Suzhou Site Quality Lead

Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.

Responsibilities:

• Supervise implementation of GMP (both medicine and health food), Medical Device, SOP and safety policy; ensure it meet related markets and Haleon standards.
• Ensure an efficient and technology-based quality management system, including change management, deviation, complaint handling, audit, improvement action, personnel health management, supplier management, material control, process control, traceability, etc., and ensure a continuous and effective process of document evaluation.
• Manage Suzhou site RA team (responsible for registration site initiated e.g. supplier, equipment and manufacturing process etc.) to ensure site registration process and all products comply with registration documents and Oversee the registration of site products together with Haleon China RA team / international Regulatory Affairs to ensure regulatory conformance.
• Ensure that raw materials, packaging materials, intermediate products, bulk products and finished products comply with the registration requirements and quality standards approved; Ensure the completion of necessary audit; Ensure the completion of inspection plan of product stability, provide the data of inspection about stability
• Ensure the completion of review of batch record before product release; Responsible for product release, ensure batch meet the production analytical registration requirement and meet product specification; File the related records. Maintain an efficient batch release process to enable the timely disposition of products. Ensure all the significant deviation and OOS is investigated and get timely managed. Ensure all the complaints related to product quality get investigated and get timely and properly dealt with. Participate AE report, product recall etc quality management activity.
• Approve quality standard, sampling process, test process and other quality operation procedure. Audit and approve all the change control related to quality. Approve and supervise inspection commission and contract manufacturing. Ensure the completion of production quality review and analysis.
• Review and approve the confirmation or validation report.
• Access and approve materials suppliers. Confirm and monitor the storage condition of materials and products.
• Supervise facility and equipment’s maintenance are in good operation conditions.
• Lead and drive site compliance training system to ensure employees are competent and appropriately qualified to perform their jobs and ensuring all internal and external requirements are adhered to.
• Responsible for Department people development, improve employee engagement; Ensure a robust and credible succession plan is in place for all key roles within Quality.
• Champion the interests of Quality in all management meetings or in any other interactions at the Haleon JV Suzhou sites. And participate & support the execution of site EHS management system.
• Effectively manage the audit program.  Ensuring ongoing acceptable audit status from internal and external audits. This includes adequate corrective and preventative action (CAPA) development for each major or critical observation arising from any audit, and monitoring progress against these actions on at least a quarterly basis.
• Effectively manage site Quality Council.  Operation of a governance process to ensure risk escalation, management and mitigation for Quality and Compliance issues (Quality Council). This includes evaluating the performance system utilised at site that requires management, allocate a certain percentage of time to monitoring and governance to assure appropriate checks and balances are sustainable.
• Accountable for functional risk management, includes proactive risk identification, assessment and mitigation plan development.
• Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
• Accountable for functional annual budget and resource management to achieve the target.
• Ensure that understand and comply with the applicable requirements of national and local laws, regulations, policies on Quality & EHS, the company's management system, Quality & EHS standards and policies, as well as make a consistent with company’s standard operation procedures.
• Other projects and tasks as assigned by the line manager.

Requirements:

• Bachelor or above degree, major in pharmacy, pharmaceutical sciences or related disciplines
• More than 10 years experiences of production and quality management. Have experience of quality control and quality assurance. Or equipped with equivalent knowledge and kill assessed by site. (e.g. sufficient training), Experience with GMP (China, PICS, WHO) and quality system auditing
• Familiar with GLP, GMP, QMS and regulatory conformance requirement
• Skill in using computer and office software
• Good English in all aspects, capable to communicate with foreigners about production management and technical equipment
• Strong leadership and team management ability, planning, communication and coordination skill
• Strong analysis and problem-solving ability
• Performance with Integrity, People with Passion, Accountability for Achievement

Diversity, Equity and Inclusion

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone.

We’re striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important note to candidates:
 
The Haleon recruitment team will only contact you using a Haleon email account (@haleon.com). If you are not sure whether the email you received is from Haleon, please get in touch. 

Accommodation Requests

If you require a reasonable accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please let your recruiter know by providing them with a description of specific accommodations you are requesting. We’ll provide all reasonable accommodations to support you throughout the recruitment process and treat all information you provide us in confidence.