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Manager QA (Change Control)

Employer
Regeneron Pharmaceuticals, Inc.
Location
Troy, New York
Start date
Mar 29, 2024

View more

Discipline
Quality, Quality Assurance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

We are currently looking to fill a Manager, Quality Assurance position on the Quality Assurance Change Control Team. This role works within the QA Change Control Team to facilitate cross-departmental best practices in change evaluation, ensure smooth facilitation of change control activities, and support the global team.

As a Manager, Quality Assurance, a typical day might include the following:

  • Developing and facilitating best practices for QA departmental change evaluations

  • Sponsoring and advocating for Continuous Improvement activities and working with other members of the Quality Assurance team and/or end users of the system on the development and implementation of updates to relevant processes

  • Developing relationships with end users and providing advice on best practices/ strategy for departmental change evaluation

  • Developing, monitoring, and communicating metrics to ensure the health of the Change Control System

  • Ensuring support infrastructure fills the needs of QA and end users across IOPS sites.

  • Partners with counterparts to ensure global alignment of processes, systems, and procedures

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

  • Assisting as needed in audits and inspections

  • Responsible for leading, mentoring and developing direct reports.

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

  • Demonstrated ability to perform independent work requiring attention to detail, accuracy and scientific judgment and a consistent record of shifting thought processes quickly from one task to another

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

  • Proven track record of 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

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

To be considered for this role you must hold a BA/BS degree in life sciences discipline or related field (chemistry, biology, or pharmacy preferred) and the following minimum amounts of relevant experience for each level:

  • Manager 7+ years

  • Senior Manager 8+ years

Experience preferred in pharmaceutical or biologics manufacturing environment, including some supervisory and/or leadership experience. May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

#REGNQA

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$104,300.00 - $199,000.00

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
US

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