Quality Compliance Specialist (Change Control)

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: The Quality Compliance Specialist will ensure quality and compliance to cGMPs, internal, external and international requirements with respect to change control activities. The position responsibilities include day-to-day quality assurance review and approval of change proposals, facilitating cross functional meetings and providing guidance and consultation to change proposal owners.

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

• Review, assess, edit, and approve change control documentation to ensure compliance with quality, regulatory and SOP requirements.

• Coach and train others on change control tools and processes and evaluate change control processes and tools to drive continuous improvement. Monitor and communicate metrics and trend reports to management for the Change Control system.

• Interpret compliance and regulatory requirements for incorporation into departmental systems, procedures and documentation.

• Support regulatory and customer audits.

• Lead Change Control Committee meetings and act as point of contact for notification of partner change notices and inter-company change control related communication.

Knowledge, Skills and Abilities:

• Knowledgeable in Biotech/ Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulatory. Experience in change control function strongly preferred.

• Demonstrated ability to perform independent work requiring attention to detail, accuracy and scientific judgment and a proven ability to shift thought processes quickly from one task to another.

• Demonstrated ability to comprehend, analyze and interpret process and systems information, technical procedures, reports and regulations to make decisions in GMP environment.

• Proven ability to establish and maintain effective working relationships with managers and employees and the ability to influence/persuade individuals of various levels within the organization to gain understanding and/or acceptance of an idea, policy, procedure or plan.

• Possess excellent interpersonal, written and oral communication skills with the ability to utilize active listening skills to understand concerns or reasoning in order to be responsive, gain trust and build strategic relationships.

• Proficient computer skills in Microsoft (MS) Word, Excel and PowerPoint required. Experience with electronic quality systems preferred.

Education and Experience:

• Associate Level - Requires BS/BA in scientific or engineering discipline or related field with 0-2 years combination of quality, production, engineering, regulatory (chemistry, manufacturing and control) and/or laboratory experience, with demonstrated accomplishments in effectively implementing cGMP requirements.

• Mid Level - Requires BS/BA in scientific or engineering discipline or related field with 3-5 years combination of quality, production, engineering, regulatory (chemistry, manufacturing and control) and/or laboratory experience, with demonstrated accomplishments in effectively implementing cGMP requirements.

• Sr Level - Requires BS/BA in scientific or engineering discipline or related field with 5+ years combination of quality, production, engineering, regulatory (chemistry, manufacturing and control) and/or laboratory experience, with demonstrated accomplishments in effectively implementing cGMP requirements.

• Relevant experience may be considered in lieu of educational requirement.

*Level will be determined based on skills and related experience.*

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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