SCOPE OF THE POSITION:

Fulfill the virtual internal quality role of a site in the Contract Manufacturing Organization [CMO] manufacturing APIs, ABI, Finished Products, Diagnostics etc . The CQL should understand the operations at the shop floor, product characteristics and production process, documentation system, laboratory, regulatory (i.e. potential open commitments, inspections) and have a network established to escalate situations in a timely manner for the right audience. Ensure contractors have applicable quality systems and comply with GMP/regulatory requirements and Zoetis expectations for product. Implement Zoetis quality oversight strategy (i.e. VPT, quality visits) and follow-up routinely the health of quality management systems escalating issues when necessary. Implement, review and control metrics to ensure systems are under control. When required communicate applicable GMP, regulatory standards and Zoetis expectations to contractors and assist them in the adoption of these requirements into their local procedures and practice. Utilize Zoetis systems to perform tasks required to manage contractors including Trackwise and SAP.

The Manager Contractor Quality Lead is expected to:
• Understand the supply chain of products manufactured by CMOs/suppliers and work proactively to identify quality and compliance risks that can disrupt the business.
• Work independently in routine operations and complex operations for Global External Operations [GEO].
• Provide quality input to cross-functional teams at the CMO and internally (external supply, supply chain and logistics, regulatory and others) as the Zoetis quality representative for the CMO.
• Lead the investigation into significant quality concerns to ensure that the mitigation actions are appropriate and timely. May seek guidance for complex deviation investigations.
• Interact with middle management within GMS/Commercial Operations which includes negotiating and obtaining endorsement on quality decisions for significant quality matters.
• Assist with projects of quality performance, systems & continuous improvements.
• Participate to management escalation meetings and ensure that decisions are taken in a scientific, fact-based approach.

JOB SUMMARY - MAIN AREA’S OF RESPONSIBILITIES / ACCOUNTABILITIES:

Contractor Management: The following routine activities are performed by the Manager in quality oversight of a Tier 2 contractor:

 Quality Agreement: Negotiate terms of the quality agreement template and make sure the implementation of the content of this agreement is approved before the production of commercial batches. May seek guidance on changes to standard template to ensure acceptability. Maintain agreement by reviewing on a periodic basis to ensure its compliance.

 Change Management: assess product related change proposals from a quality and regulatory standpoint. Process the acceptable changes and manage the timing of implementation of change at contractor. May seek guidance when required. Elevate the topic to the management of both companies if needed.

 Deviation Management: Evaluate the impact of all significant deviations generated at the contractor, elevate and perform actions as required. May seek guidance for complex deviation investigations. Determine which level of escalation and actions is appropriate and engage other organizations based on risk and impact.

 Product Disposition Level Assignment and Batch Release: Apply the lot disposition process for Zoetis products which have been released to Zoetis by the contractor; Perform yearly risk assessment to determine applicable lot disposition process.

 Complaints Management: manage independently and work with the pharmacovigilance team on the external market complaint process by ensuring that all justified complaints requiring investigation at the contractor level are answered in a timely manner and that the contractor investigation report is appropriate and meeting requirements.

 Materials Management: For Zoetis tolled materials, act as a quality single point of contact managing quality audits, complaints, deviations and any other regulatory required information from the supplier.

 Annual Product Reviews (APR): ensure that APRs are obtained timely from the contractor for Zoetis products, properly reviewed and endorsed by the CQL and any required corrective or preventive actions are defined and implemented in a timely manner.

 Stability: Maintain oversight of the stability program for regulatory and Zoetis commitment based on internal procedures and quality agreement. The CQL should own the system and control the following activities – review the annual stability plan with the contractor, follow-up the pull-out dates and assess the results obtained. May seek guidance to determine if any potential out-of-trend result needs to be escalated. Report the results as required within Zoetis and share the data with the regulatory team when needed.

 Qualification and Technical Activities: Review and approve technical documents from the contractor that may have an impact in Zoetis product from a quality and compliance standpoint. All Zoetis product related documents should be controlled by the CQL.

 Auditing: Perform a risk assessment of the need for auditing the CMO in a routine basis. Co-ordinate, facilitate and participate in the audit process. When needed, independently perform audit at CMOs and/or suppliers.

 Site Transfer and New Product Introduction Activities: Act as liaison of quality matters related to a site transfer (API/product production being transferred from a site to another and/or a new product is introduced) – laboratory, production and documentation activities should be proactively driven by the CQL ensuring quality gaps are mitigated before the commercial launch. May seek guidance on required activities and acceptable execution.

 Regulatory Activities: Possess a high-level understanding of the regulations to ensure those regulatory expectations are met. Demonstrate proficiency interacting with the RA colleagues within the required markets. May seek guidance on accuracy of regulatory submissions.

 BoH Inspections: Monitor and report upcoming inspections and results. May seek guidance on appropriate CAPA response.

 Artwork: Ensure AW is reviewed per applicable procedures.

 Other: As part of a global team, the CQL should be also working improving the Zoetis ESQA quality systems, sharing best practices, benchmark with other colleagues from different regions and establishing an internal network of subject matter experts for continuous improvement.

TECHNICAL SKILL REQUIREMENTS:

 Level of Education: Bachelor/Master degree in Pharmaceutical Science, Microbiology, Chemistry or equivalent;

 Experience: Relevant experience in regulated industry particularly in quality (assurance/control), manufacturing, auditing, technical (i.e. engineering, R&D) or regulatory areas.

 Languages: Fluent in English and local language and ideally knowledge of other regional languages.

 Product/Regulatory Knowledge: Demonstrate knowledge of a range of products and regulatory requirements in a diverse portfolio of products (ideally Animal Health).

 Profile: Possess appropriate negotiation, communication, and organization skills Capable of resolving conflicts in a diplomatic manner. Takes initiatives and is proactive in identifying issues and bringing forward ideas to resolve.

Able to participate in multiple projects, prioritizing own work. Elevate items as required to Regional ESQA quality leader.

Is customer-oriented and willing to travel up to 20 %.

其他信息
语言要求：英语