GSK
Overview
GSK is currently looking for a Quality System & Data Associate Director to join our team in Rockville, MD. The Quality System & Data Associate Director provides leadership to a team of Quality professionals and is responsible for data integrity and governance, document control, training compliance, QMS deployment, and driving the site Quality Improvement Plan. The role also drives GPS for Quality, Quality Culture and embeds Digital Strategy into the Quality organization. The Quality System & Data Associate Director reports to the Site Quality Director and is part of the site Quality Leadership Team (QLT). Responsibilities
Provide leadership and strategy for the 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 regulatory and GSK requirements. Manage updates to site quality systems including VQMS and 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. Maintain current knowledge of compliance requirements, FDA regulatory developments and industry trends; provide interpretation of regulatory quality and compliance requirements and ensure integration into site quality systems. Create and drive 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. Participate in the Quality Leadership Team (QLT) to contribute to the overall quality strategy and objectives. Champion initiatives for Quality Culture at the site with the Quality Leadership Team (QLT). Basic Qualifications
BS/BA Degree At least 7 years of experience in quality control or quality assurance within the pharmaceutical or biopharmaceutical industry Minimum of 3 years’ quality assurance (compliance, quality systems and/or product release) Preferred Qualifications
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. Fully versed in GMPs, NIH Guidelines, FDA and other regulatory agency compliance requirements for GMP manufacturing site. 3+ years in leadership experience managing a team Prior experience with leading significant improvement programs Experience with FDA or other health agencies’ inspections Strong interpersonal and leadership skills; able to function in a team-based organization Strong verbal and written communication skills Capable of providing direct supervision in a team-oriented atmosphere Ability to interact with peers, subordinates and senior personnel in a multidisciplinary environment Ability to prioritize and decide appropriate courses of action Proven ability to champion change and innovation Effective at implementing decisions Why GSK?
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact health and focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases. We are committed to creating an environment where our people can thrive and focus on what matters most. Equal Opportunity Employer.
GSK provides equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, national origin, age, disability, genetic information, military service or any other status protected by applicable law.
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GSK is currently looking for a Quality System & Data Associate Director to join our team in Rockville, MD. The Quality System & Data Associate Director provides leadership to a team of Quality professionals and is responsible for data integrity and governance, document control, training compliance, QMS deployment, and driving the site Quality Improvement Plan. The role also drives GPS for Quality, Quality Culture and embeds Digital Strategy into the Quality organization. The Quality System & Data Associate Director reports to the Site Quality Director and is part of the site Quality Leadership Team (QLT). Responsibilities
Provide leadership and strategy for the 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 regulatory and GSK requirements. Manage updates to site quality systems including VQMS and 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. Maintain current knowledge of compliance requirements, FDA regulatory developments and industry trends; provide interpretation of regulatory quality and compliance requirements and ensure integration into site quality systems. Create and drive 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. Participate in the Quality Leadership Team (QLT) to contribute to the overall quality strategy and objectives. Champion initiatives for Quality Culture at the site with the Quality Leadership Team (QLT). Basic Qualifications
BS/BA Degree At least 7 years of experience in quality control or quality assurance within the pharmaceutical or biopharmaceutical industry Minimum of 3 years’ quality assurance (compliance, quality systems and/or product release) Preferred Qualifications
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. Fully versed in GMPs, NIH Guidelines, FDA and other regulatory agency compliance requirements for GMP manufacturing site. 3+ years in leadership experience managing a team Prior experience with leading significant improvement programs Experience with FDA or other health agencies’ inspections Strong interpersonal and leadership skills; able to function in a team-based organization Strong verbal and written communication skills Capable of providing direct supervision in a team-oriented atmosphere Ability to interact with peers, subordinates and senior personnel in a multidisciplinary environment Ability to prioritize and decide appropriate courses of action Proven ability to champion change and innovation Effective at implementing decisions Why GSK?
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact health and focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases. We are committed to creating an environment where our people can thrive and focus on what matters most. Equal Opportunity Employer.
GSK provides equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, national origin, age, disability, genetic information, military service or any other status protected by applicable law.
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