(Sr.)/ Manager, QA Document Compliance
Site Name: USA - Maryland - Rockville Posted Date: Sep 23 2021 GSK currently has an opening for a Senior Manager in our QA Document Compliance Department in Rockville, MD. In this role, you'll establish organization and control systems for hardcopy documents and electronic documents. This includes updating and management of the document control archiving rooms, electronic document system and off-site storage facilities. Perform and monitor customer support standards and develop the work team in best business practices. Key Responsibilities: Interpret and apply regulated/GMP documentation requirements to electronic document management systems. Manage VQD system for the site Manage a diverse team Strong customer service skills including the ability to offer solutions to complex problems by thinking out of the box. Strong oral and written communication skills, including group presentations. Work effectively in a cross functional team and manage designated resources (personnel, project) toward accomplishment of department goals. Handle multiple projects and interface with individuals from multiple departments. Work in a fast-paced environment and be able to change directions as needed. Create and or deliver constructive feedback for performance reviews. Support department goals and budget. Deliver and maintain a strong professional business etiquette. Excellent organizational skills, advanced PC skills and knowledge of MS Office. Grow and develop the team to work to their potential. EnsuresL1 Self Inspection procedures for area of responsibility are in place and in use. Participate in a sampling of L1 Self Inspections for the area(s) of responsibility. Trained as an L1 Auditor and participate in >25% of department's L1 Inspections. Support Management Team. Develop GMP processes Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS/BA degree Minimum 4 years of GMP environment experience Preferred Qualifications: If you have the following characteristics, it would be a plus: 2+ years of supervisory experience Demonstrate ability to define best practices for department and drive the adoption of those best practices. Coach and mentor other staff members in all functions of Document Compliance. Manage change on a daily basis as problems arise. Recognize and escalate issues that will jeopardize the patient, environment and business. Support and adhere to safety, patient and company values. Provide support to internal, external and regulatory inspections as required. Must have the ability to interpret and apply regulated/GMP documentation requirements to the document management system. Must be able to work in cross functional teams and make sound business decisions for the department and the work team. Why GSK? Our values and expectations are 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, rigor 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. 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