The Senior Manager QA Process Lead position is an individual contributor that has responsibility for oversight and delivery of the Internal Process Compliance function activities. This position and department will be aligned as partners to the functional areas of the Clinical Development and Commercialization Services (CDCS) business to ensure appropriate quality/compliance oversight and solution partnering. Driving compliance excellence within the organization through execution of key activities, improvement methodologies and governance forums. Of importance are the requirements to lead, strategize, partner and influence across various functions and locations.
Provides regulatory compliance and quality assurance advice, guidance and support to internal CDCS teams and functions and collaborating with other internal stakeholders (e.g; Legal) for proactive interactions and quality management.
This position can be remote-based.Education/Qualifications:
- A minimum of a Bachelor's Degree in Life Sciences preferred (or equivalent Life Science experience)
- Experience may be substituted for education.
- 10 years in regulatory environment (experience in GXP roles)
- Experience & regulatory expertise of industry quality systems/standards
- Ability to interpret applicable regulations/standards
- Ability to analyse and interpret data in order to lead process improvement initiatives
- Ability to communicate and negotiate with internal stakeholders effectively
- Ability to distill critical information
- Ability to effectively lead project teams to implement change
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