Chief GMP Data Integrity Officer
- Regeneron Pharmaceuticals, Inc.
- Rensselaer, New York
- Start date
- Mar 24, 2023
- Information Technology, Business/Data Analytics, Database Administration
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Pharm Country, Best Places to Work
We are currently looking to fill a Sr Director/Executive Director, Chief GMP Data Integrity Officer position. This position is responsible for the Regeneron Industrial Operations and Product Supply (IOPS) Data Governance and Integrity program. Directs and leads the activities of team. Works closely with business leaders and department subject matter experts to implement data integrity standards into business operations. Serves as the global leader on good practices for their area. Develops and delivers effective training and education programs; works with the business to embed practical steps into procedures, processes and other documentation.
In this role, a typical day might include the following:
Global owner and lead for Data Governance and Integrity – defines the standard and ensures broad understanding across the business
Partners with personnel to define or revise associated business processes to meet defined standards; applies practical education and fosters a culture of documenting processes
Works with department management to build a robust inspection readiness program, champion an inspection ready approach and ensure documentation generation and maintenance all supporting successful inspections
Participates in Regulatory Agency interactions and preparation as related to site inspections and ensures regulatory observations are adequately addressed and completed on schedule
Keeps current on the changing industry landscape and incorporates those findings to continuously improve Regeneron practices and procedures; knowledgeable of process and forensic-based auditing techniques for data integrity
Establishes departmental goals aligned with organization goals
Builds global relationships to gain direct knowledge of operations and influence improvements
Provides mentorship to employees for performance and development
Interviews, hires, orients, and trains incoming personnel
Ensure direct-report staff is appropriately resourced, supported and has the tools and direction to properly complete their function
Establishes programs, procedures, and work instructions to lead the data governance program including metrics, reports, inspection readiness, and both conceptual and practical education
Provides leadership and collaboration within and across the organization at all levels, across functional groups for all data governance integrity matters
Partners with global counterparts to ensure global alignment of processes, systems and procedures, unified communication to user areas, and identification of enhancements
Integrates across IOPS business areas with an eye to gain practical understanding of day-to-day operations
Coach, mentor, and guide staff on changing standards
Identifies risks to operations and collaboratively works with team and business to identify and implement mitigations
Rigorously adheres to organizational basics – models to others the importance of getting the basics right, and reinforcing that standard
Develops personnel, supports a positive, diverse, equal, and inclusive work environment, and builds a strong team.
Technology & Systems
Is responsible for the technology and systems that support the QA team
Health & metrics
Reports status of process performance and ensures timely and accurate metrics for presentation; includes day-to-day operations, program health, status, and action, as well as management review (Right to Operate)
This role may be for you if you:
Have outstanding experience demonstrating ability to partner, influence and incorporate new standards, or extensive experience in changing / revising large-scale program initiatives in the pharmaceutical or biotechnology industry
Have knowledge of one or more of the following pharmaceutical or biotech areas: Manufacturing, Quality Control, Quality Assurance, or Information Technology
Are knowledgeable in applicable federal, state, and local regulations, rules, policies, and procedures such as FDA Guidance on Data Integrity, MHRA Data Integrity Guide, and WHO Guide to Data Integrity
Are able to capture relevant facts, assess, and decide to implement; understands impact to areas and seeks input
Have ability to influence and lead with and without direct line authority
Are skilled in analyzing information of considerable difficulty and drawing valid conclusions
Demonstrate leadership skills and strong interpersonal skills; ability to coach, mentor and build up team members
Can translate ambiguity into action plans for teams
To be considered for this role you must hold a Bachelor’s degree in and the following amount of relevant experience for each level:
Sr Director: 15+ years
Executive Director: 20+ years
Recent leadership experience in a data integrity or data governance role is required. Previous people management and/or team leadership experience required. May substitute proven experience for education requirement.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)$191,300.00 - $376,300.00
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
- Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
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