Associate Manager Engineering Compliance
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 . Responsible for overseeing a team of Engineering Compliance Specialists in the Rensselaer Technical Operations Engineering department that manages deviation investigations, implements Corrective and Preventive Actions CAPA , supports regulatory inspections, authors SOP and Life Cycle Documentation, facilitates change controls, as well as other compliance tasks/functions . Essential Duties and Responsibilities include, but are not limited to, the following . Responsible for ensuring training, development, and compliance of direct reports . Sets priorities for Engineering Compliance department . Tracks progress on Engineering quality system deliverables, including deviation investigations, CAPAs, and change controls, ensuring quality and accuracy of documentation and adherence to due dates . Provides tracking and trending of compliance activities ex, change controls, investigations, corrective and preventive actions and other compliance metrics for the Engineering department . Interfaces regularly with Quality Assurance, Automation, Manufacturing, Facilities, and other functional areas in order to facilitate decisions pertaining to quality system deliverables . Performs and supports investigations and root cause analysis for equipment-related and compliance-related events . Owns change controls on behalf of subject matter experts and interprets testing requirements based on technical documents provided by subject matter expert . Develops and updates departmental policies, Standard Operating Procedures, Work Instructions, Job Aids, System Design Specifications, and Equipment Specifications . Evaluates Engineering department systems and processes for adherence to cGMPs and industry best practices, and implement changes/improvements as needed . Acts as a liaison between Engineering and Quality/Regulatory groups to address compliance-related items . Facilitates and/or assists Engineering Department in preparation of regulatory inspections . Acts as a department liaison during regulatory inspections and coordinates post-inspection activities . Education and Experience . Requires BS or higher in engineering and 6+ years of related experience working in a cGMP environment or in a regulated industrial facility. Direct experience with biopharmaceutical process equipment and 2-3 years of experience in a leadership role is preferred . 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.