Johnson & Johnson 职业机会
Requisition ID: 1905734814W
Process, systems and documentation
- Develop and manage local procedural documents.
Training and knowledge management
- 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.
Quality monitoring & compliance
- Develop Annual Quality Plan with remediation activities addressing compliance issues and risk signals;
- Coordinate and/or perform QC checks and remediation actions specified in Annual Quality Plan. Monitor progress and effectiveness of remediation actions;
- 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;
- On an ad hoc basis, perform delegated activities such as On-Site Quality Monitoring and file checks.
Data Quality, Metrics & Reporting
- Support system related data quality, e.g., TMS, CTMS;
- Oversee disclosure of data on public web, if applicable (CT.gov excluded).
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., T-Race, IRON);
- Coordinate or support special investigation and issue remediation activities.
Vendor quality oversight
- Ensure local vendor compliance.
- Monitor compliance metrics, audit findings and issues (including appropriate escalation);
- Support R&D and LOC Management Review in collaboration with LOC quality partners;
- Coordinate and/or participate in quality council, if applicable.
People Leadership (if applicable)
- Build quality team, identify, develop and retain talent in the team, if applicable.
- A minimum of a Bachelor Degree in Science (BSc) or Arts (BA) or equivalent is required. A minimum of 6 years of previous Pharmaceutical Industry experience is required, with at least 4-5 years of GCP experience within clinical research and development and/or quality assurance.
- Knowledge of the overall drug development process;
- 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;
- 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; Exceptional written and verbal communications skills;
- Experience in R&D process requirements to successfully drive Q&C productivity, strategy optimization, process improvements and efficiencies including development and management of CAPA and facilitation of Root Cause Analysis;
- 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.
- Problem solver;
- Proactive strategic thinker;
- Strong leader and collaborator;
- Highly committed to quality;
- Flexible and persistent;
- Good conflict handling/negotiation skills;
- Ability to independently plan, organize, co-ordinate, manage and execute assigned tasks;
- Excellent communicator and presenter , with excellent interpersonal skills and diplomacy;
- Excellent knowledge of English is required;
- Proficient in Microsoft Office applications;
- Able to create win-win situations with internal and external partners;
- Stakeholder contacts are frequent and require excellent interpersonal skills and diplomacy;
- Knowledge of the corporate structure and culture.
J&J (China) Investments Ltd A- Beijing Branch (7075)