Associate Director, QA Processes and Systems - REMOTE

Proclinical is seeking a remote Associate Director, QA Processes and Systems for a leading biotech company.

Must be eligible to work or be a citizen in the US.

Job Responsibility:

• 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.
• Supports the development and implementation of the Clinical Quality Management System framework.
• Ensures the implementation and maintenance of processes/systems for:
• Procedural Document Management - through the evaluation, creation, and maintenance of Procedural Documents applicable to Global Development Organization (GDO), QA and Clinical Laboratories, in line with company policies, applicable regulations, guidelines (e.g., GCP, GVP, GCLP) and critical business processes.
• Training/Learning Management System - including the assessment of clinical training matrix/groups per function/role (existing vs. required), implementation of training plans in line with the clinical QMS framework and tracking of compliance with training plans on applicable GxP standards and procedural documents.
• Management of GCP Deviations (GCP non-conformances, Serious Breaches, etc.), and management of related Corrective Action and Preventive Action (CAPA) plans.
• Supports the implementation and maintenance of processes for:
• Clinical Risk Management in partnership with key stakeholders such as Clinical QA Compliance and Clinical Operations functions.
• Health Authority Inspection Management and management of related Corrective Action and Preventive Action (CAPA) plans.
• Regulatory Intelligence system/process in partnership with applicable stakeholders to ensure awareness, evaluation and implementation of applicable legislations and regulatory requirements.
• Establish & monitor Quality objectives and metrics.
• Participates in cross-functional meetings/projects/initiatives, providing QA & GCP expertise and guidance.
• Builds and maintains strong relationships with key stakeholders to execute the company & department strategy, implement pro-active and risk-based quality approaches, implement Quality by Design principles, and achieve company objectives.

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 Christina Chung at (+1) 857-233-9215 or c.chung@proclinical.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.

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