Job Summary

The VP, Global Quality, Regulatory is responsible for leading and driving regulatory compliance and quality assurance initiatives across the organization, while ensuring global site alignment to corporate quality. This role will operate as a liaison and partner across the organization to ensure global strategic alignment and compliance within the CMO business units. 

This role involves ensuring compliance with FDA 21 CFR 210, 211, 820 and other regulations as applicable, ISO standards, and EU GMP guidelines and relevant annexes based on site specific requirements. Furthermore, this leadership role will support reporting directors and managers in robust, comprehensive quality system reporting and metrics, regulatory audits, and the effective establishment and maintenance of quality management systems across the business units.

Essential Job Duties and Responsibilities

• Develop, define, and continuously improve corporate quality policy to ensure compliance with FDA 21 CFR 210, 211, and 820, ISO standards, and EU GMP guidelines and annexes based on site specific requirements.
• Be directly responsible for corporate quality policy that informs and drives site quality management systems for ensuring product quality and compliant operations. 
• Ensure products are manufactured, stored, and distributed in compliance with all applicable regulatory standards to guarantee the quality and safety of products.
• Support auditing processes for medical devices, sterile injectables, and other GxP platforms. Lead communication and support interactions with FDA, MHRA and other regulatory authorities, maintaining positive and proactive relationships. 
• Provide strategic leadership and direction to quality assurance, quality control, and regulatory teams, ensuring alignment with business objectives and partnership with operations.
• Drive continuous improvement initiatives and uphold a culture of quality within the organization.
• Support the development of training programs and initiatives to enhance employee understanding and execution of regulatory requirements and quality standards.
• Monitor the regulatory environment and raise changes in regulatory requirements or views that may affect the organization and organize change implementation.
• Collaborate with R&D, manufacturing, and other departments to integrate quality and compliance considerations in product development and manufacturing processes.
• Support reviews and audits of SMC CMO facilities and processes to ensure compliance and quality consistency.

Education and Essential Qualifications

• Bachelor’s degree in a related scientific or engineering field is required. Applicable certifications, MBA or advanced degree in a related field is preferred.
• Minimum of 10 years of collective experience in quality assurance and/or regulatory affairs within the medical device and sterile injectable manufacturing industries.
• In-depth knowledge of GMP regulations, specifically:
  • 21 CFR 210 (Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General)
  • 21 CFR 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals)
  • 21 CFR 820 (Quality System Regulation for Medical Devices)
  • EU GMP and relevant annexes 
  • ISO 9001, 13485 and other applicable ISO standards

Desirable Qualifications

• Previous experience working with any of the following preferred: contract manufacturing organizations (CDMO/CMOs), international teams, start-ups and routine business, devices, combination products, sterile injectables, injection molding 
• Experience with electronic quality management systems and ERP within highly regulated industry (iQMS, Sage, Dot Compliance preferred)
• Demonstrated leadership skills with the ability to lead and develop a high-performing, global, quality team
• Excellent communication skills, capable of effectively presenting information to executive leadership 
• Strategic thinker with analytical problem-solving capabilities and meticulous attention to detail
• Able to thrive in a fast-paced, changing environment and manage multiple priorities

ADA Requirements

• Typically sits, grasps items and performs keyboarding for frequent operation of a computer
• Stand, walk, bend, reach or otherwise move about occasionally
• Lift, move or otherwise transfer items up to 30 lbs. occasionally
• Occasional exposure to typical machine and manufacturing facility physical hazards
• Travel by air or car as needed, approximately 20%

At SMC Ltd. we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process. 

SMC Ltd. is an equal opportunity employer. M/F/D/V; this organization uses E-Verify.

Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.

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