Document Control à United States

About US:

Zuellig Pharma is a leading healthcare solutions company in Asia, and our purpose is to make healthcare more accessible to the communities we serve. We provide world class distribution, digital, and commercial services to support the growing healthcare needs in this region.

The company was started a hundred years ago and has grown to become a multibillion-dollar business covering 17 markets with over 12,000 employees. Our people serve more than 200,000 medical facilities and work with over 450 clients, including the top 20 pharmaceutical companies in the world

Purpose of the Role:

The Regional Quality Compliance Manager takes the lead to establish, implement and maintain Zuellig Pharma Regional Quality Management System (QMS) encompassing the company quality vision, mission and policies, relevant ISOs and GxP, industry best practices and trends, Clients’ and Customers’ requirements to ensure standardization across Zuellig Pharma Markets.

The Regional Quality Compliance Manager is appointed as Document Controller, to review and manage the document control function ensuring regional documents are initiated, reviewed, revised, and filed and archived in a timely and compliant manner. Work within the company Region to improve the document control process through training another process improvements.

The Regional Quality Compliance Manager is RQA Market Cluster Lead for identified Zuellig Pharma Market(s), who is the contact point for Market QA, for supporting on quality related matters

Expectations of the Role:

Quality and technical guidance

• Maintain knowledge in applicable global regulatory guidelines and requirements worldwide such as basic EU and US GMPs (Good Manufacturing Practices) with ICH Q7/Q8/ Q9/ Q10, US FDA CFR 210/211 and 21 CFR Part 11 on Good Automated Manufacturing Practices (GAMP), PIC/S GMP, WHO Good Storage and Distribution Practices (GSDP)/ Model Requirement for Storage and Transport of Time and Temperature Sensitive Pharmaceutical Products (TTSPP), and Good Clinical Practice (GCP) – as they apply to ZP operations, and pay vigilant attention to current and developing trends in the regulatory expectations and enforcement and industry best practices to enable Zuellig Pharma to have assurance that its QMS reflects the latest cGMP (current Good Manufacturing Practices).
• Establish, implement and maintain Zuellig Pharma Regional Quality Management System (QMS) encompassing the company quality vision, mission and policies, relevant ISOs and GxP, industry best practices and trends, Clients’ and Customers’ requirements.
• Author of Regional QA Standards, Procedural Guidelines and Standard Operating Procedures in line with international standards and business process requirements on quality compliance areas.
• Provide training to Zuellig Pharma Market QA and Operations Team to ensure all processes and Market quality systems conform to Zuellig Pharma Regional QMS.
• Provide technical knowledge in the aspect of Quality Assurance (QA) to support Zuellig Pharma Markets in the application of problem-solving tools for the resolution of deviations/ quality issues (such as Ishikawa Diagram, 5 Why’s, and Pareto Diagram), application of statistical process techniques and process control (SPC) methods for analysing data to evaluate trends and patterns.
• Develop and maintain Regional Internal Quality Audit Team.
• Qualify Regional Quality Internal Auditors and 3rd party auditors from partner certification body and develop their competencies through training on Zuellig Pharma internal standards.
• Establish and maintain an Integrated Management System encompassing relevant ISO standards.
• Manage enterprise-wide certification of relevant ISO standards and security certifications, e.g. TAPA certification.
• To produce trends and analysis of CAPA and non-conformances for quality reviews and proposal of improvements, if necessary.

Operations support

• Provides support to Regional other functions in the implementation of the Zuellig Pharma Regional QMS.
• Support Markets in the preparation for due diligence audits of potential Clients and regional/global quality audits of current Clients through conduct of pre-audit and/ or participating in 3rd party audits by Clients and work on the resulting improvement programs related to Quality.
• Monitor quality compliance to ensure consistency with Zuellig Pharma Regional Standards and Guidelines through SOP compliance checks and surveillance audits.
• Maintain a failure analysis system to support troubleshooting, diagnosis and root cause analysis for critical, major deviations involving Clients and major customers, and ensures reporting and corrective actions are taken in a timely manner.

Documentation management

• As Document Controller, to review and manage the document control function ensuring regional documents are initiated, reviewed, revised, and filed and archived in a timely and compliant manner. Work within the company Region to improve the document control process through training another process improvements.
• Maintain the regional QA Share Point site(s).

Process Management

• Maintain, manage and coordinate quality assurance metrics for the region, including Client-specific metrics.
• Maintain Quality dashboards for visibility.
• Prepare presentation materials, including data analysis and Quality trends to identify improvement opportunities, for internal/ external meetings, such as Clients QBR, Clients QA Quarterly meeting and etc.
• Participate, review and support process improvement projects in Markets

Organizational liaison

• Prepare and present technical information to Clients and customers during audits and review meetings.
• Drive regular exchange of Quality-related information across Zuellig Pharma Markets through organizing or facilitating routine meetings, such as annual Regional Quality Summit, monthly QA meeting and quarterly QA townhall, where a platform to review Quality performance metrics, discuss issues and address challenges, share best practices and formulas for success.

Attributes Required:

Must-Have:

• Graduate of any Science or Engineering course (preferably Pharmacy, Chemistry, Chemical Engineering)
• Minimum five 5-8 years Quality Assurance experience, preferably in pharmaceutical manufacturing or distribution operations
• Experienced Quality Systems and GMP / GDP internal auditor
• Previous experience in the documentation, establishment, maintenance, and improvement of Quality Systems and Standards
• Knowledge in quality tools (basic statistics, process mapping, statistical process control)

Advantage to Have:

• Knowledge in Data Analytics
• Proficient in the use of MS Office applications
• Excellent communication and presentation skills
• Excellent English written and oral skill
• Experience in conducting technical training to groups of at least 10 people

Why Join Zuellig Pharma:

• We are committed to fostering an inclusive environment where our employees can learn, grow, and achieve shared success.
• We champion diversity, equity, and inclusion, ensuring every individual feels valued, respected, and treated fairly.
• As a leading multimarket healthcare solutions provider, we empower our employees gain comprehensive knowledge and expertise in the dynamic healthcare industry across the region.
• Enjoy the flexibility to effectively balance your work and personal life while taking charge of your career journey through our empowering growth opportunities.
• Our Total Rewards program is designed to support your overall well-being in every aspect