Director - Quality Systems and Compliance Jobs in South Waltham, MA | Hourly Jobs
Scientific / QA

Director – Quality Systems and Compliance

full-time

Director, Quality Systems and Compliance- Waltham, MA Job Summary The Director, Quality Systems & Compliance will play a lead role in the further development and management of the Quality Management System in accordance with applicable global regulatory requirements and business objectives. This is a high visibility position that will play a critical role in partnering with our parent company. Responsibilities Oversight for companywide GxP training programs, ensuring a clear line of sight from training requirements to specific GxP job functions aligned to job descriptions Lead the further development, execution, and maintenance of all aspects of the (internal and external) audit and inspection readiness programs Participate in the continuous improvement of the inspection readiness program and implementation of additional initiatives Develop, review, and ongoing monitoring of quality agreements and associated contracts Ownership of the GxP Training, Supplier Management, and GxP documentation systems Assist with the execution of the Quality Management Review process, including oversight of analysis and reporting of Quality System and supplier performance metrics Ownership of the supplier qualification program, inclusive of audit planning, logistics, and audit execution over the general GxP landscape Foster cross-functional collaboration to execute ongoing risk assessments of contracted service providers to ensure accurate classification and handling of suppliers Develop, monitor, and improve quality processes which are scalable and sustainable to meet the growing needs of the organization Foster a quality mindset throughout the company by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions Assist with presenting the management review of quality compliance and operational KPIs to ensure the identification of and timely mitigation of unfavorable trends Qualifications A minimum of 12 years of experience in related Biopharmaceutical Quality or Compliance roles A BA or BS is preferred though long-time experience in QA may be acceptable Strong interpersonal and organizational skills and attention to detail Thorough knowledge of Quality Assurance (GxP), Quality Systems, and Compliance to ensure subject safety, data integrity, product quality, and operational compliance Qualified auditor status preferred Proven experience managing/influencing stakeholders across a broad spectrum of GxP topics Proven experience regarding initiating or ownership of inspection readiness initiatives Strong leadership skills with the ability to thrive in a high throughput environment Ability to lead and manage projects/teams within corporate objectives and project timelines Previous Veeva and ComplianceWire experience required