Job Opportunity

Job Opportunity

QC Raw Materials & Compendial Lead, Associate Director

QC Raw Materials & Compendial Lead, Associate Director

Ireland Posted 2023-07-19

QC Raw Materials and Compendial Lead, Associate Director

As QC Raw Materials and Compendial Lead, Associate Director you will be responsible for ensuring the highest standards of professional regulatory adherence excellence and quality within the business, with overall responsibility for the management of QC instruments/equipment and analytical test methods for raw materials testing, managing raw materials specifications and raw materials release, sampling of raw materials for QC testing and managing raw materials regulatory retain samples, leading product compendial testing, and other project support functions. Working closely with senior leaders in all areas of the business, this position will play an integral role in the development of the local QC strategy/business planning, aligned closely with the global QC function.

Organization Description

WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world's 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 10,000 people and provide services to more than 200 customers worldwide, including 13 of the top 20 biopharmaceutical companies.

Department Description

As QC Raw Materials and Compendial Lead, Associate Director you’ll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives.

In this role you’ll be reporting to the QC Director.

Your Responsibilities

Key member of the QC leadership team for WuXi Biologics Ireland. Will play an integral role in the strategy and business planning processes, ensuring cross functional collaboration and leadership execution.
Work closely with all senior leaders to ensure work practises and targets are achieved in line with the business targets and objectives.
The role will require extensive liaison with counterparts and business leaders in WuXi Biologics corporate to include the highest level of professional representation of the local site QC organisation.
From a QC functional capacity support the design, construction, and commissioning of the new facility for the production of drug substance.
Develop/build a world-class Biologics QC Raw Materials and Compendial testing team, including planning, recruiting/hiring, coaching/mentoring, and training for approximately 8-15 total headcount.
Responsible for raw materials and compendial routine testing, method verification, and method transfer.
Management of raw materials and compendial testing QC instruments and equipment
Raw materials sample management, including sampling, sample log-in and disposition, as well as routine inventory checks of regulatory retention samples.
Author technical documents, including relevant SOPs, testing protocols and reports, raw materials specifications, and raw materials expiries.
Represent Raw Materials and Compendial testing teams in regulatory inspections and client and internal audits.
Serve as a technical lead in applicable investigations, deviations, change controls, and CAPAs.
Communicate, collaborate, and cooperate with QC functional teams and other departments to support lab start-up and routine operations.
Ensure the tasks associated with the start-up and routine operations applicable to the role are carried out in a safe manner.

Your Profile

The ideal candidate for this position, will have the following:

Education

University degree in related science/quality discipline required.
Ph.D. with 5+ years of experience, or Masters with 7+ years of experience in Chemistry, Analytical Chemistry, Biochemistry, Biology, Molecular Biology, Engineering, IT, or other related field, desired.

Knowledge/Experience

15+ years’ experience working within Quality Control/GMP environment with a well-rounded exposure to all areas in this field and significant experience with raw materials and compendial testing.
Experience with Microsoft Word, Excel, Powerpoint, Visio, and Project Management/supervision of personnel with particular attention to schedules and shifting priorities.

Preferred:

Previous experience with regulatory inspections and internal/customer audits is strongly preferred.
Previous experience working in a CMO is a plus.

Personal skills

Excellent interpersonal, verbal, and written communication skills.
Able to think critically and demonstrate troubleshooting and problem-solving skills.
Self-starter and self-motivated; organized with good attention to detail.
Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities.
Results oriented, with the ability to manage multiple priorities in a short period of time.

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 can 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 mission - Any drug can be made, and any disease can be treated - don’t 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 https://www.wuxibiologics.com/join-us/

WuXi Biologics is an equal opportunities employer.

Apply now