Principal QA Specialist (Change Control)

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Job description

We are currently looking to fill a Principal Quality Compliance Specialist to join the Quality Assurance Change Control Business Process Team. The Quality Compliance Specialist ensures adherence to cGMPs, internal, external, and international requirements with respect to change control activities. This role is integral to facilitating process improvements, ensuring robust training for system end users, and supporting the Quality Management System.

As a Principal Quality Compliance Specialist, a typical day might include the following:

• Developing and executing a comprehensive training strategy for the change control quality system.

• Leading training for end users of the Change Control System.

• Partnering with counterparts to Identify, Develop, and Implement Continuous Improvements to the Change Control System, Process and associated procedures.

• Sponsoring and advocating for Continuous Improvement activities.

• Developing, monitoring, and communicating metrics on training effectiveness.

• Ensuring global alignment of processes, systems, and procedures in collaboration with counterparts.

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

• Assisting in audits and inspections.

This role might be for you if:

• Knowledgeable in Biotech/ Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulatory.

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

• Skilled in comprehending, analyzing, and interpreting process and systems information, technical procedures, reports, and regulations to make decisions in a GMP environment.

• Demonstrated strong organizational abilities, with a record of creating structure from diverse sources.

• Proven in establishing and maintaining effective working relationships with managers and employees as well as influencing individuals of various levels to gain understanding and/or acceptance of an idea, policy, procedure, or plan.

• Possessing 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 digital literacy in Microsoft (MS) Word, Excel, PowerPoint, and SharePoint required. Experience with Quality Management Systems heavily preferred.

• Experience in change control function strongly preferred.

To be considered for the Quality Compliance Specialist position you must have a Bachelors in a scientific or engineering discipline or related field with the following minimum amounts of relevant experience for each level, in a combination of quality, production, engineering, regulatory (chemistry, manufacturing and control) and/or laboratory, with demonstrated accomplishments in effectively implementing cGMP requirements.

• Senior Specialist 5+ years

• Principal Specialist 8+ years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

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 Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$76,100.00 - $145,500.00

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