Quality System and Data Associate Director

Role Summary

Quality System & Data Associate Director located in Rockville, MD. Provides leadership to a team of Quality professionals and oversees data integrity and governance, document control, training compliance, and Quality Management System (QMS) deployment, as well as defining and driving the site Quality Improvement Plan. Drives GPS for Quality, Quality Culture, and embeds Digital Strategy into the Quality organization. Reports to the Site Quality Director and is part of the site Quality Leadership Team (QLT).

Responsibilities

• Provide leadership and strategy for site data integrity & governance program working closely with central and site teams.
• Manage document control processes, ensuring accurate and timely documentation of all quality-related activities.
• Ensure comprehensive training compliance for all relevant personnel, maintaining up-to-date training records and facilitating necessary training programs.
• Lead the implementation and maintenance of the Quality Management System (QMS), ensuring it meets all regulatory and GSK requirements.
• Manages updates to site quality systems including VQMS, MERP through appropriate change management procedures.
• Develop, implement, and monitor the Quality Improvement Plan, driving continuous improvement initiatives.
• Collaborate with cross-functional teams to ensure alignment and integration of quality systems and processes.
• Maintains a thorough and current working knowledge of compliance requirements and policies, FDA regulatory developments and industry trends and ethical pharmaceuticals. Provides interpretation of regulatory quality and compliance requirements and ensures integration into site quality systems.
• Responsible for creating and driving the Rockville Quality digital strategy in collaboration with site and central functions.
• Provide leadership and direction to a team of 5-10 quality professionals, fostering a culture of quality and compliance.
• Actively participate in the Quality Leadership Team (QLT) to contribute to the overall quality strategy and objectives.
• Championing initiatives for Quality Culture at site with the Quality Leadership Team (QLT)

Qualifications

• Required: BS/BA Degree
• Required: At least 7 years of experience in quality control or quality assurance within the pharmaceutical or biopharmaceutical industry
• Required: Minimum of 3 years’ quality assurance (compliance, quality systems and/or product release)
• Preferred: In-depth experience in quality systems, including validation, documentation, compliance, and running a high volume, rapid turnaround operation. Strong technical understanding of industry and science practices related to the business.
• Preferred: Fully versed in GMP’s, NIH Guidelines, FDA and other regulatory agency compliance requirements for GMP manufacturing site.
• Preferred: 3+ years in leadership experience managing team
• Preferred: Prior experience with leading significant improvement programs.
• Preferred: Experienced with FDA or other health agencies’ inspections
• Preferred: Strong interpersonal and leadership skills. Solid team player able to function within team-based organization.
• Preferred: Strong verbal and written communication skills.
• Preferred: Capable of providing direct supervision in a team-oriented atmosphere.
• Preferred: Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, supply chain operations, production, QC, and EHS.
• Preferred: Able to prioritize and decide appropriate course of actions.
• Preferred: Proven ability to champion change and innovation
• Preferred: Effective at implementing decisions