Center Director managing Older Adult Centers at Greenwich House. Overseeing daily operations, developing programs, and ensuring compliance with regulations while building community relationships.
About the role
- Director of Product Quality Management leading complaint investigations and ensuring compliance within the PQM Team. Responsible for technical expertise and compliance in the pharmaceutical sector.
Responsibilities
- Act as complaint investigation process SME by providing technical, quality and compliance expertise for investigation, documentation and resolution/closure of Product & Signal Complaint Investigations within the PQM Team.
- Ensure that deviations & complaints are timely and properly investigated such that the internal and external customer expectations are met.
- Lead the application and integration of structured root cause problem‐solving methodologies to (Fishbone, 5 Whys, etc.) to all Product & Signal Complaint Investigations identified through PQV established processes.
- Act as process SME for Nonconformances and/or CAPAs raised as part of Product & Signal Complaint Investigations identified through PQV established processes.
- Work directly with PQIs/PQOs and device engineers’ teams to ensure product knowledge of Synthetics, Proteins and Cell and Gene therapies are core to all end of end Root Cause Analysis investigations.
- Work as part of a cross functional Investigation team to drive critical thinking and end-to-end accountability of product and signal complaint investigations.
- Work with the organization to identify resources to support RCA investigations and resulting actions.
- Develop and maintain proficiency in the COMET.
- Monitor nonconformance and CAPA deliverables / timelines for functional area by running reports, communicating upcoming deadlines to record owners and escalating concerns to management as appropriate to actively drive compliance.
- Escalate any issues, as needed, to the PQM CAPA Review Board and attend the meetings if required.
Requirements
- Requires a BA/BS in Science/Engineering.
- Master’s degree in life science study or equivalent experience is preferrable.
- Minimum of 7 years’ experience previous Pharmaceutical Industry experience is required, with at least 7 years of GXP experience within clinical research and development and/or quality assurance.
- Up-to-date knowledge and in-depth understanding of relevant pharmaceutical legislation, legislation related to cGMP regulations (Eudralex, ICH, Ph.Eur., USP, etc) at global, regional and national levels.
- Strong analytical thinking, decision-making and leadership skills.
- Excellent verbal and written communication skills to negotiate and communicate with customers and partners.
- Able to apply appropriate risk assessment strategies to manage business & compliance priorities and translate them into actionable items and an action plan.
- Fluent in English.
- Proficient in Microsoft Office applications.
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