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Johnson & Johnson 职业机会

Quality&Compliance, Manager

北京, 中国
Quality Control


职位描述

Requisition ID: 1905734814W

Quality Processes

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).

Regulatory Compliance

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.

Business Development

Vendor quality oversight

- Ensure local vendor compliance.

Business Quality

Management Review

- 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)

Talent development

- Build quality team, identify, develop and retain talent in the team, if applicable.

资历
Education

- 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.



Related Experience

- 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.



General Skills

- 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.

主要地点
中国-北京-北京-
组织
J&J (China) Investments Ltd A- Beijing Branch (7075)
工作
Quality Control
Requisition ID
1905734814W