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Senior Auditor, Quality (gmp/gdp) Compliance, Shanghai

发表 2025-01-25
过期 2025-02-25
ID #2568285013
Free
Senior Auditor, Quality (gmp/gdp) Compliance, Shanghai
China, 上海, 上海,
发表 January 25, 2025

描述

Job Description: General Description: The Senior Manager of GMP/GDP Quality Compliance supports the Bei Gene External Vendor Audit program to ensure the regulatory compliance status of Bei Gene and vendors.

The Senior Manager ensures that quality and compliance systems follow applicable global regulatory and health authority requirements.

This role supports Inspection Readiness and as such the Senior Manager evaluates external guidelines and regulations, ensuring visibility and awareness of emerging new or changing standards that effect the business of Bei Gene.

The Senior Manager GMP/GDP Compliance may also perform internal audits (Bei Gene Sties, CMO's, and affliates) and supports GMP/GDP regulatory inspections.

This position is hands on role within Global Compliance organization with global responsibility and cross-functional influence requiring primarily tactical decision making.

This position is China Remote based.

Essential Functions of the role: Execute the external vendor audit program.

Independently lead/participate in GMP/GDP compliance audits to ensure compliance with existing policies, procedures, standards, regulations, and guidelines and identify gaps or risks.

Develop, issue and manage audit reports and any associated quality events.

Conduct and/or support GMP/GDPP Bei Gene Internal audit program.

Support GMP/GDP Health Authority Inspections Maintain and report GMP/GDP compliance audit trends and metrics.

Develop and/or maintain SOPs and work instructions pertinent to the External vendor audit program.

Other duties as assigned Supervisory Responsibilities: This position may include managing globally located staff; coaching and mentoring of junior staff with training / orientation / qualification and development plan when required.

Qualification Required: Computer Skills: Strong MS Office Skills – Outlook, Word, Excel, and Power Point Other Qualifications: Bachelor’s degree in science or Professional Certifications.10+ years of experience in the pharmaceutical/biotechnology industry5+ years of GMP/GDP QA experience, 5 of which includes management experience, certification as a quality auditor (CQA) is desirable.

Knowledge and understanding of the current US and EU Good Manufacturing Practices (GMP) Good Distribution Practices (GDP), and International Conference on Harmonization (ICH) guidelines.

Understanding of Biopharmaceutical Manufacturing, Analytical Chemistry and Chemical Manufacturing and business processes.

Knowledge and understanding of practical quality assurance in the manufacturing environment, as well as laboratory controls and safety.

Excellent written and verbal communication skills, interpersonal skills, and technical writing skills.

Ability to work at a fast pace and multi-task Working Knowledge and experience with 21 CFR210 & 211, ICHQ7, 21 CFR600,21 CFR11, Eudralex Vol.

4, Chinese GMP 2010 as well as other international regulations pertinent to Bei Gene's global market.

Working knowledge of applicable ISO Standards Travel: May require up to 50% travel.

What We Offer To Our Valued Employees Market competitive compensation package including performance-based annual bonus scheme Company shares (generous welcome grant and performance-based annual equity plan!)In-house and external learning and development opportunities Fantastic benefits program and keep improving!Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.

Join us and Make momentum in your career!Bei Gene Global Competencies When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Bei Gene is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.

If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) Bei Gene’s Job

职位详情

工作类型: 全职
合同类型: 永恒的
薪酬类型: 每月
职业: Senior auditor, quality (gmp/gdp) compliance

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