etc
• Initiate and lead continuous improvement initiatives that show demonstrable impact to the business and processes
• Develop and manage local procedural documents
Local Onboarding and Consultation
• Support onboarding of new hires
• Manage local workshops to support QMS and compliance awareness, Lessons Learned, etc
• Provide advice regarding SOP, system and GCP questions. SME in most areas.
• Go to person for managing risk at the country level, including assessing root causes and developing effective actions to mitigate risk.
Local regulatory intelligence
• Perform impact assessments of new/revised local regulations, guidance and standards
• Support central functions in ensuring local intelligence is up to date (e.g., RIACS, T-Race, IRON)
Collaboration with Business Quality
• Support LOC Management Review in collaboration with LOC Business Quality partners
• Coordinate and/or participate in quality council, if applicable
• Support local supplier assessments as appropriate
• Coordinate annual Due Diligence update, certification and training of local suppliers, if applicable

Principal Relationships:
The Local Compliance Manager has a reporting line into the GCO China Local Compliance Team Lead and is a member of the AP Compliance team.

Education and Experience Requirements:
Education:
A minimum of a Bachelor Degree in Science (BSc) or Arts (BA) or 6-8 years relevant experience equivalent is required. A minimum of 6 years of previous Pharmaceutical Industry experience is required, with at least 3-4 years of GxP experience within clinical research and development and/or quality assurance.
Related Experience:
• Knowledge of the overall drug development process
• Well-developed skills and knowledge of business processes and practices (i.e., SOPs governing clinical research activities)
• Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset
• Ability to translate data into information and strategies into executable action plans improving the business
• Ability to motivate professional colleagues and stakeholders
• Conflict resolution/management and negotiation skills
• Ability to independently plan, organize, coordinate, manage and execute assigned tasks
• Experience of the key customers’ business processes and practices
• Excellent working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development
• Experience with regulatory submissions (NDA, BLA) is an asset
• Strong personal leadership skills with demonstrated competency interfacing with all levels of the organization including senior leaders; Strong networking and relationship building skills; Ability to create an open and inviting environment; Embraces generational differences
• Experience in R&D process requirements to successfully drive GCO Compliance productivity, strategy optimization, process improvements and efficiencies including development and management of CAPA and facilitation of Root Cause Analysis
• Demonstrated project leadership skills. May serve as a back-up for GCO Regional Compliance Leader

General Skills:
• Problem solver
• Strategic thinker
• Leader and collaborator
• Highly committed to quality and compliance
• Flexible and persistent
• Good conflict handling/negotiation skills
• Able to create win-win situations with internal and external partners
• Knowledge of the corporate structure and culture
• Impact - Complexity and Scope: Contributes to the definition and development of new processes, standards or operational plans in support of the organizational/ business strategies, with a direct impact on business unit/function overall results. May have responsibility for project budgets or functional budgets. Typically has responsibility for smaller scope projects and participate in multi-functional projects. Manages limited number of projects, including some of moderate complexity. Leads smaller scope projects. Contributes to local, regional and/or global strategy.
• Nature of Communication: Influences or persuades others within area of immediate responsibility, scope and level to accept new ideas, approaches and concepts. May interact with internal and external colleagues with coordination between departments. May represent J&J or company externally with some degree of supervision
• Innovation: Proactively anticipates issues; exercises judgment in developing new approaches/solutions and resolving issues within immediate area of responsibility and scope

Other Skills and Abilities: Requires limited supervision and functions with autonomy. May directly or indirectly lead or supervise other employees for small projects/teams. Possess excellent written, oral communication, interpersonal skills, diplomacy, and presentation skills and outstanding customer service.

Other:
• Excellent knowledge of English is required
• Proficient in Microsoft Office applications