Job Description

Senior Director, Quality (Pharmaceutical/Biotech)

Join to apply for the Senior Director, Quality (Pharmaceutical/Biotech) role at Cristcot

Senior Director, Quality (Pharmaceutical/Biotech)

Join to apply for the Senior Director, Quality (Pharmaceutical/Biotech) role at Cristcot

We are in the business of addressing the problem within the problem. We focus on the details and connections that other, major pharma companies have left ignored for years. There are better ways, better drugs and better formulations and we will make them a reality by analyzing, understanding and solving the problems within the problems.

About the Role

The Sr. Director of Quality will be responsible for leading the development, implementation, and maintenance of a robust Quality Management System (QMS) that ensures compliance with Good Manufacturing Practices (GMP) and other regulatory requirements. This leadership position involves collaborating with both internal and external stakeholders to ensure product quality and regulatory compliance throughout the entire product lifecycle, from development to commercialization.

Responsibilities

• Lead the deployment, implementation and continuous improvement of Quality Processes and the Quality Management system.
• Ensure compliance with cGMP, FDA, and ISO/ICH standards.
• Report directly to the CEO and serve as the primary authority on quality decisions, risk assessments, and regulatory compliance.
• Quality Management:
• Lead the development and execution of a strategic vision for the Quality Management System (QMS), aligning it with the companys long-term business objectives.
• Oversee the implementation and maintenance of quality systems that ensure compliance with global regulatory standards, including FDA, EMA, ICH, etc.
• Ensure effective management of CAPA (Corrective and Preventive Actions), change controls, deviations, and other GMP-related processes.
• Lead continuous improvement initiatives within the QMS, focusing on efficiency, effectiveness, and compliance with all applicable GMP regulations.
• Oversee the revision of SOPs, policies, and Quality Agreements to stay aligned with regulatory updates and business needs.
• Ensure training programs related to GMP, GCP, and other quality standards are effectively developed and executed.
• Documentation and Record Control:
• Manage GxP document control and records management systems, ensuring proper approval, archiving, and retrieval processes.
• Serve as the business process owner for the companys electronic quality management system (eQMS), ensuring system validation and continuous improvement.
• Implement and oversee the Computer System Quality Assurance and Data Integrity programs for electronic-based systems in compliance with 21 CFR Part 11.
• Regulatory Compliance and Inspection Readiness:
• Ensure the organizations quality systems remain inspection-ready and in compliance with regulatory requirements for GMP audits or inspections.
• Collaborate with regulatory affairs and cross-functional teams to support regulatory submissions, including providing necessary documentation and ensuring compliance.
• Support site preparation for regulatory inspections, including training and personnel preparation.
• Manage the storage and organization of Quality Agreements, ensuring proper record keeping.
• Operational Leadership and Continuous Improvement:
• Lead continuous improvement initiatives across quality operations, focusing on operational efficiency, risk reduction, and product quality enhancement.
• Provide strategic leadership and direction to quality operations teams, ensuring alignment with business goals and regulatory demands.
• Develop metrics to monitor and report on the performance of quality operations, ensuring that corrective actions are taken when necessary.
• Promote a strong Quality culture within the organization, identifying compliance risks and collaborating on solutions.

Qualifications

• Bachelors degree in life sciences, chemistry, engineering, or related field; advanced degree (MS, PhD, MBA) preferred.
• Minimum of 15 years of experience in quality assurance, quality systems, and/or quality operations within the pharmaceutical, biotechnology, or life sciences industries.
• At least 5 years of leadership experience in quality systems management.
• Proven experience managing GMP operations, QMS, and vendor management, including oversight of CMOs.
• Deep knowledge of global regulatory guidelines (FDA, EMA, ICH) and their application to Quality Operations.
• Experience supporting both clinical and commercial stage programs, with a strong understanding of the product lifecycle.
• Strong leadership, project management, and organizational skills with the ability to multitask and prioritize in a fast-paced environment.
• Excellent verbal and written communication skills, with the ability to collaborate effectively across functions and at all organizational levels.
• Demonstrated ability to lead cross-functional teams and manage external vendors and stakeholders.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Paid maternity leave

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