Associate Director, Quality Assurance (Quality Risk Management)

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: Serve as global process owner of the end to end Global Quality Risk Management System across global functions at Industrial Operations and Product Supply (IOPS) sites, including combination product development, Drug substance and drug product clinical and commercial production. Ensure adoption of Risk Management principals is applied across disciplines and lifecycle through close collaboration with Senior Leaders and key stakeholders.

This individual will be hands-on subject matter expert and be responsible for having oversight of Quality Risk Management Governance process globally at Regeneron IOPs sites, ensuring compliance with global regulations and standards set forth by governing regulatory and accrediting agencies. They will also support other departments and project teams in meeting quality and business objectives as they relate to GxP risk management.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Provide leadership to the Global Quality Risk Management team. Manage and continually improve Quality Risk Management (QRM) system supporting groups identified in the summary.

• Formulate risk management strategies, principles, methods and tools, and document in appropriate Regeneron policies, procedures, and reports.

• Educate and train staff (cross sites) in quality risk management principles and practices and act as a subject matter expert and resource for QRM matters.

• Manage and lead data driven risk assessments (risk identification, analysis and ranking).

• Responsible to develop and manage data analysis and statistical tools used to support quality risk management activities.

• Oversee QRM program to ensure risk assessments are conducted as required frequencies and manage the overall process, tasks, and communications

• Communicate the outcome from quality risk management activities to all business partners

• Work with the management team to integrate quality risk management concepts and philosophies into the overall Quality System.

• Function as a fully integrated member of the Quality Assurance management team, advising on all QRM matters within the IOPS organisation, as well as being the primary interface with customers

• Represent Regeneron's approach to Quality Risk Management during regulatory inspections and partner audits. Serve as the Subject Matter Expert in Risk Management Governance processes

• Author/revise Risk Management policies and procedures to align with current business and regulatory requirements. In addition, create, implement, and manage Quality Metrics Program and Management Review governance policies and procedures

• Create, facilitate and chair standing cross-functional QRM Escalation Council where all GxP product and process high risk items are escalated, discussed, mitigated, and documented in accordance to written procedures and standards

• Working with cross-functional teams, create, maintain and publish a monthly Quality Performance Metrics/Key Performance Indicators.

• Create, implement, and facilitate standing Management Review meetings where Quality KPI's and other risks are escalated, communicated, and documented

• Provide ongoing collaboration, engagement, and education to cross-functional teams members in the application and compliance of risk assessment and mitigation processes

• Partner with cross-functional colleagues to meet compliance requirements and business needs

• Identify and implement continuous improvement projects related to Quality Risk Management, Quality Metrics, and Management Reviews

Knowledge Skills & Abilities:

• Must possess effective and positive leadership skills including effective team work and collaboration, engagement, negotiation, impact change, escalation, transparent, and identifying issues and solutions

• Ability to handle multiple projects simultaneously and to prioritize tasks in a dynamic environment

• Ability to speak effectively and communicate directly with all levels of personnel in a positive and collaborative manner

• Must possess excellent communication skills, both verbal and written

• Strong self-motivation as well as the ability to work independently, and in a team environment with minimum supervision

• Ability to use critical thinking, resolve issues, and deal with a variety of variables in situations where general standardization does not yet exist

• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form

• Strong follow-up and organizational skills

• Ability to identify situations which will require management intervention for resolution. Ability to assess regulatory/compliance risk identify areas of improvement and propose practical solutions.

• Must possess proficient knowledge of Microsoft Word, Excel, Power Point, and other systems such as, SharePoint, etc.

Education and Experience:

• Requires BS/BA in Life Sciences with 10+ years of relevant progressive experience in QA/QRM/Manufacturing/Validation within the Pharma / Biopharma industry.

• Previous Quality and/or Risk Management experience required.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
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