Job Opportunity

Job Opportunity

QA Drug Substance Operations Group Leader

QA Drug Substance Operations Group Leader

Ireland Posted 2024-07-29

QA Drug Substance (DS) Operations Group Leader - 12month FTC

The QA Drug Substance Operations Group Leader will play a pivotal role in the QA Department, with overall responsibility for ensuring timely and efficient release of biological drug substance batches including leading the preparation and review of batch disposition documentation to support Qualified Person (QP) release. This role is being offered as a 12month Fixed Term Contract.

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 600 customers worldwide, including the top 20 biopharmaceutical companies.

Department Description

As QA Drug Substance Operations Group Leader, you’ll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. This is a 12month FTC Contract. In this role you’ll be reporting to the QA Drug Substance Operations Lead.

Your Responsibilities

In this role, you will:

Lead the QA DS Release team to ensure timely and efficient release of biological drug substance batches.
Develop, implement, and monitor the quality systems relating to warehouse, SCM and manufacturing and batch disposition operations.
Develop/build a world-class Biologics QA DS team including planning, recruiting/hiring, coaching, mentoring and training.
Oversee the compilation of deviations, change controls, QC data & batch production record reports to support batch disposition.
Ensure that environmental and utilities monitoring data is provided to QPs at agreed frequency to support batch disposition activities.
Ensure that Product Quality Review(s) and stability data are provided to QPs to support batch disposition activities.
Oversee the QA review of batch production records, including liaising with other departments, such as Manufacturing Operations, to resolve any discrepancies noted during the review.
Liaise with Online QA DS Manufacture team to identify priorities with respect to deviations and other non-conformances in support of batch disposition activities.
Liaise with QA for QC team and QC to identify priorities with respect to QC release data, OOSs, OOTs and stability data in support of batch disposition activities.
Liaise with Supply Chain Management and project planning teams to identify priorities with respect to batch release and shipment.
Liaise with Client, either directly or through a Client Manager, in relation to batch disposition activities.
Support the investigation of quality related deviations and supports execution of corrective and preventative actions and related documents to ensure compliance is achieved and maintained.
Collate batch disposition metrics and KPIs to monitor batch disposition process performance.
Identify continuous improvement opportunities to ensure batch disposition processes are efficient and remain in a constant state of compliance.
Prepare, review and approves SOPs relating to QA DS Release.
Participate in cross-functional teams and projects, as required.
Provide and facilitates training for direct reports.
Manage individual direct reports’ performance through formal and informal performance management processes.
May be involved in the preparation of Product Quality Review(s).
May be required to provide support to QPs, including ensuring that QP registers are maintained up-to-date and checking that tasks as required in section 1.7 of Annex 16 “Certification by a Qualified Person and Batch Release” are being conducted by the company as per SOPs.
Perform all duties in accordance with GMP requirements, SOPs and controlled documents
Will act as a role model for the QA function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture.

Your Profile

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

Education:

A Bachelor’s degree in a technical discipline (e.g., biochemistry, chemistry, engineering) would be an advantage.

Knowledge/Experience:

Required:

8 plus years’ experience in the biotechnology and/or pharmaceutical industries within a Quality role, preferably in QA or similar.
Ideally, experienced in establishing a QA DS Release team in a ‘greenfield’ context of similar size and scale.
Ability to prepare for regulatory and customer GMP inspections of the site and participate in GMP internal audits and self-inspections.
Demonstrated knowledge of Quality Management System and continuous/process improvement tools.

Personal skills:

Strong knowledge of cGxP requirements and regulations.
Adaptable, with ability to multi-task and handle tasks with competing priorities effectively to deliver site priorities.
Demonstrated collaboration, negotiation & conflict resolution skills with a teamwork mindset.
Excellent communication skills (written and oral).
Analytical, problem solving & root-cause analysis skills.
Ability to challenge the status quo with a continuous improvement mindset.
Excellent attention to detail.

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 - 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.wuxibiologicscareers.ie/ or contact us via talentacquisition@wuxibiologics.com

WuXi Biologics is an equal opportunities employer.

Apply now