北京招聘

职位描述：
General Summary
Manages overall quality, compliance, and auditing activities to ensure compliance of operations with corporate policies, industry standards, and applicable regulations by conducting audits of, e.g. trial master files, clinical sites, and vendors used to support clinical trials.

Performs contracted and internal audits. Evaluates non-conformities and reports findings. Consults with Company staff for interpretation of regulations.

Works individually and within teams to support Quality IT Compliance. Individual will develop and document test strategies to perform quality driven validation for Company’s solutions that use Microsoft, Programming languages and SQL technologies.


Primary Accountabilities
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 aunnual audit 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


Other acountabilities may include:
? 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.


Qualifications
 University Degree in a biomedical or related life science. A second engineering qualification is beneficial
 Minimum 2+ years of experience in Quality assurance or Quality Control in GCP, GCLP or PV.
 Global experience in a CRO Quality Assurance environment is beneficial.
 Minimum 8+ years of experience in clinical research, in the roles of Clinical Monitoring, Project Management, Data Management or Pharmacovigilance.
 Excellent English language proficiency. 举报 分享

康德弘翼（WuXi Clinical），是药明康德（WuXi AppTec）的一家全资子公司。始终致力为全球客户提供全方位的临床研究服务，包括药品、生物制品、医疗器械、体外诊断试剂等医药产品。从I期临床研究到最终申报注册，通过严格的质量控制体系和专业团队的丰富经验，帮助创新性，突破性医药产品尽快上市和造福患者。

康德弘翼立足中国，面向世界，以上海总部为中心，辐射全球制药公司、生物技术公司以及医疗器械公司。目前，公司实行中美联合运营，人员规模达850人，覆盖中美两地，全国30多个主要城市，在上海、北京、广州、武汉、成都、长沙、西安、沈阳和美国奥斯汀、圣地亚哥10个城市均设有办公室。公司团队与各研究中心建立了良好的合作关系，始终保持着紧密的业务交流，保证了项目能高效、高质地完成。

随着业务能力的不断提升，我们已将业务范围成功扩展到美国、欧盟和亚太地区的部分国家。2018年7月，药明康德成功收购位于德克萨斯州的一家美国临床研究机构并实现中美联合运营，2019年5月，再一次收购了位于圣地亚哥的临床研究服务公司Pharmapace，这让WuXi Clinical的规模再一次得到扩大，进一步完善和增强了我们全球一体化研发服务平台的综合实力，帮助全球创新合作伙伴更好、更快地开发医药产品。