Senior Director, Quality AssuranceNew

Kaleo - Richmond, VA

Full-time - Senior

Remote - Richmond, VA

Professional, Scientific, and Technical Services

About the position

The Senior Director, Quality Assurance at Kaléo will play a pivotal role in the development and production of innovative medical countermeasures, ensuring that all quality systems are robust and compliant with regulatory standards. This position is crucial as Kaléo expands its Quality leadership team to support its growth and commitment to delivering meaningful healthcare solutions. The Senior Director will serve as the internal Quality Assurance subject matter expert (SME), responsible for establishing and maintaining quality systems that govern the development and production of pharmaceutical, device, and combination products. This includes overseeing document review, product release, investigations, corrective actions, exceptions, change control, training, document management, supplier quality, product complaints, and regulatory compliance. The individual will ensure that the quality systems align with Kaléo policies, FDA regulations, and European Union guidance documents, maintaining an inspection-ready status at all times. In this leadership role, the Senior Director will manage a highly motivated Quality Assurance team, focusing on patient safety and product quality. The responsibilities include overseeing quality assurance programs and processes, ensuring regulatory compliance throughout the product lifecycle, and leading investigations into out-of-specification (OOS) results and deviations. The Senior Director will also implement a GXP training program for employees, establish a trending program for quality metrics, and create and revise Quality System documents such as the Quality Manual and Standard Operating Procedures (SOPs). Additionally, the role involves performing audits of third-party organizations for compliance with various regulatory standards and providing technical oversight during validation runs. This position offers an opportunity to lead a talented team, work with life-saving products, and make a significant impact on the company's success. The ideal candidate will possess strong leadership skills, the ability to manage multiple priorities, and a commitment to fostering an inclusive workplace.

Responsibilities

• Oversee quality assurance programs, processes, and facilities ensuring regulatory compliance in the manufacture and development of products from beginning to end.
• Oversee all activities of the QC unit as defined in applicable regulatory and compliance related standards and guidance documents.
• Ensure comprehensive technical and administrative review of the batch and analytical data generated by manufacturing and GMP test laboratories relating to raw material, in-process, and product release.
• Oversee final batch disposition of manufactured products.
• Administer Quality Systems: document control function, change control, CAPA, deviations, NCMR, product complaints, etc.
• Lead investigations and corrective action identification and implementation process for OOS and deviations.
• Ensure on-time closure of corrective action/preventive action items.
• Implement GXP training program for company employees.
• Establish trending program for quality metrics.
• Create, review, and revise Quality System documents, such as Quality Manual, SOPs, and Quality Agreements.
• Compile training files for Kaléo employees and consultants.
• Perform audits of Third-Party Organizations for GMP, GLP, GCP, and/or 21 CFR Parts 4, 210/211, 820 QSR, ISO 13485, ISO 14971 compliance.
• Provide technical and/or quality oversight during process, method and equipment validation runs.
• Consult on computer system validation for data systems.
• Ensure design control files are accurate and complete.
• Establish and manage external Quality Assurance functions as needed.
• Facilitate quality systems and quality issue review related meetings.
• Oversee the Quality Management Review process and facilitate meetings.
• Act as the Management Representative for Kaléo.

Requirements

• BS Degree in a Life Science.
• Minimum of 15 years quality related experience in biopharmaceutical, parenteral manufacturing, or medical devices preferred, with a minimum of 10 years supervisory/leadership experience.
• Process Excellence/Six Sigma/Lean Certification.
• ASQ Certifications (CQA/CQE).

Nice-to-haves

• Advanced degree preferred.
• Experience related to Combination Products (drug + device) strongly preferred.
• Experience fulfilling government contracts strongly preferred.