Site Data Integrity and Risk Management Lead

Company: GSK Poland
Location: Saint Louis
Posted on: February 23, 2021

Job Description:

Site Data Integrity and Risk Management Lead

• St. Louis, Missouri
• Quality
• 279101 Serve as Data Integrity Lead within the St Louis site. Responsible for leading the implementation of the data integrity culture and strategy and data governance framework and processes for the site and ensuring compliance with all applicable regulatory requirements at the system level. Serve as Risk Management Process Owner (RMPO) with the St Louis site. Responsible for ensuring the risk management principles are in place and in use and overall governance of the system. Successfully carry out the Key Responsibilities in an organized manner in accordance with the priorities set forth by the Site Quality Head. Focus on the fulfillment of site objectives and ensure the implementation of the corporate requirements of the Quality Management System. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Data Integrity:
  • Oversee site compliance with the Quality Management System and regulatory requirements pertaining to data governance, including the development of indicators that monitor data governance processes and performance at the Site level
  • Develop and implement robust data governance practices, including routine management review of key data integrity metrics and risk model indicators, establishing data ownership and enhancing data analytics for the key risk area of Data Integrity
  • Provide support in the event of internal, external and regulatory audits, including potential direct interaction with regulatory agency officials on queries related to data integrity
  • Generate communication and work plans in order to ensure the prevention and detection of Data Integrity events
  • Participate in the gap analysis of the policies and procedures associated with Data Integrity, ensuring alignment of local SOPs with corporate requirements. Also, serve as the site's SME and primary point of contact on regulatory intelligence and engagement activities related to data integrity and data governance. Ensure site awareness and mastery of new requirements is complete and timely.--
  • Continuously assess employee data integrity performance and understanding through internal inspection, training effectiveness evaluation, GEMBA and process confirmation.
  • Gain deep understanding of data integrity incidents and ensure corrective and preventative actions are comprehensive and robust
  • Lead the program of Data Quality Culture at the site, taking a strong and visible role in embedding true commitment to data integrity throughout the site. Advocate to drive implementation of changes which will make compliance easier.
  • Manage the assignment of roles and responsibilities for the review, approval and execution of plans necessary to meet data integrity standards. This includes coordination of the evaluation and, where required, remediation of new and existing electronic systems (IT, analytical, and production) to assure compliance with applicable requirements.
  • Establish and lead an internal site network of DI champions and actively participate in the multi-site DI Community of Practice
  • Ensure robust and systematic risk management process pertaining to quality, safety and business supply is in place and in use at the site, and operated in compliance with GSK expectations.
  • Increase risk risk management capability (identification, description, rating and mitigation) is developed at all levels of the organization, including development of risk writing capability across site.
  • Attend and represent the site at regional (quarterly) RMCB (Risk Management Control Board) meetings. Be able to provide an accurate status of site risk management position and act as ai liaison between site and the regional forum.
  • Prepare for and chair monthly site RMCB meetings to a fixed agenda.
  • Manage the site RMS (Risk Management System) ensuring risk, mitigation and action owners are held responsible for delivering on risk management commitments. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:
    • Bachelor's Degree
    • 5 years of experience in the Pharmaceutical Industry in Quality Assurance areas or area related, including a position of authority in decision making and management of documentation and / or IT.
    • Experience with Systems Operation and Good Documentation Practices and Data integrity
    • Experience in project management Preferred Qualifications: If you have the following characteristics, it would be a plus:
      • Experience in ------Validations, Quality, Engineering, Production and / or any other functional area in which they have acquired knowledge in multiple quality processes and interfaces with multiple functional areas
      • Knowledge of Good Manufacturing Practices standards, Good Laboratory Practices, Risk Management as it applies to the Pharmaceutical industry, Policies, Corporate GlaxoSmithKline Quality Management System, Safety, Health and Environment of GlaxoSmithKline, Systems operation and Management, risk management and local regulatory requirements and international.
      • Knowledge of Documentation and Electronic Systems that generate and manage GxP processes.
      • Knowledge of Risk Management software platforms
      • Interpersonal and communication skills (teamwork, effective negotiation, resolution of problems, decision making, critical aptitude, ability to interact with personnel from other areas, other disciplines and with external personnel (technical advisers, system providers, consultants for systems, among others). Why GSK? Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
        • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
        • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
        • Continuously looking for opportunities to learn, build skills and share learning.
        • Sustaining energy and well-being.
        • Building strong relationships and collaboration, honest and open conversations.
        • Budgeting and cost-consciousness. *This is a job description to aide in the job posting, but does not include all job evaluation details. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site. This is our global website, intended for visitors seeking information on GSK's worldwide business. Our market sites can be reached by visiting our market selector .

Keywords: GSK Poland, St. Louis , Site Data Integrity and Risk Management Lead, Professions , Saint Louis, Missouri