PRINCIPAL DUTIES:

• Strategic Quality Leadership:

• Develop and implement a robust Supplier Quality Management System that ensures all outsourced GMP operations are in compliance with all relevant regulations and industry standards.
• Provide strategic direction and oversight of Quality Assurance activities across all stages of product development and commercialization.
• Lead cross-functional initiatives to promote a culture of continuous improvement, quality excellence, and regulatory compliance.
• Serve as a key member of the Quality Leadership Team, contributing to the development of company-wide strategies and objectives.

• Quality Operations and Batch Disposition:

• Provides GMP Quality Assurance oversight of products manufactured at Contract Development Manufacturing Organizations (CDMOs).
• Provides leadership for significant deviation events or failure investigations at CDMOs and contract test labs. Leads implementation of corrective actions and quality system improvements.
• Leads QA evaluations of product quality at Material Review Board and Quality Management Review.

• Supplier Quality Systems and Compliance:

• Oversee the development and approval of quality documentation, including specifications, SOPs, and policies.
• Lead the Supplier Quality Management program for GMP operations, ensuring timely and appropriate vendor qualification, audits, and ongoing oversight.
• Manage the audit lifecycle, from planning and execution to report review, response evaluation, and closure.
• Ensure effective quality agreements with GMP vendors and oversee GMP quality operations at all facilities.

• Regulatory and Risk Management:

• Support process performance qualification (PPQ) activities, including the review of validation protocols/reports and risk assessments.
• Provide expert guidance on risk management strategies, vendor selection, monitoring, and remediation.
• Oversee the investigation and resolution of deviations, CAPAs, and complaints, ensuring timely closure and compliance with regulatory standards.
• Support and review relevant sections of regulatory submissions, including IND, IMPD, BLA, and NDA documents.

• Continuous Improvement and Innovation:

• Drive the continuous improvement of quality processes, systems, and operations, seeking opportunities for innovation and efficiency.
• Promote a quality mindset throughout the organization, ensuring that all activities align with the highest standards of quality and compliance.
• Lead initiatives to enhance the effectiveness of the QMS, including change control, deviation management, and CAPA systems.

 

REQUIRED QUALIFICATIONS/EXPERIENCE (BASIC QUALIFICATIONS):

• Education & Experience:

• A minimum of 10 years GMP QA management experience in the Biotech/Pharmaceutical industry.
• Experience preparing for and hosting regulatory inspections. Previous experience in responding to regulatory inspections preferred.
• A BS degree in a scientific discipline is required; a post-graduate degree is highly desirable.
• Extensive knowledge of GMP guidelines, regulatory requirements, and industry best practices. Demonstrated knowledge of international regulatory requirements for biotech products and experience in disposition of biotech products to multiple jurisdictions.
• Utilizes strong organizational, interpersonal and communication skills to plan and accomplish goals
• Proven experience in leading quality assurance teams and managing complex quality systems.

• Leadership & Skills:

• Demonstrated ability to lead and influence cross-functional teams at a strategic level.
• Strong management skills, with a focus on process improvement and operational excellence.
• Exceptional verbal, written, and interpersonal communication skills.
• A creative and pragmatic approach to problem-solving, with the ability to drive solutions in a dynamic environment.

Posted On: Tuesday, January 7, 2025