全球领先的动物保健公司因业务需求新招职位，要求有独立负责质量审计工作，英文口语熟练沟通，可接受50%出差。上海或苏州工作。感兴趣可把简历发到karen.kong@db-talent.cn

POSITION TITLE: Regional Compliance Auditor (RCA)

POSITION SUMMARY

Summarize the primary purpose & key accountabilities of the position, including scope of responsibility in 5-7 concise sentences. (i.e. Global vs. Country/Region) It may be helpful to complete this section after you have finished the other sections of the document.

The Regional Compliance Auditor will conduct on-site audits of COMPANY manufacturing sites, contractors and suppliers – with the goal of determining compliance gaps and necessary remediation plans. The auditor will promptly deliver/communicate audit findings using predetermined processes and methodology.

The RCA will (as needed) assist with mock regulatory inspections as well as supporting agency inspections. Additonally – the auditor will gather, track, trend, and disseminate regulatory compliance findings – from internal as well as external inspection sources.

The RCA will work closely with QSS and Surveillance colleagues to stay abreast of current compliance regulations and points of key inspection trends.

POSITION RESPONSIBILITIES

In order of importance, list the primary responsibilities critical to the performance of the position. It is recommended not to list actual tasks but focus on essential responsibilities that highlight accountability and level of judgment required.

? Conducting quality audits of global and regional COMPANY Global Manufacturing and Supply Sites (GMS), Suppliers and Contractors

? Conduct Mock PAI and inspection readiness assessments at GMS Sites and contractors

? Support due diligence assessments

? Support regulatory agency inspections and conduct risk assessment of regulatory agency observations

? Follow up and tracking of CAPA completion

? Train sites and center colleagues on conducting audits (auditor qualification)

? Provide technical expertise as requested and conduct business interactions in ways that reinforce and compliment COMPANY quality assurance programs.

? COMPANY Quality Culture ambassidor

ORGANIZATIONAL RELATIONSHIPS

Provide the primary groups or key positions that this position will have interaction with as a regular part of the positionresponsibilities. Include any external interactions as appropriate.

? Manufacturing Operations

? Manufacturing GMT

? QSS, QPL

? VMRA VMRD

? GSS

? ESQA, SCQO

? Manufacturing IT

RESOURCES MANAGED

Supervision

? Highly matrixed organization; Influence without authority necessary

EDUCATION AND EXPERIENCE

Indicate the formal education, certification or license required and/or preferred.Include the minimum number of years of relevant experience required for the position (where legally permissible).

? Science or Engineering Bachelors / Masters Degree

? Significant Operations and/or Quality experience (5+ years) in Animal Health/Human Health manufacturing

? Previous Animal Health/Human Health audit experience

? Demonstrated ability to operate successfully in a matrix organization

? Six Sigma Black Belt / Green Belt or Lean Practioner Preferred

? Experience in working with FDA, EU, USDA, Chinese regulations.

TECHNICAL SKILLS REQUIREMENTS

Indicate the technical skills required and/or preferred, as applicable.

? Demonstrated knowledge in Quality Operations

? Fluent with compliance regulators

? Excellent communication skills (written, oral, and listening)

? Demonstrated independent contributor and ability to manage independently

? Deep expertise in planning, organizing, and follow up methodology; punctual

? Ability to develop and adhere to self-directed standard work.

? Ability to analyze data and synthesize to enable tracking and trending of large issues

? Process Owner Management

? Continuous Improvement; Systems and Process mindset

PHYSICAL POSITION REQUIREMENTS

Note the physical conditions in which work will be performed, if applicable to the position. Examples: Lifting, sitting, standing, walking, ability to travel, drive, unusual attendance requirements, weekend work or travel requirements, etc.

? Position requires flexible work hours, to accommodate varying sites, locations, and markets’ time zones

? This position will require fluent use of teleconferencing and Webex tools, as well as Sharepoint technologies, to share and manage information with global locations and manufacturing sites

? Travel: Estimated 50% global travel

ACRONYM DEFINITIONS

? QSS: Quality Systems and Standards

? QPL: Quality Platform Leader

? QA: Quality Assurance

? QC: Quality Control

? ESQA: External Supply Quality Assurance

? SC QO: Supply Chain Quality Operations

? GMS: Global Manufacturing and Supply

? VMRA: Vetrinary Medicine Regulatory Affairs

上班地址：上海

我们拥有专业的招聘顾问和专员，具有有多年的猎头从业经验，丰富的经历和广泛的当地人脉，借助公司信息系统能为客户提供高效，专业，准确的人才搜索服务。

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1. 帮助高端人才主动出击，根据需求提供海量，成为高端人才的私人职业顾问。
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