About the job

Director, Quality Assurance (GXP)

United States, 35% Travel

Full-time, Permanent

Summary:

I am currently working with a Biopharmaceutical company, who are looking for a Director of Quality Assurance (GXP). You will play a pivotal role in leading the organization’s quality program and ensuring compliance with relevant regulations and company policies. Your responsibilities will encompass Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) standards, as well as state, federal, and international regulations.

An integral part of your role will involve integrating the quality system of another company into the organization. This will require your expertise in developing and maintaining their Quality Systems, particularly in the realm of manufacturing.

Primary Responsibilities:

• Ensuring Compliance: You will guarantee that all internal and external activities adhere to applicable laws, regulations, and company policies.
• GMP Adherence: Verifying that the organisations drug substances and drug products are manufactured in strict compliance with GMP guidelines, ensuring the utmost quality and safety.
• Analytical Methods: Overseeing the quality of analytical methods employed, ensuring they meet the required standards for their intended use and stage of development, and aligning with internal quality benchmarks as well as regulatory requirements.
• Documentation Management: Taking charge of the writing and reviewing process of vital governance documents, including SOPs, work instructions, forms, templates, and more. You will ensure that these documents are accurate, up-to-date, and support process improvement and compliance.
• SOP Development: Recommending, creating, implementing, and updating SOPs as necessary to enhance processes, address gaps, and maintain compliance with regulations and industry best practices.
• Quality Standards and Metrics: Implementing, tracking, and managing quality standards, systems, and metrics to maintain regulatory compliance for on-site GMP operations. This involves establishing key performance indicators and regularly assessing our performance against them.
• Quality Management System (QMS): Supporting the improvement and maintenance of our QMS, ensuring its effective functioning across all relevant department areas while maintaining compliance with regulatory agencies.
• Audits and Regulatory Inspections: Coordinating and conducting audits, including leading potential regulatory audits such as those conducted by the FDA. You will report and address findings promptly and efficiently.
• Compliance Guidance: Serving as a compliance resource, you will provide guidance and assistance in resolving moderate to complex deviations, quality investigations, lab investigations, Corrective and Preventive Actions (CAPAs), and change control processes.
• Risk Assessment: Utilizing risk assessment methodologies in quality systems processes to identify and mitigate potential risks to product quality and patient safety.
• Oversight and Monitoring: Providing oversight and monitoring of GMP activities, both internally and externally, as appropriate. This includes partnering with contract manufacturing organizations (CMOs), contract development and manufacturing organizations (CDMOs), and contract testing laboratories (CTLs).

To excel in this position, you will need a Bachelor’s degree in life sciences or a related field, with a Master’s degree preferred. You must possess a minimum of ten years of progressive experience in the regulatory compliance environment, including at least seven years of quality auditing experience in the biotechnology or pharmaceutical industries.