Sr QA Validation Specialist (CSV)

Working under the Quality Assurance organization this position is responsible for ensuring IT systems, programs and quality events are robust and meet regulatory agency expectations. The position will liaise with the IT and broader QA organizations to ensure all aspects of IT related programs are in compliance with regulatory agency expectations and internal company policies and procedures.

As a Sr QA Validation Specialist (CSV), a typical day might include, but is not limited to, the following: 

• Managing compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions

• Investigating and troubleshooting problems which occur and determine solutions or recommendations for changes and/or improvements

• Reviewing, editing and approving deviation notifications, investigations, and corrective actions

• Reviewing, editing and approving change control and SOPs

• Participating and supporting the Quality Risk Management (QRM) principles in the formal and informal risk assessment initiatives

• Supporting the development, review and approval of Quality Assurance Agreements (QAA), along with the Approved Supplier List (ASL) process

• Presenting and/or defending at both internal and external (regulatory) audits and presenting in a “pressure test” scenario the technical area that they are SME

• Supporting quality objectives by contributing information on best practices in industry and providing recommendations on strategic plans and reviews

• Staying up to date with current industry trends and regulatory requirement updates and drive changes and improvements based on trends

• Presenting project and program status and metrics to Senior Management

• Acting as Technical Subject Matter Expert (SME)

• Leading special projects as assigned

• Providing training and mentorship to less experienced personnel

• Leading direct reports if required

• Some travel may be required (approximately 25%)

This role might be for you if:

• You have detailed knowledge of 21CFR11 and Annex 11 as well MHRA, FDA and WHO data integrity guidelines

• You have strong knowledge and experience with Computer Systems Validation and/or IT Auditing

• You have an understanding of the interdependencies of change management, deviation and continuous improvement.

• You have the ability to define a vision and implement interim milestones

• You have the ability to work in a dynamic organization where innovative solutions are required to ensure a high-level of quality is achieved within required timelines

• You have knowledge of global organizations, process mapping and process improvement

• You have strong knowledge of applicable federal, state and local regulations, rules, policies and procedures

• You have the ability to capture relevant facts, assess, and decide to execute

• You are skilled in analyzing information of considerable difficulty and drawing valid conclusions

• You are comfortable navigating ambiguity with the ability to help define actions

To be considered for this position you must hold a BA/BS degree. For Senior Specialist: a minimum of 5 years directly related experience within Pharma or Biotech or equivalent combination of education and experience. Recent experience in a data integrity role is preferred. 

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Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Comp