Senior QC Systems Specialist

As Senior QC Systems Specialist you will be responsible for the successful management and execution of all the IS activities supporting Quality and Laboratory information systems and will also lead the implementation of new Quality and Laboratory information systems and management of the associated team of reportees.

The ideal candidate will have strong LAN Windows Server VMware Citrix AD Domain Controls IAM and Security experience.

Organisation Description

WuXi Biologics is a premier provider of biologics services (from discovery to commercialisation) with global customers in the biopharmaceutical and healthcare industries. Were one of the worlds top three contract development and manufacturing companies for biopharmaceuticals we provide our clients with a world-leading open access technology platform. We enable our clients to research develop and manufacture drugs from the concept phase to commercial manufacturing.

Our mission is to accelerate and transform discovery development and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China the US the EU and Asia. We currently employ over 10000 people and provide services to more than 600 customers worldwide including the top 20 biopharmaceutical companies.

Department Description

As Senior QC Systems Specialist youll be joining an organization where people of all backgrounds and experiences are respected and where we work together focused on changing this role youll be reporting to the QC Equipment and Systems Senior Manager.

Your Responsibilities

• Act as the Senior Specialist for Information Systems supporting Quality and Laboratory information equipment.
• Ownership and administration of the IS aspects of Lab equipment including analytical equipment platform architecture system ownership and lifecycle management.
• Ensure that all Lab IT systems and Benchtop Analytical Equipment meet 21 CFR 11 and EU Annex 11 compliance requirements.
• Lead and manage a team of QC System Specialists where applicable.
• Provide effective communication and play a leading role in project management interaction with internal and external clients such as Quality Assurance Regulatory Affairs and QC analytical personnel.
• Lead and support system improvements development of detailed specification and standard operating procedures.
• Ensure that all associated protocols/reports are completed reviewed and approved within agreed timelines in order to secure reliable consistent & compliant operation of all Lab EquipmentInstruments to meet the GMP and business requirements of the labs.
• Lead technical root cause analysis incident investigations and troubleshooting issues related to the Quality and Laboratory information systems.
• Experience in change control non-conformance corrective and preventative actions and validation practices.
• Support new technology introductions by performing IS assessments and implementing IS system configuration changes.
• Participate in Computer Software Validations.
• Solving complex problems project management lifecycle management and operational excellence.
• Develop manage and support GxP change control requests per established SOPs and processes.
• Support cyber security initiatives tracking and scheduling the deployment of OS Patches
• Day to day vendor management and contract negotiations with focus on Quality and/or Laboratory information systems suppliers.
• Support a safe working environment by complying with all pertinent environmental health/safety practice rules and regulations.
• Will be flexible to take on additional tasks and responsibilities at the discretion of the Associate Director of QC Operations.
• Potential candidates may be required to carry out additional job functions that are not described in this job description but will be associated with the role.
• Work with the QC QA and CSV teams to support the enhancement and optimisation of IT systems to meet end user requirements.

Requirements

Technical Competencies

• Experience with LIMS and Empower is desirable.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals; ICH and GMP guidelines desirable in relation to Lab IT requirements.
• Experience with regulatory/customer audits is desirable.

Experience

• 3 years experience supporting Quality and/or Laboratory information systems in the biotechnology or pharmaceutical industries or has worked in similar Laboratory environments and has gained expertise in the use of Laboratory information systems
• Experience with the following systems would be an advantage: Chromatography (Empower Waters) Lab Data Archival (Nugenesis Waters) Electronic Methods Execution/Electronic Lab Notebook (SmartLab Biovia) LIMS (Sample Manager - ThermoFisher) Environmental Monitoring (MODA)
• Experience of the following: Windows ServerWindows NT 98 XP Win 7 MS Active Directory DNS DHCP DFS MS Office 2003/2010/2013 MS Office Communicator MS Lync 2010/2013 MS SharePoint 2007/2010 LAN/WAN/VPN.
• Technical leadership skills with a strong ability to support continuous improvement addition to leadership capabilities candidates must have a working knowledge of the GAMP software development lifecycle.
• Experience with facility start-up projects (brown field or green field) is desirable.
• Experience in Training of personnel.
• Previous experience in a Quality Control/GMP environment is required.
• Experience with Microsoft Word Excel Powerpoint Visio and Project is required.
• Management/supervision of personnel with particular attention to schedules and shifting priorities is desirable.

Knowledge

• Knowledge of analytical testing in support of biopharmaceutical manufacturing is preferred but not required.
• Thorough knowledge of Pharmaceutical Industry Regulations (cGMP/cGLP OSHA EPA/EQB) required. Strong working knowledge of 21 CFR 11 compliance requirements as they relate to Lab IT systems.
• Ability to master with minimal support new IS technologies and processes
• Strong knowledge of databases reporting and analytic systems
• Ability to ensure compliance with practices policies procedures legal requirements and site objectives and goals.

Qualifications

• University degree in related science/IT/quality discipline or relevant vocational qualifications required.

Behavioural Competencies

• Strong leadership competencies with demonstrated management skills.
• Excellent communication interpersonal and presentation skills.
• Ability to think critically and demonstrate troubleshooting and problem-solving skills.
• Independent self-motivated organized able to multi-task in project environments and skilled in communication and collaboration.
• Comfortable in a fast-paced working environment and able to adjust workload based upon changing priorities.
• Collaborative and inclusive approach to work and your colleagues.
• Flexible approach to work and a positive attitude will be a good fit within the team dynamic.
• Engage cross functionally in conjunction with a site-based team.
• Autonomous and a self-starter who will use their initiative to drive actions forward.
• Demonstrate strong ethics in adhering to company procedures and policies regulatory standards and our customers expectations
• Shift work and business travel may be required for this position as directed by departmental management.

As we extend our global reach we need colleagues interested in change in challenge and in building a new future together. Reach beyond yourself and discover your true potential!

If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our vision - Any drug can be made and any disease can be treated - dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential.

Apply now!

Would you like to know more before you apply Please visit us at or contact us via

WuXi Biologics is an equal opportunities employer.