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 critical in overseeing data integrity and governance, document control, training compliance, Quality Management System (QMS) deployment, as well as defining and driving the site Quality Improvement Plan. The role also includes responsibility for driving GPS for Quality, Quality Culture and embedding 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).

KEY 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)

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• BS/BA Degree
• At least 8 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, i.e.)

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• 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 GMP’s, NIH Guidelines, FDA and other regulatory agency compliance requirements for GMP manufacturing site.
• 3+ years in leadership experience managing team
• Prior experience with leading significant improvement programs.
• Experienced with FDA or other health agencies’ inspections
• Strong interpersonal and leadership skills. Solid team player able to function within team-based organization.
• Strong verbal and written communication skills.
• Capable of providing direct supervision in a team-oriented atmosphere.
• Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, supply chain operations, production, QC, and EHS.
• Able to prioritize and decide appropriate course of actions.
• Proven ability to champion change and innovation
• Effective at implementing decisions

The annual base salary for new hires in this position ranges from $126,225 to $210,375 taking into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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