Executive Director, QA Microbiology

Regeneron Pharmaceuticals•Rensselaer, NY

15d•$239,600 - $399,400•Onsite

About The Position

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.

Requirements

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.
Bachelor’s degree in Engineering, Chemistry, Biology or related science/technical field.
Sr Director – 15+ years of experience in a regulated industry (ie., Biotech, Pharma, Medical Device).
Executive Director – 18+ years of experience in a regulated industry (ie., Biotech, Pharma, Medical Device).
Equivalent combination of education and experience will be considered.

Responsibilities

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.