Quality Lead

MSD

Dunboyne

The QA Lead (Associate Director Level) is a key leadership position that will provide QA direction for  New Product Introduction (NPI) as a commercialisation site. The overall responsibility for this role will be to manage, plan and direct QA on site by supporting – QA Operations, Disposition and QA Systems including, QRM and Internal Auditing to ensure the highest quality support to Operations, Engineering, MS&T, QC and Plan and Procure teams, while ensuring compliance with cGMP and safety regulations. This is a critical role within the Site leadership organisation to help create value for our patients. This role will be part of our QA Systems and QA Operations & Disposition Self -Directed work teams in our new state of the art single use multi-product biotech facility in Dunboyne, County Meath, Ireland.  This facility will manufacture antibody-based therapies for our Patients, a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide.  The organisational structure at the site will be based on self-directed work teams where decisions will be made at the level where the data exists.  The QA Lead will work across the site self-directed work teams and hub teams to identify and resolve issues in order to allow the site to achieve our Governance Pillars in PSQDC.   This role will also provide Quality Assurance (QA) oversight to the qualification/validation and technical transfers and will be partially responsible for budget management in the facility. What you will do: Bring your energy, knowledge, and innovation to: Strategic QA oversight and leadership at the Dunboyne Biologics start-up facility to meet functional and site goals and objectives. Responsible for QA at the Dunboyne site (QA System, QA Operations, Disposition, Quality Risk Management (QRM) and Permanent Inspection Readiness (PIR)). Hire, develop, lead and coach the QA team and drive a high-performance organizational culture that accommodates rapid growth and highly dynamic expectations, ensuring attainment of site operational and development goals. Responsible for adhering to domestic and international GMP regulations, cGMP’s, company policies, leadership behaviours, performance and budget management. Responsible for the management of site QMS (Change control, Document Management, SQM, Deviation Management & CAPAs, PIR, QRM, Customer Complaints, Returns & Recalls and APQRs. Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals and commercial operations at the facility. Responsible for the management of batch record review, discrepancy reporting, investigations and CAPAs associated with all areas of operations. Support the site Lead Auditor in the delivering the PIR program and managing Health Authority Inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions. Coordinate with peer internal Quality Groups to ensure on-time disposition of commercial drug substance material. Engage the appropriate company’s centres of excellence to ensure the very best of the company is brought to site to build excellence into our QA systems and processes. Provides guidance to all relevant quality related events and direction to develop the area(s) technical and compliance capability along with long term strategic planning. Leads the QA team in meeting targeted site and GBSO objectives, ensuring objectives are aligned, translated to all and visually managed to drive delivery. Sustained performance through lean leadership, robust learning and development planning, organisation talent reviews and communication planning. BuiIds partnerships within the Quality leadership team (QLT) to create and sustain a culture that demonstrates excellence in quality and continuous improvement. Creates an environment of right first time in everything that we do through a focus on principles of lean, including simplification, standard work, visual management and a learning organisation. Responsible for individual goal setting, ongoing performance reviews and development planning for direct reports and function. Responsible for timely updates of site achievements and challenges. A collaborative approach, working cross-functionally on resolving obstacles to maintain a highly effective and productive functional group. Role model the behaviours that creates a culture of respect and dignity. Ensure Safety First Quality always values are engrained in QA. What skills you will need: Minimum of level 8 Bachelor’s degree in a technical discipline (e.g. biochemistry, chemistry, microbiology) or equivalent. At least 12 years’ experience in the biotechnology and/or pharmaceutical industry (preferably both. Proven leader capability in developing people and teams with at least 8 years of management experience. The successful candidate should have the knowledge, experience and leadership style to lead the QA team and support the wider Quality team through coaching, strategy build and execution to ensure right first-time operation and approval of the sites QA capabilities. Proven ability around working cross functionally, focusing on meeting and tracking to schedules and embracing an interdependent work culture. Experience working in a GMP/regulated environment. Organisation Skills – Ability to manage multiple priorities and know when to escalate issues for resolution. As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs. As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process. We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world. Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model. So, if you are ready to: Invent solutions to meet unmet healthcare needs, please apply today.

879 days ago