Manager, Steriles Biopharm Quality Assurance
To perform the quality assurance activities and quality oversight of the GMP functions performed by the Biopharm Product Development and Supply organization.
• Provide input into the development of strategy, policy, group objectives and processes in Product Quality Pharma R&D and with business partners
• Assure products meet regulatory requirements and that they conform to regulatory submissions.
• Interact with regulators and/or industry experts to represent GSK interests
• Interpret and apply regulations/policies to unique and often complex issues.
• Manage routine audits/assessments as well as multiple projects of high priority including regulatory inspections and high risk non-compliance issues.
• Manage resource (may include budgets), priorities, schedules and/or projects to assure delivery of group objectives.
• Lead a project, program or team activities which may include GxP.
• Contribute to an environment that optimizes employee productivity and adds value.
• Develop group skill sets and knowledge base to meet the needs of a changing environment.
• Direct the activities of one or more direct reports or lead a matrix team or business process.
• Actively engage in risk management activities to identify effective risk management strategies including the escalation of risks and their solutions.
• Act as a coach, mentor or trainer to develop others.
• Represent the group as a business contact or on a quality forum/council.
• Proactively identify, communicate and monitor business/regulatory changes that could impact on quality or compliance across Pharma R&D.
• Provide suitable recommendations/mutual solutions that show measurable improvement and added value to internal/external customers.
• Communicate and interact at various levels internally and externally to GSK.
• Develop internal/external networks to communicate with key stakeholders.
• Engage with the business in strategic/operational decisions on behalf of the group.
• Promote a high level of GMP awareness and compliance in business partner areas and project teams.
• Approve GMP documentation, including Standard Operating Procedures validation documentation, change controls and other controlled documents from business partner areas.
• Approve Standard Operating Procedures pertaining to Quality Assurance and business partner GMP systems.
• Manage internal assessment schedule and ensure compliance.
• Approve investigations, such as Quality Investigations, customer complaints and vendor complaints and make recommendations for corrective and preventative actions, and to follow up on the implementation of those recommendations.
• Lead the preparation and hosting of GSK corporate and regulatory inspections and responding to audits and/or inspections.
• Approve GxP training for delivery to business partners.
• Ensure 3rd party management activities, including audit of suppliers and contract resource organizations, are performed utilizing third party assessment procedures.
• Generate, review and approve batch and packaging record templates.
• Conduct review of Completed manufacturing and or Packaging records.
• Perform material release activities (US Only)
• Generate and approve relevant release documentation
• Provide project support including pre approval audit activities.
• Bachelor's degree in Scientific or Healthcare discipline or equivalent.
• A broad scientific/pharmaceutical industry background with 2 years or more in Good Manufacturing Practices (GMP) Compliance and/or Quality Assurance (QA) required.
• In depth knowledge of global, regional and national regulatory requirements and regulations.
• Detailed knowledge of the pharmaceutical industry drug development and clinical research processes
• Have a demonstrated and sound working knowledge with detailed understanding of the approach and perspectives of regulatory agencies
• General understanding of other regulated (GxP) areas
• Has demonstrated basic project management skills, handling several projects and programs, covering different indications and stages of development
• Demonstrated verbal, written and presentation skills
• Ability and desire for frequent travel (approximately 25%)
• Supervisory experience directing the activities of one or more direct reports and/or lead a matrix team or business process.
• Detailed understanding of compliance requirements for sterile manufacturing
GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.
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