Vice President - Quality and Regulatory Affairs

Overview:

Join us as we work towards meeting and exceeding the growing needs of our diverse communities, further our lifesaving strategic goals in a rapidly changing environment, and expand our impact on the local, national, and global communities we serve.

Responsibilities:

The VP establishes a regulatory strategy for CCS-initiated product development projects, advises NYBCe leadership on regulatory issues, prepares regulatory submissions, and represents NYBCe to regulatory and accrediting agencies. The VP applies strong leadership skills to motivate, coach, develop, and retain high-performing Quality staff, and fosters a quality-oriented culture throughout the organization.

• Lead quality management initiatives by crafting, articulating, and implementing a vision that embraces high quality standards for products and services.
• Oversee quality monitoring and improvement programs, while ensuring the organization's compliance with internal and external.
• Lead improvement projects dealing with broad or complex issues, or with strategic impact.
• Make strategic contributions to the design and implementation of product development and clinical research plans. Partner with Research, Clinical, and Operations management to achieve objectives.
• Advise on equipment, process, and method validation strategies.
• Manage relationships with supplier and customer counterparts from a quality and regulatory point of view to support Operations. Ensure quality expectations are defined and agreed upon.
• Serve as an Authorized Official to accrediting and regulatory Serve as key point of contact for managing and directing regulatory and accreditation inspections.
• Manage the preparation of formal meeting packets and cell therapy regulatory submissions to the FDA. Prepare and submit regulatory registrations, applications, and amendments to support operations as assigned.
• Advise CCS clients as requested regarding regulatory submission pathways and content. Participate in preparation of CMC submissions.
• Identify, engage, and collaborate with regulatory experts and consultants as needed.
• Collaborate with executives and senior management in defining organizational goals and action plans.
• Prepare reports to the Board of Trustees as requested to inform them on regulatory risk, compliance, and the state of the organization’s quality management system. Appropriately raise any significant compliance risks or concerns requiring the Board’s attention.
• Drive a collaborative work environment that focuses on creating and maintaining a strong quality and continuous improvement culture within the organization.
• Identify and develop staff talent through mentoring, education, and broadened experience opportunities to ensure a high-performance workforce capable of delivering high quality services responsive to the needs to the organization.

Qualifications:

Education:

• Bachelor’s Degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management
• Master’s degree or higher preferred.

Experience:

• Minimum fifteen years of combined experience in quality management and regulatory affairs related to cGMP manufacturing, clinical trials, and cellular therapies.
• Minimum five years of experience in a leadership role overseeing quality and/or regulatory affairs in a biologics manufacturing or clinical biotherapies environment.
• Providing quality management oversight in a cell therapy manufacturing environment strongly preferred.
• Preparing and managing IND and/or BLA submissions to FDA preferred.
• Experience with European Medicines Agency regulations and guidelines as it relates to cellular therapy is a plus.
• Experience with New York State Department of Health regulations is a plus.

Travel: Up to 20% domestically.

Knowledge:

• Current, expert knowledge of US laws, regulations, and guidelines related to cellular therapies and other FDA regulated biologics, as well as familiarity with the global regulatory environment.
• Knowledge of FDA regulatory submissions preparation and processes.
• Knowledge of clean room manufacturing facility practices and environmental monitoring.
• Broad knowledge of quality assurance methods, principles, and practices, including basic statistical analysis and sampling techniques, auditing, process control, validation, and process improvement methodologies
• Working knowledge of organizational management principles and practices.
• Strong working knowledge of current business productivity software applications.
• Applied knowledge of validation principles and best practices in an FDA regulated environment.

Skills:

• Strategic thinking
• High level of interpersonal skills to handle a variety of complex issues and situations. Position requires demonstrated poise, tact, and diplomacy in dealing with a variety of staff up to and including executive leadership.
• Expert skills to interpret Federal, State, Local and international regulations, standards, technical specifications, and professional guidelines as they apply to NYBCe products and services.

Abilities:

• Authentically builds trusted relationships and collaborates locally and nationally with diverse and multi-functional teams to successfully drive business objectives.
• Ability to lead in a matrix structure to achieve business goals; demonstrated financial acumen and experience developing and managing a budget.
• Ability to communicate clearly and with authority, both in writing and verbally, to others in one-on-one or small group settings. Ability to present information effectively in large group settings.
• Collaborate with others, build consensus, and work effectively in a team environment
• Expert ability to analyze and interpret observational, operational and quality data to monitor process performance and to determine if products and services are performing within defined specifications.
• Ability to conduct studies and investigations, problem analysis, and risk assessments to develop logical and well-documented recommendations.

For applicants who will perform this position in New York City or Westchester County, the proposed annual salary is $270,000.00p/yr. to $280,000,00p/yr. For applicants who will perform this position outside of New York City or Westchester County, salary will reflect local market rates and be commensurate with the applicant’s skills, job-related knowledge, and experience.

Unless otherwise specified, all posted opportunities are located in the New York or Greater Tri-State office locations.