Primary responsibilities include oversight, leadership and management for the following activities: process validation, facility and utility qualification, equipment qualification, cleaning and sterilization validation, computer systems validation. These activities apply to all Regeneron clinical and commercial materials in accordance with regulatory expectations (FDA and EU/ROW) and Regeneron approved procedures. The ideal candidate will have the experience and the confidence to create and implement a vision for the validation strategy for a biopharmaceutical GMP manufacturing operation. Position will be expected to interface with Regulatory Authorities and will be expected to maintain an up to date awareness of regulatory issues related to validation.
Essential Duties and Responsibilities include, but are not limited to, the following:
'Create a clear vision to build a matrix organization to support the growing validation needs of the company (both internally and externally);
'Take the initiative to create and implement the site validation master plans;
'Establish, communicate and lead validation strategies;
'Develop systems to monitor and ensure validated state is maintained for key processes and systems;
'Remain knowledgeable and current on manufacturing processes, quality systems and relevant GMP related to validation;
'Maintain current knowledge of industry standards and regulatory expectations for Regeneron products and systems;
'Provide subject matter expertise for overall validation program during regulatory and partner inspections;
'Alert senior management to any validation issues related to GxP, product quality or patient safety immediately;
'Undertake projects to contribute to the improvement of systems and processes;
'Support regulatory filings and inquiries from authrorities;
'Identify gaps in systems and develop feasible plans for correction.
Experience And Required Skills :
'A broad knowledge of Pharmaceutical validation, regulatory compliance or quality engineering inclusive of cGMP, FDA regulations, and international guidelines and regulations (i.e., ICH, PIC/S);
'Excellent leadership, technical, management, problem solving and project management skills;
'Organizational and leadership skills to influence multiple functional areas;
'Ability to speak, present data and defend approaches in front of inspectors and other audiences;
'Ability to comprehend technical information related to facilities, utilities, equipment, processes, computer validation, scientific approaches and regulatory expectations;
'Strong interpersonal, written and oral communication skills and attention to detail;
'Knowledge of MS word, Excel, database management and statistical analysis;
'Knowledge of pharmaceutical/biotechnology process so as to be able to make appropriate decisions.
'Understanding and familiarity with FDA and Ex-US regulatory requirements, guidelines and recommendations.
'Requires BS in scientific discipline or related field.
'Minimum 10-15 years in GMP biopharmaceutical/pharmaceutical environment, with exhibited knowledge and proficiency of validation and quality activities.
'Experience in participating in regulatory inspections, presenting/defending departmental functions in audits or regulatory inspections.
We offer a competitive compensation and benefits package including stock incentives, 401k with company match, as well as the expected health and welfare benefits. Comprehensive relocation benefits are available, as required.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply to us today and find out what we mean when we say that, at Regeneron, we have an unwavering commitment to combining good science & good business.