Change Control & Deviation Management Lead

Job Description

JOB DESCRIPTION & SPECIFIC OBJECTIVES

The Senior (Sr) Specialist, Change Control and Deviation Management role will be involved in implementation and maintenance of Change Control and Deviation Management procedures at our Company's Wilmington Biotech.  The Sr Specialist will ensure the processes conform to our Company’s policies and comply with Current Good Manufacturing Practices (CGMPs), Health Agency regulations, and all other applicable governing regulations, with the mission and ambition to manufacture breakthrough medicines for patients around the world.

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Close collaboration with high-performance talent from our Company’s global team, the site team, and the biotechnology industry to develop and execute these Quality Management Systems and processes will be key.  The successful candidate will be an individual and team member who supports building the future of our Company’s antibody drug conjugates and high potent compounds through a Quality culture that delivers unconstrained supply, that is ‘Right First Time’, to patients worldwide.

As necessary and when applicable, providing training and guidance on the interpretation and implementation of our Company's policies and regulatory requirements will also be key priorities for the Sr Specialist. Throughout development of the new Wilmington Biotech facility, the successful candidate will focus on the deployment and maintenance of Change Control and Deviation Management processes.

POSITION RESPONSIBILITIES

With energy and enthusiasm, the Change Control and Deviation Management Sr Specialist will:

• Establish and maintain robust systems for Change Control and Deviation Management, in alignment with the our Manufacturing Division Quality Management System (QMS), for the Wilmington Biotech site

• Manage and monitor the processes for the site, including but not limited to, providing guidance and support to Change/Deviation Owners, review the Change Management System dashboard, escalate Changes/Deviations with potential risk(s) accordingly, track and trend Deviations

• Serve as site Subject Matter Expert (SME) for the deviation management and change control system.

• Will monitor performance of the site change control and deviation management system, providing structure for performance monitoring across the site teams.

• Support compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as regulatory requirements for Change Control and Deviation Management

• Provide Change Control and Deviation Management information necessary for the Annual Product Quality Review (APQR), as applicable and appropriate

• Responsible for provision of Change Control and Deviation Management metrics in relation to the Quality Council process

• Advocate continuous improvement in the Change Control and Deviation Management systems

• Serve as site topic lead for deviation management and change control and provide training to end users

• Take part in the Change Control and Deviation Management communities of practice/knowledge networks

• Support external CGMP audits (e.g., Regulatory Authorities, Global Quality) as SME in Change Control and Deviation Management

• Knowledge of US and European GMP guidelines, ICH, and other international regulatory requirements, as applicable to the site

REPORTING STRUCTURE

This position will report into the Site Quality Management Systems (QMS) Lead.

QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS

General

This role requires a seasoned individual with a minimum of 5 years’ experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations. 

A self-starter and results-focused, the successful candidate will have contemporary knowledge of relevant CGMPs, regulations, and current industry trends.

Technical

• Must have at least 1 year of operational experience

• Must have experience in Change Control and Deviation Management

People

• Demonstrated knowledge of global health authority regulations and quality and compliance requirements with the ability to effectively communicate these requirements

• Knowledgeable in Industry Best Practices for quality and compliance related topics

• Strong collaboration and cross-functional skills to support continuous improvement, promote knowledge sharing, and implement best practices across the site and Compliance functions on global and local levels

• Strong verbal and written communication skills, as well as proj