发表於: 2019-01-10

职位类别: 长工

行业类别: 医疗保健

 
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A Biopharma (large molecure product) Enterprise is looking for a GMP Quality (Sr./Executive) Director to be based in Beijing.

This role will be responsible for:

- Identify opportunities to further enhance quality system and quality performance

- Proactively identify quality and compliance risks. Develop and implement effective remediation plan.

- Ensure inspection readiness by local and international health authorities.

- Ensure company's quality system (SOPs) meet local and international requirements, especially US and European countries.

- Ensure quality practice (change management, deviation investigation, OOS, CAPA, complaints, etc) meet regulatory authorities' expectations.

- Play a key role to promote company quality and compliance culture

- Identify training and skill gaps for quality and production personnel.

- Lead and coach team members.



Qualifications:

- Minimum 15 years experience in pharmaceutical/biopharmaceutical industry, 10 years in quality.

- Must have experience in preparing and handling US FDA, EMA inspections.

- Verbal and written English communication is preferred. Experience in multinational companies is a plus.

- Experience in QC is a plus.
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立即申请: GMP Quality (Sr/ Exeutive) Director
参考号码: CN141909

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