Senior Manager, GCS Inspection Readiness Lead
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
The GCS Quality Management Group instills concepts of Risk Management and Inspection Readiness through Global Clinical Supply to ensure that clinical trial project work is conducted to internal and external standards and can withstand Regulatory Inspection.
The position includes interaction with a diverse range of internal stakeholders, potentially including representatives from across the Global Product Development (GPD) organization and Medicinal Sciences.
The GCS Inspection Lead is responsible for directing and managing Inspection and Audit Readiness activities for Global Clinical Supply (GCS).
This includes close liaison with Clinical Supply Teams (CST) and PharmSci Quality Assurance colleagues to trigger and facilitate line discussions to ensure state of program inspection readiness at all times. Establishing and maintaining engagement with Global Regulatory Affairs (GRA) Quality COE and Medical Quality Assurance (GCP quality) is critical.
The role requires understanding of GCP and GMP to support the regulatory requirements and needs of different study types, quality management, inspection readiness, audit/inspection process, Clinical trial processes and systems within GCS. Strong organization and communication skills, both written and oral, are critical.
Inspection Readiness Management:
- Proactively ensure that information relevant to inspection and audit readiness are initiated and maintained throughout the conduct of a protocol.
- Initiate inspection readiness tools such as, GPD Inspection Readiness Questionnaire and GCS Inspection Readiness Storyboard and further refine with the CST
- Act as the GCS point of contact with GRA Quality COE Inspection Readiness team, MQA Inspection Management team and PharmSci QA for audit and inspection preparation, response findings and required communications.
- Notify GCS program and functional line SMEs of upcoming audits and inspections
- Share audit and inspection updates with GCS LT
- Coordinate and gather information during Inspections and audits, attend opening, closing, debrief meetings
- Lead meetings to address audit and inspection finding with identified SMEs
- Manage the oversight and updates of the GCS Inspection Readiness SharePoint Site for knowledge management across GCS, i.e., expected and announced audits and inspections, progress of completed work, etc
- Establish and maintain relationship with inspection and audit teams
- Lead trend analysis and lessons learned to identify opportunities and proactively share and manage components relating to GCS
- Use of Spotfire or similar visualization tools in audit and inspection preparations
- Propose enhancements to visualizations to drive continuous learnings and process improvements.
- Develop training and communication to maintain and evolve a culture of quality elements to ensure level of inspection readiness can be maintained.
- Applies knowledge and understanding of the impact a decision will have on a process.
- Assumes responsibilities outside area of expertise having broad reaching effects
- Ownership of GCS Quality Management SharePoint site for knowledge management of compliance and quality information across GCS
- Ensuring compliance with applicable SOPs and Business processes spanning Medicinal Sciences and Global Product Development (GPD) as required.
- Evaluate, propose and lead process enhancements efforts
- Evaluate, propose and lead training enhancements efforts
- Escalate concerns to Head of GCS Quality Management and PharmSci QA related to timelines, engagement, and quality.
- Work across GCS functional lines, Medical Quality Assurance and PS quality to oversee, manage and deliver responsibilities
- Use of data applications to surface, highlight, manage and share information to improve quality across GCS
- Progress technological enhancements in tools used by GCS QM
- Member of GCS Quality Governance boards or teams, including preparation and presentation of materials.
- Develop and lead trending and monitoring in efforts to ensure that the conduct of clinical trials complies with stringent scientific and ethical standards.
- A minimum of a BA or BS is required, advanced degree in relevant field desirable.
- Minimum 9 years of pharmaceutical experience with solid experience in clinical studies, investigational supplies, supply chain, GMP/GCP Quality
- Strong and effective verbal and written communication skills.
- Strong project management, administrative, and technical capabilities
- Technical proficiency/expertise, including skills in use of common desktop tools (MS Word, MS Excel, MS Project, Visio); Office365 and SharePoint; tools for analysis and graphing; reporting (Spotfire); and systems for document management and learning management
- Ability to work independently seeking guidance as needed
- Regulatory inspection experience
- Detailed knowledge of clinical trial processes and relationships
- Knowledge of GCP requirements and applicable SOPs and regulations are required
- Influencing skills
- Attention to detail
- Quality or compliance experience preferred
- Strong scientific background in Life Sciences, Regulatory Affairs, or higher degree preferred
- Strong organizational skills and ability to prioritize multiple projects and meet targeted deliverables and deadlines; strong planning and multi-tasking skills
- Ability to adapt to changing situations and work well under pressure
- Proven ability to function autonomously in a matrix model and in a team environment
- Demonstrated experience in supporting continuous improvement projects.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Travel will be minimal.
May include domestic and international travel to GCS sites
May periodically require working across US, EU, Asia hours to support regulatory activity and/or engagement with global colleagues.
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