职位详情

登录

Assoc. Dir, External Quality(J10500)
4.5-6.5万·13薪
人 · 本科 · 8年工作经验 · 性别不限2024/10/18发布
五险一金提成奖金交通补贴通讯补贴周末双休商业保险弹性工作定期体检年终奖金节日福利零食下午茶

one ITC

公司信息
欧加隆(上海)医药科技有限公司

外资(欧美)/1000-5000人

该公司所有职位
职位描述
工作职责:
Position Overview - Basic Functions & Responsibility
Essential function(s) includes, but is not limited to:
The incumbent is accountable for all activities at the External Entity (EE) site associated with the manufacturing of Company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution of the products manufactured at an EE and to assure they have been produced or tested following approved processes/ methods in conformance to all applicable regulatory requirements, regulatory filings and company policies.
The incumbent also ensures that effective and robust Quality systems are followed to comply with required regulations, policies and guidelines governing the External manufacture of materials for the Company (e.g. small molecules, biologics, sterile product, excipients, active pharmaceutical ingredients, intermediates, through direct oversight, support and technical advice, counseling to site leadership, and on-site supervision. The Associate Director may serve as a subject matter expert for External Quality and Division in specific Quality systems, technology platforms, regulatory expectations and/or EE management, and can represent the Company in forums on their area of expertise (both internal & external).
The Quality Lead role should be based (Shanghai, China) where the company is located, and should be able to effectively interact and be the primary quality contact with local Health Agency during routine communication/reporting and Health Agengy inspections to the Market Authorization Holder (MAH) entity or even Contract Manufacture Operations (CMO) site.02
Primary Activities
Primary activities include, but are not limited to:
May manage a team of Quality Assurance professions as direct reports. Holds regular 1-on-1 meetings and Employee Development Plan discussions.
Accountable for executing the performance management process including objectives setting, objectives approval, objectives revision, year-end accomplishment evaluation, and performance discussions with direct reports, when applicable.
Contributes to development of the department budget and tracks and controls expenses as needed to meet budget.
Exhibits our company Leadership Behaviors and provides a leadership example for the team.
Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc) both domestic and foreign.
Maintains and provides expertise on External Quality systems, tools, data, and processes on an ongoing basis.
Accountable for ensuring metrics are compiled, analyzed, and reported, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements.
May sponsor the interpretation and aggregation of financial/business data for External Quality Assurance and highlight concerns as appropriate to External Quality Assurance Management. Identifies and facilitates resolution of major deviations from financial or strategic plans. Coordinates the development, with the External Quality Assurance Senior staff, of the External Quality Assurance budget, Long Range Operating Plan, workforce planning, and other strategic activities as required. Analyzes headcount data to provide budget forecasts to management.
Accountable for oversight of an External Entity involving releasing of products for further processing with the assurance that the goods were produced or tested in conformance to all applicable policies and procedures of the Company and compliance with all governing regulations.
Accountable for Quality Control functions including oversight for product testing, as well as other relevant components as determined by applied Calibrated Quality Oversight.02 These components may include review of batch documentation and deviation investigations.
Ensures permanent audit readiness, regulatory inspection support and monitoring, effective complaint management, change control oversight, metric review, and review of annual product reviews. This also includes building effective quality systems at the External Entity and continuous improvement activities.
Manages workload within team scope.
Operates in a safe and efficient manner and in compliance with the Safety and Health Policy.
Amount of Travel Required: Ability to travel up to 25%, occasionally on short notice.
任职资格:
REQUIRED: Education and Experience:
Education:
- Minimum four year degree in Science, Engineering or other relevant technical discipline (e.g. BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred).
- The Quality Lead, and Quality Authorized Person should at least have 5 years working experiences in pharmaceutical production and quality management, and at least 3 years working experiences in sterile manufacturing and quality management.
- Must have strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships.
- Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.
Communicates in English and Chinese, both verbally and in writing.02
Preferred Experience and Skills:
- Prior management experience preferred.
- Moderate level of contractual and financial awareness.
- Previous experience participating in regulatory inspections.
- Be conversant with all domestic and foreign regulations and compendia governing plant operations.

相关职位
Associate Director, Quality Assurance ID172968
交通补助通讯津贴技能培训
质量总监4-5万·14薪
管理规范五险一金餐饮补贴
QA经理30-60万/年
免费午餐晚餐公司团建
查看所有职位
51米多多提醒你:在招聘、录用期间要求你支付费用的行为都必须提高警惕。 以招聘为名的培训、招生,许诺推荐其他工作机会,甚至提供培训贷款,或者支付体检 、服装、押金和培训等费用后才能录用工作的,都属于违法行为,应当提高警惕。一经发现,请立即举报,并向当地公安机关报案。

举报

招聘信息 > 上海招聘 > 质量安全招聘 > 上海质量/品质经理招聘

收藏

热门职位热门城市周边城市