- 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.
- 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.
AUTHORITY AND RESPONSIBILITIES OF JOB: (Description of Role/Position)
THE SPECIFIC DUTIES OF THE 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.
- 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.
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GlaxoSmithKline - 2 years ago
GlaxoSmithKline plc (GSK) is a global healthcare group, which is engaged in the creation and discovery, development, manufacture and...