Job Description:

MabPlex International Ltd an established CMO/CRO service provider for biologics manufacturing globally is looking to recruit a Director of Quality Assurance to join the senior management team, providing leadership and direction to the QA team across our highly CRO/CMO operations. The successful candidate will have a Biopharmaceutical/ Biologics QA manufacturing background gained within a GMP environment. The incumbent will work with internal stakeholders to ensure compliance with policies and procedures, and serve as the main point of contact for customer quality audits. The Director of Quality Assurance will lead and manage the strategic and operational performance of the Quality Assurance Department, within a GMP environment, ensuring the successful delivery of Business Strategy, Key Performance Indicators and objectives, whilst adhering to regulatory compliance to achieve commercial success.

Key Accountabilities:

1)Define, deliver & manage the QA strategy & processes ensuring best practice levels of compliance and quality adhering to regulatory standards. EMA / FDA GMP.

2)Ensuring that local management at all manufacturing sites are adequately resourced and operating in compliance with cGMPs and adhering to the principles of worldwide guidelines such as ICH.

3)Ensure that Quality Assurance Operations and supporting systems are delivered to support ongoing manufacture, batch release and all regulatory requirements across the site.

4)Provide hands on experience on continuous improvement of processes and quality standards across the sites.

5)Develop, monitor, improve and maintain procedures to ensure compliance with EMA / FDA GMP for the manufacture and testing of pharmaceuticals.

6)Manage the QA team, providing leadership, direction and ensuring uniformity in terms of QA approach and execution.

7)Ensure compliance to all facilities, systems & processes by maintaining a quality oversight of QA site operations needed for all product manufacturing, testing and release.

8)Define and present training collateral and content to enable the QA strategy with stakeholders both inside and outside of the department.

9)Oversee that deviations, changes and CAPAs are escalated and managed.

10)Manage documentation reviews in accordance with relevant Standard Operating Procedures.

11)Oversee batch release activities in accordance with relevant procedures, including issuing Certificates of Conformance for products.
 

Required Skills Education and Experience:

1. Advanced degree in Chemistry, Pharmacy, Microbiology or Biotechnology or another related science.
2. A minimum of 8 years of experience as the responsible person for pharmaceutical quality management and leadership in an international EMA/FDA/CFDA-regulated business.
3. Relevant and proven QA management experience in line management role, operating to GMP standards and regulatory expectations are essential
4. Experience of EMA / FDA and cGMP requirements for the manufacture and testing of pharmaceutical / biological / scientific products is essential
5. Experience of managing a large QA team within a highly regulated GMP environment
6. Experience building capability & operational robustness within teams & across sites
7. Proven track record in the planning, co-ordination and implementation of QMS
8. Excellent writing and presentation skills, strong interpersonal and teamwork skills
9. Ability to collaborate with department heads and meet timelines
10. Proficiency in MS-Word, Excel, and PowerPoint
11. Candidate must be fluent in both written and spoken Mandarin Chinese and English

Job Category: Quality Assurance

Travel: Minimal (<10%)

Location: Yantai, China

MabPlex, Inc. is an Equal Opportunity Employer