Merck Sharp
& Dohme Corp , MSD- Manager Regulatory Affairs CMC Pharmaceutical/Biotechnology , Small
Molecule industry
Job
Description
As part of
the Global Regulatory Affairs & Clinical Safety (GRACS) CMC Change Control
& Dossier Management team, the Small Molecule Change Control Lead will be
responsible for administration of commercial manufacturing change controls from
initial authorization throughout the project’s lifecycle to completion. The candidate
serves as the primary point of contact for the Business Process Team to the
Small Molecule CMC Team to develop and manage operational activities associated
with the commercial Small Molecule Change Control. The position is expected to
routinely update and report to Small Molecule Leadership on project status and
issues of active change controls.
The candidate
is expected to have prior experience in quality and quality management systems,
knowledge of CMC Regulatory documentation (dossier structure, filing strategy),
and an understanding of large molecule commercial manufacturing process. The candidate will be required to utilize
principles for effective project management and business process design to
facilitate meetings and resolve bottlenecks in the progress of commercial Small
Molecule change controls.
Primary
Activities:
Collaborating
across Global Regulatory Affair and Clinical Safety (GRACS) CMC functional area
(site CMC, International CMC, Project Management Organization (PMO), Business
Process Team etc.) and Our Manufacturing
Division partners to ensure commercial change control projects and related
activities are on track per program objectives for the Small Molecule Franchise
Aligning,
monitoring and reporting commercial change control project status for the Small
Molecule Franchise
Applying
knowledge of scientific and quality principles, regulatory requirements, change
control standards, and GMP practices to optimize the workflow for the
commercial Change Control
Applying
principles of project management to plan and perform appropriate work during
each phase of the projects process
Identifying opportunities for innovative
improvements to enhance communication, planning, organization, and daily
operations to ensure timely tasks delivery
Applying
quality, Change Control (GCM Trackwise) and Health Registration Management
(HRM) systems knowledge to support daily operational needs
Collaborating
with Business Process Lead and the Small Molecule Franchise to develop and
deliver IT enabled solutions for progression of change controls from
authorization to completion
Demonstrating
capabilities of critical thinking to understand change control dependencies and
intricacies and articulating logical pragmatic solutions
Leading small
cross-functional teams to meet project milestones and demonstrating leadership
necessary to build and maintain high quality change control assessments
Qualifications
Education
minimum requirement
Minimum of 5
years experience with BS in Science or Engineering. Experience should be in
pharmaceutical/biotechnology or Small Molecule industry with experience in a
quality, or compliance, or Regulatory role (e.g., manufacturing, process
development, analytical, quality assurance).
Effective
communication, negotiation, problem-solving, and interpersonal skills with a
working knowledge of project management
to perform job responsibilities.
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