Associate Director QA Processes and Systems - REMOTE
Proclinical is seeking an Associate Director QA Processes and Systems for a cutting-edge biotech company. This role is a permanent, full-time position with the opportunity to work remotely in the US.
The Associate Director QA Processes and Systems supports the establishment and implementation of a proactive, risk-based Quality Management System (QMS) for the company functions overseen by the Global Development Quality Assurance (GDQA) organization in alignment with company policies and procedures and international regulations and guidelines.
Must be eligible to work in the US.
- Supports the setup and maintenance of the Global Development Quality Management System (clinical QMS).
- Ensures the implementation and maintenance of processes for Procedural Document Management, Training/Learning Management System and Management of GCP Deviations, including Serious Breaches.
- Supports the implementation and maintenance of processes for Clinical Risk Management, Health Authority Inspection Management and Regulatory Intelligence.
- Supports cross-functional enterprise level projects, systems & teams and act as a credible and respected spokesperson on matters pertaining to QMS and management of procedural documents, training and deviations.
- Assumes responsibility for performance results and establish & monitor Quality Objectives and Metrics.
- Promotes a pro-active risk-based Quality culture by implementing Quality by Design principles, partnering with applicable stakeholders to prevent/manage issues and support the organization objectives and goals
Skills and Requirements:
- Degree in life sciences, pharmacy or equivalent (university degree or medical profession). Preferably advanced degree incl. PhD/MD.
- Completed relevant university education & broad and/or deep, specialized, task-specific expertise and skills.
- At least 7 years of experience in a Good Clinical Practice (GCP) Environment in the Pharmaceutical, biotechnology or CRO Industry, preferably in Quality-related functions.
- Solid understanding of Quality, GCP principles and their impact on company's development and business.
- In depth expertise in worldwide regulations and guidelines (including ICH, FDA, EMA) related to clinical trial development and post approval of medicinal products.
- Experience in Quality Assurance (QA) functions in Clinical Development such as quality systems or quality/audit/inspection/risk management.
- Fluent in English (written and spoken).
- Ability to conduct independent analysis, influence stakeholders across the matrix and manage competing priorities.
- Computer literacy, knowledge in the use of electronic quality management systems and ability to function independently within an environment that relies heavily on technology and computer systems.
If you are having difficulty in applying or if you have any questions, please contact Julia Friedrich at +(1) 617-830-1584 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.