VP of Quality and Regulatory Affairs

Job Code:

Q1050

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JOB DESCRIPTION

The Vice President of Quality and Regulatory Affairs reports to the CEO and President of the Company and is part of the Executive Leadership team. This role is strategically important for the success of Matica Bio’s commercialization goals, providing oversight of Matica Bio’s cell and gene therapy manufacturing operations, and ensuring continuous improvement in the execution of client projects so that our clients’ novel products meet global Good Manufacturing Practices (GMP) regulatory standards for clinical studies and commercial markets.

This position will be expected to lead the global Quality Assurance, Quality Control and Regulatory Affairs functions. The successful candidate will be responsible for coordinating the development and implementation of Quality policies and standards, facilitate client-led and agency-led quality inspections, and provide oversight of both internal and third-party GMP activities supporting the manufacture and approval of client products. This position also participates in strategic leadership supporting the achievement of corporate goals.

RESPONSIBILITIES

  • Responsible for development, implementation, maintenance, and overall success of the company’s quality and regulatory paper-based and electronic programs and strategies, including articulating quality standards and objectives, developing methods to embed quality into the product development and manufacturing processes, establishing vendor relationships and quality standards, and developing and implementing innovative programs to focus employees on improving product quality

  • Leads Quality across development, operations, and supply chain, driving adherence to applicable standards, GMP regulations and company policies and procedures – especially as pertains to the biological production of cell and gene therapies, vaccines, oncolytic vectors and other products utilizing cell-based technologies.

  • Sets quality and compliance goals for the organization; establishes metrics to continuously monitor quality performance; ensures these goals are effectively met.

  • Ensures effective, compliant, and efficient Quality processes and systems across functional areas including internal manufacturing operations, and the entire supply chain network.

  • Responsible for the oversight of internal and external audit programs, including client audit and regulatory agency inspection readiness required for production viral, cell-based and tissue-based products.

  • Monitors and reports deviations per GMP guidance. Develops systems to ensure CAPA investigations are performed and closed in a timely fashion.

  • Oversees systems for audit management. Assures that systems are in place for audit planning and scheduling. Final approver of all audit reports and oversees remediation plans as required.

  • Oversees reporting and closure of compliance issues. Collaborates with the Matica Bio Leadership team and key stakeholders.

  • Expected to keep up to date with current global quality and regulatory guidance’s that cover the GMP manufacture of biologics including cell and gene therapies, human cells, tissue-based products and other similar products.

  • Direct training and oversight of HIPAA practices.

  • Ensures critical and strategic Quality priorities are allocated appropriate resources and sufficient oversight for timely completion.

  • Develops and manages the Quality workforce staffing to meet the growth trajectory of the overall business.

  • Build, develop and lead an engaged workforce to drive a high-performance culture that is innovative, agile, open to change, and constantly learning in a rapid growth and evolving culture.

  • Responsible for developing and managing Matica Bio’s Quality Agreement to be executed between the company and its clients.

  • Conducts, analyzes, and reports out on quality and regulatory trends. Provides Executive management with analysis and remediation plan.

  • Reviews and analyzes GMP quality metrics and coordinates the necessary quality adjustments.

  • Provides guidance, interpretation, support, training, and input on the interpretation and implementation of regulations, guidelines, company procedures, and policies across the entire organization.

  • Advises executive management on external environment and strategic compliance trends impacting our business.

  • Creates and maintains an environment where employees are fully engaged, willing to speak up and can develop and thrive.

QUALIFICATIONS

​EDUCATION

  • BS in Chemistry, Microbiology, Life Sciences, or related field

  • MS or related graduate level degree preferred

KNOWLEDGE/SKILLS/EXPERIENCE

  • 15+ years of progressive Quality and Regulatory Affairs experience in an FDA regulated biopharmaceutical company is required. The majority of experience should be in support of development and operations functions.

  • Experience working in the CDMO industry preferred.

  • Track record of success in building or rebuilding elite Quality organizations from the ground up.

  • Functional working knowledge of requirements for ISO 13485, 21 CFR 210/211, 600-610, 820 and other applicable regulations or FDA guidance for industry.

  • Broad understanding of current QA/RA practices as they apply to product development, manufacturing and commercial operations in an FDA GMP regulated and ISO 13485 certified environment.

  • Prior experience filing Investigational New Drugs (IND’s), Biologics License Applications (BLS’s) and Drug Master Files (DMF’s).

  • BSL filing experience. 

  • Excellent interpersonal and collaboration skills; communicates well orally and in writing. Can influence both internal and external stakeholders.

  • Demonstrated experience working with clients and regulatory agencies

  • Demonstrated expertise in effectively managing customer and regulatory agency audits.

  • Experience in the development of the Quality organization and structure to meet company goals and objectives.

  • Financial management experience, awareness, and strong acumen to make sound business decisions, good judgments and quick decisions