Executive Director, QA Sterility Assurance

Regeneron; Town of East Greenbush (NY); On-site; USD 239,600 - 399,400; Full time

Benefits offered by this job

Health insurance

401(k) company match

Paid time off

Fitness centers

Job summary

A leading biotech firm is seeking an Executive Director for QA Microbiology. This role requires the implementation of a robust microbiology program and strong oversight of compliance with global regulations. Candidates must have at least 18 years of experience in a regulated industry and possess a Bachelor’s degree in a related scientific field. The role emphasizes risk management, quality assurance, and leadership in a dynamic environment. The position is based in East Greenbush, New York, and offers a competitive salary package.

Qualifications

• 15+ years in a regulated industry (Biotech, Pharma, Medical Device) for Sr Director.
• 18+ years in a regulated industry for Executive Director.

Responsibilities

• Implement a microbiology program based on quality and regulatory requirements.
• Monitor the performance and improve the microbiology program.
• Lead decision-making in microbiology to ensure product safety.

Skills

Microbiology knowledge

Quality risk management

Strong communication skills

Regulatory understanding

Education

Bachelor’s degree in Engineering, Chemistry, Biology or related field

Job description

Regeneron is hiring! The Executive Director, QA Microbiology is responsible for the development and execution of the strategy and plan for the Regeneron GMP Microbiology program. The individual in this position is also responsible for providing direction to the function areas to ensure high-quality, safe, and effective products that are compliant with global regulatory expectations with respect to microbiological topics. This position will direct the efforts of the applicable functional areas in support of compliance and business objectives and will ensure that the Microbiology program remains current with industry expectations and help liaison with subject matter experts within the lines of businesses.

In this role, a typical day might include the following:

• Implement a value-added microbiology program based on sound science and the application of the appropriate quality, regulatory and legal requirements.
• Monitor the performance of the microbiology program using the appropriate metrics and demonstrate a commitment to continuous improvement.
• Embed quality tools and risk management processes within the microbiology program.
• Stay abreast of changing requirements/expectations and proactively address within the microbiology program.
• Use quality and risk management tools to make timely, science-based decisions to protect patient safety.
• Implement appropriate solutions that address complex technical, legal and global regulatory standards.
• Partners with QA Operations functions within the lines of business to translate strategy to implementation, and ensure compliant and robust aseptic practices.
• Demonstrate confidence during difficult decision-making and influence internal and external business partners to ensure acceptable outcomes.
• Lead as microbiology decision maker to ensure the safety and effectiveness of the products.
• Represent as the face of Regeneron to internal and external stakeholders, including regulatory agencies and corporate partners regarding microbiological topics.
• Translate the vision and business strategies of the microbiological program into executable action plans.
• Ensure the Microbiological Control Strategy is transparent and the organization is engaged in its execution.
• Allocate resources based on microbiology program priorities and corresponding business needs.
• Establish high standards for performance management and accountability to achieve microbiological and organizational objectives.

This Role Might Be For You If You Have

• Comprehensive knowledge of microbiological expectations throughout drug development process, pharmaceutical technology, drug manufacturing processes and related issues, drug laws, global regulations, and guidelines, particularly CMC and GMP.
• Experience building up a quality culture and quality management capabilities.
• Comprehensive knowledge and experience in CMC section content for investigational and marketed product submissions (IND, BLA, CBE, PAS) for FDA and equivalent submissions for Europe.
• A sense of passion and commitment for delivering things as quickly and efficiently as possible.
• The ability to think and operate in a rapidly evolving and ambiguous environment.
• Ability to articulate and execute concepts for developing and ensuring the highest quality throughout the network (internal and external).
• Intellect for quality risk identification, mitigation, and management.
• Strong communication skills —written and oral.
• Experience with businesses in different phases of the business lifecycle and the quality and validation issues associated with these phases.

Role

To be considered for this role you must hold a Bachelor’s degree in Engineering, Chemistry, Biology or related science/technical field and the following amount of experience in a regulated industry (ie., Biotech, Pharma, Medical Device) for each level:

• Sr Director – 15+ years
• Executive Director – 18+ years

Level to be determined based on qualifications relevant to the role. Equivalent combination of education and experience will be considered.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.

Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

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)

$239,600.00 - $399,400.00