Head of QA Operations, BDS

This is what you will do:

The Director for QA Operations for Bulk Drug Substance (BDS) has responsibility for all Quality Assurance Operations systems required to support commercial GMP manufacturing activities at the Alexion BDS facility in College Park Dublin. The position is responsible for cGMP and quality oversight of associated verification activities, technical transfer of manufacturing processes into the facility, operational readiness, process validation, new product introductions, commercial activities, filing reviews, inspection readiness and ongoing commercial product disposition.

This position is responsible for monitoring and supporting the quality performance at the Bulk Drug substance Site to all applicable standards for GMP.

The Director for QA Operations BDS executes the site QA activities at Alexion to ensure the safety, quality and efficacy of our products, thereby ensuring the availability of safe products for our Patients and assuring the security of the company’s business and global markets.

This role will establish, manage and support continuous improvement activities of all quality systems to ensure compliance, achievement of site goals / objectives and Inspection readiness. The Director, QA Site Operations may lead investigations, resolve potential quality issues, recommend and implement changes as necessary.

You will be responsible for

• Foster, lead and embed a strong culture of Quality in the BDS facility.
• Lead the preparation and be the site representative for Health Authority inspections of BDS.
• Ensure site wide implementation of Quality Systems to GXP and Alexion requirements.
• Ensure quality systems are realized to the highest quality standards attainable for all activities conducted by the company, supporting Product Quality Review, quality management review and annual report completion on time.
• Managing a QA team to provide quality and cGMP input and oversight for all BDS activities, BDS manufacturing operations and New Product Introductions to maintain compliance with expected regulatory regulations and support on time disposition.
• Development, mentoring and coaching of all Quality colleagues supporting the BDS manufacturing operation.
• Developing a lean thinking mindset within the Quality Operations with a strong focus on eliminating waste, continuous improvement and sustainability
• Lead a cross functional team in the compliance requirements of change management, risk management, deviation management and verification activities associated with new products and ongoing activities of the BDS facility.
• Represent Quality Assurance at various project and technical meetings, as needed.
• Having a proactive collaborative relationship with Manufacturing, Technical Services, CQV, Facilities, and Quality Control to resolve open issues resulting from record reviews, on-the-floor. Contribute to the design and implementation of best practice quality improvement programs.
• Interacting professionally with company management, internal departments and other sites to effectively implement and maintain Quality Systems.
• Review of manufacturing and support records to certify compliance with specifications and procedures, ensuring timely resolution of quality system issues and timely disposition of product.
•  Reviewing and assessing deviations; including performing risk assessments, participating in root cause analysis investigations, tracking, follow-up, and reporting/trending.
• Reviewing and approval of Corrective and Preventative Actions (CAPA), including tracking, follow-up, and evaluating CAPA effectiveness.
• Lead and manage the QA responsibilities in Manufacturing Operations including QA responsibilities in Work Instructions, competencies, SOP’s, OJT’s, batch records, contamination control and multi-product strategies.
• Lead and manage the QA responsibilities in Technical Services and Technical Transfer, including QA oversight of Process Descriptions, associated Plans and Engineering and Demonstration Batches as required. Oversight of Process Validation, Filter Validation, PCM Assessments, Hold Studies, Development Studies, Leachable and Extractable Assessment, Risk Assessments, Gap Analysis and Regulatory Filing.
• Lead and manage the QA responsibilities for cell banks, material, vendor Management for BDS and QA disposition of applicable materials and cell banks.
• Lead and manage the QA responsibilities for the Warehouse including the receipt, sampling and dispensing of materials and the associated material movement strategy.
• Provide QA oversight of the cleaning and sanitization program for the BDS facility.
• Provide QA leadership and oversight of the development of BDS related IT systems including SAP, LIMS, electronic batch records, MES.
• Provide QA support to the QC Microbiology including associated EM Risk Assessments and associated sampling plans, review and approval of associated studies (growth promotion, recovery studies, sanitisation studies), method validation and review and approval of EM related deviations for BDS.
• Lead and manage batch disposition and confirmation of QP partial manufacturing of BDS as per the agreed cycle times.
• Provide QA and QP support to Regulatory for Regulatory submissions and QP declarations.

You will need to have:

• Minimum of 10 to 15 years’ experience in cGMP Quality environment and 5 years in a relevant QA or Technical managerial role.
• Thorough knowledge of cGMPs, GLPs, GDPs and regulatory requirements
• Strong awareness and understanding of pharmaceutical and biotechnology business, especially with regards to quality and regulatory requirements
• Demonstrated success establishing and managing a QA organization with multi-level reporting structure and providing support to 24/7 manufacturing operations.
• Excellent people management, problem solving, decision-making skills and the ability to manage a broad portfolio of activities in an environment where priorities can change.
• Ability to successfully lead a Quality Organisation and partner with Operations.
• Strong leadership, communication and interpersonal skills with a lean-thinking mindset.

We would prefer for you to have:

• BSc/BA degree in chemistry, biological science or related field.
• 10 or more years of cGMP experience preferred. Consideration will be given to other relevant experience and education

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.