Director, Gcp Quality Event Investigations

Role Summary

You will manage confirmed GCP Significant Quality Event (SQE) cases through the investigation process including root cause analysis ensuring compliance to ICH-GCP guidelines. You 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 communication regarding the case. You will lead the SQE team in proposing appropriate Corrective and Preventative Actions and that completion of all those are evidenced in documentation as required. You will be responsible for and manage critical quality events/issues and other complex cases and especially those that require presentation to senior leaders as part of the Quality Review Team (QRT).

Key Responsibilities

• Review, develop and deliver training as necessary.
• Act as SQE subject matter expert during regulatory inspections, as necessary.
• Mentor new hires in the onboarding process
• Facilitate a large matrix-team of colleagues through the investigation process, for each quality issue assigned
• Develop an SQE summary with appropriate quality outcomes, which meets defined standards and can be used for a regulatory submission
• Perform quality review and approval of select significant quality events which have been managed by other investigation leads.
• Participate in process improvement initiatives as necessary and drive changes to the business process for case management when the need arises.
• Appropriately investigate each confirmed SQE case including ensuring investigation timelines are met

Basic Qualifications

• Experience leading and coordinating a cross-functional/matrix team, managing to timelines
• Detailed knowledge of clinical trial processes and relationships
• Master’s degree and a minimum of 5 years related experience in a pharmaceutical environment including experience in data management, GCP Quality, GxP Quality, and/or regulatory inspection
• Proficiency with Microsoft Office
• Experience with a continuous improvement DMAIC methodology (e.g., Lean Six Sigma)
• Bachelor’s degree and a minimum of 10 years related experience in a pharmaceutical environment including experience in data management, GCP Quality, GxP Quality, and/or regulatory, or
• Strong written and verbal communication skills
• Knowledge of GCP requirements and applicable SOPs and regulations

Preferred Qualifications

• Proficiency with Veeva Vault and Track-wise database systems

Other Information

This role will interact with multiple roles within the Global Product Development organization, as well members from Compliance, Legal, Product Supply.

This position does not have any direct/indirect reports.

Purpose

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

Quality Assurance and Control