QCC Compliance Lead
GlaxoSmithKline - King of Prussia, PA

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Basic qualifications:
  • BS/BA in Engineering or Life Sciences and 10-15 years of relevant industry experience.
  • Industry experience in assessing and implementing initiatives for regulatory compliance across all aspects of GMP Operations
  • Experience in a quality organization in a GMP setting is required, including experience with quality systems.
  • Working knowledge of cGMP and Regulatory requirement for the development of Biopharmaceuticals as they relate to QC.
  • Experience in Quality Management Systems and harmonization of compliance systems including regulatory audit preparation.
  • Demonstrated ability to work on multiple projects, the ability to focus on the important projects, and the flexibility to adapt to changing priorities.
  • Detail oriented. Able to conduct critical evaluations, generate options, and make recommendations for implementation.
  • Experienced in gap analysis and risk-based decision making.
  • Knowledge in document management practices as they relate to ensuring cGMP compliance to regulations for process development, manufacturing, quality control and equipment validation.
  • Technical understanding and experience with biopharmaceutical production, analytical / quality control, and validation.
Preferred qualifications:
  • Strong interpersonal, organizational, and leadership skills; strong verbal and written communication skills, which result in minimal supervision with maximum business presence.
  • Must be able to interact well with peers, subordinates, and senior personnel in multidisciplinary teams involving scientific, quality, and operational disciplines.
Details:
AUTHORITY AND RESPONSIBILITIES OF JOB: (Description of Role/Position)
  • This key role will be responsible for assisting in the oversight of compliance associated with the manufacture and release of Clinical Trial Material for Biopharm R&D GMP Operations.
  • Position will involve participating in /supporting a new organization to support product release testing for both Early and Late Phase GSK Biopharm assets and for ensuring alignment of biopharmaceutical compliance systems with the established R&D policies
  • Position involves extensive matrix working both internally and externally.
  • Work with other departments within GMP Operations to ensure appropriate quality systems are in place and followed to ensure cGMP compliance.
  • Work within R&D to ensure alignment of local policies with Governing R&D QMS policies.
  • Engage Quality Assurance organization to ensure cGMP compliance and maintenance of system infrastructure.
THE SPECIFIC DUTIES OF THE ROLE/POSITION:
  • Lead, coordinate, and support the GMP Ops Compliance Team Meetings.
  • Assist as needed to support the Risk Management process.
  • Responsible for leadership and support of compliance-related initiatives for Biopharm R&D GMP Operations, including inspection-readiness activities, coordination of regulatory inspections and internal audits, and implementation of quality guidelines.
  • Key liaison from Biopharm R&D GMP Operations to Regulatory, Quality Assurance, and above-site Quality organizations.
  • Assist in the development of philosophies and strategic documents defining GMP Operations’ quality systems and work processes.
  • Remain informed of current FDA, EU, and industry standards and ensure their consideration and expression in GMP Operations’ ways of working.
  • Maintain compliance with all corporate policies, guidelines and SOPs.
  • Responsible for leading investigations and defining appropriate CAPA.
  • Provide training and guidance on compliance-related matters to personnel across GMP Operations.
  • Lead the Compliance team review for submissions and data checks.
  • Assist with Quality Trends and metrics
  • Participate on QMS integration activities with the balance of R&D and GMS to ensure harmonized and compliant quality management systems for implementation within the biopharm CMC space.
  • Participate in implementation of business work processes and ensure alignment with process/method capabilities.
  • Support cGMP systems to include change control, COA generation and review, records management, equipment/process/computer validation, training and competency program and documentation, SOPs, process improvement, investigation process improvement, submission review, and data review.
  • Provide strategy and implement any necessary changes to keep in compliance with applicable regulations and guidelines.
  • Lead compliance through shop floor presence and performance of area walkthroughs.
  • Suggest and support opportunities for improvement within GMP Operations and BioPharm.
  • Other duties as needed.
Contact information:
You may apply for this position online by selecting the Apply now button.

GlaxoSmithKline - 2 years ago - save job - block
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GlaxoSmithKline plc (GSK) is a global healthcare group, which is engaged in the creation and discovery, development, manufacture and...