global clinical supply quality Investigation leadPfizer

ROLE SUMMARY
The GCS Quality Management Group instills concepts quality and regulatory compliance through Global Clinical Supply 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 primarily with GCS colleagues at various of levels, PharmSci QA and potentially, other Medicinal 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 and PHP, to record close. 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 Planned Temporary Deviations as required.
RESPONSIBILITIES:
Ensure that each record is investigated appropriately including 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.
Record complexity will be of moderate level, higher complex records may be assigned with mentor or manager oversight.
Perform activities in compliance with SOP and QTS record/system procedures or equivalent system.
Trained in using root cause tools to drive investigations to appropriate closure including remediations as required with oversight and support.
Trained in using Pfizer Human Performance tools with oversight and support.
Appropriately escalate concerns to Quality Management leadership and designated quality forums regarding the progress of an investigation or implementation of appropriate CAPAs so that it can be addressed and resolved in a timely manner
Responsible for managing extension requests actions and CAPA effectiveness checks so that approvers are given adequate time to approve within appropriate time period and prior to due date.
Work with mentors and manager to facilitate cross GCS functional lines and QA to investigate, document and drive to accurate and effect record closure.
Support of audit and regulatory activity as necessary
Support the scheduling management of record due dates looking across GCS and QA organization to reduce due date bunching over holidays and year end.
Participate and contribute to broader line efforts such as process enhancements.
Use of Spotfire or similar visualization tools
Attend GCS Quality Governance meetings as needed
Qualifications:
A minimum of a BA or BS is required.
Minimum 3 years of pharmaceutical experience with solid experience in clinical studies, investigational supplies, supply chain, GMP/GCP Quality
Technical or equivalent writing skills are a key component
Preferred Qualifications:
Ability to progress work activities with oversight
3-8 years of pharmaceutical experience with solid experience in clinical studies, investigational supplies, supply chain, GMP/GCP Quality
Working knowledge of clinical trial processes and relationships
Knowledge of GCP requirements and applicable SOPs and regulations
Project management, administrative, and technical capabilities are required,
Strong and effective verbal and written communication skills
Attention to detail
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
Project management, administrative, and technical capabilities
Strong organizational skills and ability to prioritize multiple projects and meet targeted deliverables and deadlines
Ability to adapt to changing situations and work well under pressure
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 engagement with global colleagues across time zones (e.g. early morning and evenings)
Work Location Assignment: On Premise
#LI-PFE
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Research and Development
#LI-PFE
Pfizer

Makati City, Metro Manila
Permanent
Full-time