Manager QRA, China – Ortho Clinical Diagnostics – Shanghai, China

Ortho Clinical Diagnostics (OCD) is a leading provider of in vitro diagnostic products and services, offering accurate, timely, and cost-effective solutions for screening, diagnosing, monitoring and confirming diseases. The company is a strong, highly competitive organization with approximately 3,800 employees worldwide, and sales, marketing and logistics on six continents.   OCD was recently acquired by the Carlyle Group, a highly respected global asset management company, as an independent, freestanding company. With new leadership and accelerated investment in research and development, OCD is well positioned for growth as a leading player in the global diagnostics market, tapping into rising demand for sophisticated medical diagnostic products and services worldwide.

The Career Potential: We are committed to enabling diagnostics to fulfill its vital role in the continuum of care and its importance as the focus of healthcare changes from treating sickness to promoting wellness. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. You will have access to a broad and exciting array of experiences, opportunities and new directions at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That’s something we can all take pride in as we take this journey together.   The Opportunity:     The Manager QRA, China provides strategic and tactical leadership for all aspects of Quality for OCD China and develops and executes the Quality strategy aligned with OCD processes and in support of company goals.  This role liaises with Quality, Regulatory, Commercial, Operations and Supply Chain business partners to provide strategic input and direction for China Quality.   The objective of this role is to have leadership oversight and accountability for the China quality management system and compliance program for OCD China, aligned with the OCD Quality System.  This position supports the commercial organization through execution of quality system elements as per the OCD Quality Manual.  This position manages key internal cross-functional relationships within OCD, as well as external relationships with in-country 3PL entities (distributors, suppliers), consultants, and localnational regulatory authorities.

This role will drive operational compliance to CFDA as well as provide VOC for the China region for product quality, regulatory and compliance issues.

The Responsibilities:

* Responsible for the Management of the Quality System for OCD entities in China.  Establish and implement country-specific quality system and regulatory procedures in aligned with OCD Global policy and procedures (SOPs, work instructions) and oversee processes in a compliant manner.

* Reporting of Manufacturer Incidents and Field Safety Corrective actions to the China Authorities.

* Declared as Pharmacist to the China Authorities for OCD China. * Coordination of the deployment of the customer notifications received through OCD Quality and International Regulatory Affairs. * Review of translation for procedures, IFU, Internet site.

* Monitoring of local China Regulatory Environment and feed-back to International Quality Regulatory Departments.

* Liaise with health authorities to ensure regulatory compliances and represent OCD to regulatory agencies on major policy matters or decisions regarding company products. Establish and maintain positive relationships with government agencies and other regulatory authorities.  Represent OCD China in matters before regulatory agencies in support of company goals.

* Prepare, coordinate and lead external regulatory agency inspectionsaudits (CFDA, ISO, etc).Maintain local quality system certifications, as applicable.  Perform duties of Quality Responsible person, as needed.

* Manage the OCD China distribution quality system framework as it relates to 3PL cold chain distribution management and transportation services. Provide quality oversight for pack-out qualification, environmental systems IQOQPQ, product disposition, and NCCAPA investigation relating to all distribution activities (cold chain and ambient storage, handling, transport).

* Design and maintain up to date quality training program.  Mentors and coaches departmental staff and cross functional teams Lead local QSMRs and Quality Review Boards and represent OCD China in OCD global QRB.  Support OCD QSMRs with regulatory andor quality updates pertaining to the China QMSRegulatory environment.

The Individual:

* University degree or equivalent in Life or Health Sciences required.  PhD or Pharma degree required.

* Minimum 8-10 years Quality and Regulatory experience in Medical devices, diagnostics, or pharmaceutical industry required.  Excellent bilingual oral and written communication skills (Fluent in English and Chinese).  Proven track record in participating in andor leading multifunctional “virtual” teams preferred. Strong communication skills required.

* Up to 10% domestic andor international travel.

Equal Opportunity: Ortho-Clinical Diagnostics, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law. Privacy Statement: Your privacy is important to us.  By continuing to use our site to apply to this position, you agree to our Candidate Notice, which outlines our privacy policies on information collected during the hiring process.

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