Quality Investigation Lead
3 months ago
Posting closing date: October 16 2024
Date de fin d’affichage : le 16 octobre 2024
Status : Regular, full-time
Statut :Régulier, temps plein
(Français à suivre)
Why Patients Need You
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.
Role Summary
The Global Clinical Supply (GCS) Inspection and Risk Management Group instills concepts of quality and compliance throughout GCS to ensure that clinical trial project work is conducted to internal and external standards and can withstand Regulatory Inspection. This includes ensuring quality investigations are conducted efficiently and completely.
The position includes interactions with GCS colleagues at various levels, QA and other Pharmaceutical Science lines.
The GCS Quality Investigation Lead (QIL) will be accountable for managing/owning quality investigation records through initiation, the investigation process including root cause analysis including Human Performance, to record closure. This encompasses gathering relevant details and writing the investigation. The Quality Investigation Lead will ensure the investigations are conducted thoroughly, within required timelines and to compliance requirements including ensuring the adequacy of root cause analysis and appropriateness of communications and resulting actions.
The Quality Investigation Lead will lead the investigation team in the development of appropriate Corrective and Preventative Actions (CAPA) and assign completion dates to action owners that ensure actions are progressed quickly to completion, including creation of Change Management records as required.
How You Will Achieve It
- Ensure that each record is investigated appropriately ensuring investigation timelines are met and that appropriate pre-work is done to enable an investigation with appropriate quality outcomes including effective and well written documentation practice.
- Independently own and drive records including those of highest complexity.
- Influence actions in matrix environments ensuring investigation details are complete from SMEs.
- Perform activities in compliance with SOP and the Veeva Vault system procedures or equivalent system.
- Independently uses root cause tools to drive investigations to appropriate closure including remediations as required.
- Manage extension requests actions and CAPA effectiveness checks so that approvers are given adequate time to approve within appropriate timeperiod and prior to due date.
- Facilitate across GCS functional lines and QA to investigate, document and drive to accurate and effect record closure.
- Appropriately escalate concerns to leadership and designated quality forums regarding the progress of an investigation or implementation of appropriate CAPAs so that concerns can be addressed and resolved in a timely manner.
- Develop and present on findings, trends, issues or metrics.
- Lead or participate in broader line efforts such as process enhancements.
- Provide guidance and advise for non-owned investigation activities.
- Support of audit and regulatory activity as necessary.
Must-Have
- A minimum of a BA or BS is required.
- Minimum 5 years of pharmaceutical experience with solid experience in clinical studies, investigational supplies, supply chain, or GMP/GCP Quality
- Technical or equivalent writing skills are a key component
- Ability to manage multiple complex projects and has business acumen
- Excellent interpersonal effectiveness and strong written and verbal communication skills
- Attention to detail
Nice-to-Have
- Ability to progress work activities independently
- Working knowledge of clinical trial processes and relationships
- Knowledge of GCP requirements and applicable SOPs and regulations
- Knowledge of GMP requirements and applicable SOPs and regulations
- Strong project management, administrative, and technical capabilities
- Quality or compliance experience preferred
- Scientific background in Life Sciences, Regulatory Affairs, or higher degree preferred
- Training and proficiency in root cause analysis methodology preferred
We are proud to offer employees a flexible working model that is grounded on empowering colleagues to design their workdays so that they can maximize their productivity, enhance their work-life balance and support a way of working that fosters innovation and patient-centricity. Currently, our employees are expected to be on-site 2.5 -3 days per week blending on-site collaboration and connection with off-site remote working when it makes business sense to do so.
- The annual base salary for this position ranges from _$89,400 to $149,000_._
- Leader - Enquêtes sur la qualité
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