This Quality Assurance Manager job is with one of the most renowned global pharmaceutical, medical device and consumer health organisations located in the UK. The organisation is a top 10 pharma company and employs over 100,000 professionals worldwide.
Under the minimal direction of the Director, Quality Planning & Strategy (QP&S), develops and maintains integrated quality plans for assigned compound development programs. This role supports the company Quality Management System implementation and inspection readiness within Pharma R&D.
- Develop and manage integrated quality plans (IQPs) to support Pharma R&D business-critical compound development activities (such as health authority submissions to support new molecular entities or new indications for use) to ensure coordinated quality risk review and mitigation.
- Work with clinical team members and risk owners across R&D functions to develop effective risk mitigation plans to control quality risks identified in the IQP
- Provide input to trial and compound oversight and quality strategies to ensure that issues and quality risks are identified in the IQP and mitigated early, and that predefined risk mitigation plans in the IQP are executed in a timely fashion and are effective in mitigating the risk to an acceptable level.
- May execute quality oversight activities as per IQP plan.
- Lead quality working groups (QWGs) to define and refine the IQP. Organize and lead meetings of the QWG to periodically assess quality metrics to determine if risks are adequately defined and controlled under the IQP. Communicate outcomes of QWG meetings to relevant stakeholders, including senior management.
- Lead or assist in the early identification, escalation, and resolution of significant quality issues pose a significant risk to achievement of core company objectives.
- In collaboration with Regulatory Compliance, lead inspection readiness activities to support health authority submissions.
- Develop and execute pre-inspection readiness activities for internal R&D and external parties that contribute to regulatory submissions.
- May Manage Site Inspections as well as Sponsor Monitor Inspections outside the three major inspectorates (FDA, EMA, MHRA). Support inspections managed by Regulatory Compliance.
- Leverage quality analytics data and contextualize key quality insights to primary stakeholders and provide quality consultancy. Consult/Collaborate with other BRQC functions to harness the single point of contact model to our business partners
- May Manage the utilization of BRQC resources in the IQP. Ensures that BRQC activities are integrated to maximize BRQC support of submission readiness.
- Consults with appropriate business partners and peers within BRQC to provide guidance or review and approve Corrective and Preventative Action Plans (Self Identified, Inspection) - may also develop Corrective and Preventative Action Plans.
- Provides regular status reports to BioResearch Quality & Compliance (BRQC) management.
Education, Skills and Experience:
- A minimum of a Bachelor's degree is required. An advanced degree (MD, PhD, MSc, or PharmD) is preferred.
- A minimum of 8 years of experience in a Quality, Compliance, and/or R&D environment is required.
- Knowledge of the global drug development process and current GxP regulations is required, including experience in GCP (Good Clinical Practice)
- Experience in the pharmaceutical industry is preferred.
- Experience in and/or knowledge of risk management in a GCP regulated industry is required.
- Industry recognized certifications are preferred.
- Experience with regulatory submissions (NDA, BLA) is required
- Understanding of the content and structure regarding Common Technical Documents (CTD) is preferred.
- Knowledge of FDA/ICH and country-specific regulations and guidelines is required.
- The role may require up to 25% travel.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nick Dietz on +44 203 3193 033 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.