Senior Quality Assurance (QA) Manager conducts the following activities with minimal supervision of QA management (Note: “minimal supervision” is not expected to involve the supervisor being physically present at the audit):

• Performs contracted audits according to client expectations and/or Company SOPs

§ Plans and ensures audits are scheduled

§ Conducts audits to identify non-conformities in adherence to protocols, SOPs, regulations, GCP, and expectations for data accuracy and completeness

§ Reports non-conformities according to client or Company SOPs and report templates

• Tracks, collects and reports responses and corrective actions per contract with client or Company SOPs
• Performs internal audits according to master/annual quality plan and Company SOPs.

§ Plans and ensures audits are scheduled according to annual audit schedule

• Conducts audits to identify non-conformities in adherence to SOPs, regulations, GCP, and expectations for data accuracy and completeness
• Reports non-conformities according to Company SOPs
• Tracks, collects and reports responses and corrective actions as per Company SOPs
• Documents closure of audits
• Interprets regulations and guidance documents governing GCP and applies the interpretation to daily work for the Company staff and client representatives
• Researches the published information, interacts with other QA/regulatory professionals and maintains knowledge of current expectations and new trends and proposed changes to regulations
• Shares questions and issues posed to QA with more experienced QA staff and QA management as necessary to insure best advice is obtained
• Compiles response from QA staff and literature and replies to client and more broadly throughout Company as needed
• Manages client audits and regulatory inspections of Company to ensure that client auditors and inspectors receive access to needed documentation and staff with minimal disruption of ongoing operations
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Other accountabilities may include:

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  Maintenance of Quality Assurance Tracking System to ensure that reporting, tracking, trending and analysis of non- compliance issues is performed as required.
• Mentors and develops new QA staff.
• Deputy of basic QA management tasks in terms of audit activities in case of temporary absence of QA head.

上班地址：海淀区海淀西大街36号昊海楼8楼