ProClinical is advertising a vacancy for an Associate Director Quality Assurance position with a global biopharmaceutical company. The organisation focuses on developing treatments in the fields of oncology, cardiovascular & metabolic disease (CVMD) and respiratory fields, as well as actively participating in the fields of autoimmunity, neuroscience, and infection. This position offers an exciting opportunity to work with an innovative company whose medicines are used by millions of patients worldwide.
The Associate Director Quality Assurance Pharmacovigilance (PV) will plan, lead, conduct, and report end-to-end audit activities for Science Unit GxP risk-based audit program and will be responsible for delivery of proactive PV inspection support and management. They will also be responsible for management of significant CAPAs related to audit and/or inspection findings in collaboration with functions owning the issues.
Job Responsibilities:
- You will plan, lead, conduct and report audits in assigned GxP areas, and types e.g. investigator site audit, system or process audits and vendor audits.
- You will participate in and may lead directed (For Cause) audits.
- You will work with contract personnel or consultants to prepare, conduct and report outsourced audits.
- You will also support Due Diligence activities as assigned.
- You will collaborate with Quality Assurance Lead to manage and prepare for regulatory inspections, including providing pre- inspection training to the organisation as needed.
- You will provide QA oversight and/or management of regulatory GxP inspections.
- You will assess need for, and assist in development of CAPA plans, approve and monitor plans to completion.
- You will be involved and may lead the development and/or revision of QA processes and procedures including SOPs and risk assessment tools.
- You will ensure own tasks are performed to current practices and in accordance with company standards and policies.
- You will promote a culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits.
- You will communicate effectively with QA and business stakeholders.
- You will maintain comprehensive knowledge of relevant industry information affecting compliance arena.
- You will maintain knowledge and compliance to relevant regulation, policies, standards, SOPs and guidelines.
- You will lead training for colleagues and business stakeholders as required.
- Some travel is expected.
- You will provide responsive and proactive quality and compliance advice to defined stakeholders, effectively influence assigned area by being relevant GxP/quality system.
Skills and Requirements:
- Degree level education.
- Experience in pharmaceuticals or a related industry.
- Excellent analytical, written and oral communications skills.
- Fluent in English.
- Regulatory Environment Insight.
- Audits & Inspection Knowledge.
- Process Management & Continuous Improvement.
- Quality Management.
- Audit expertise.
- Experience supporting regulatory authority inspections.
- Project management.
- Key Account management.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Katty Maia at + 442038543317 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.
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