ROLE SUMMARY
The Asset Quality Lead (AQL) is responsible for driving GCP Quality by maintaining 'quality' line-of-sight for assigned clinical trial programs/protocols. With this focus, the AQL role brings deep knowledge of GCP quality and risk management principles to asset and study teams. In partnership with the cross functional study team and functional lines in Clinical Development & Operations, the AQL will ensure program and study level quality oversight, drive quality risk management and inspection readiness activities and will be instrumental in ensuring that asset and study level information is appropriately incorporated within the GCP QMS. The AQL is the point person to the cross functional study team and other relevant stakeholders for quality risk management, quality issues management and general GCP guidance.
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ROLE RESPONSIBILITIES
Asset-Level Quality Oversight
• Provide input and support to asset-assigned AQLs to ensure clinical development plan strategy and asset-level risks are incorporated into study and asset-level risk management and oversight to support study data quality
• Utilize quality measures/data to monitor study quality and identify potential risks, quality trends, and support state of quality reporting
• Communicate key quality information across study teams and serve as GCP quality expert to study teams
• Monitor submission risk and flag major risks for Category Quality Head review
Study-Level IQMP Development and Oversight
• Oversee study-level quality risk management activities, including driving IQMP development/maintenance and QTL implementation by ensuring that quality metrics are monitored and that quality deviations are identified and addressed in a timely and appropriate manner
• Develop and present quality point of view at governance and portfolio related meetings
Inspection Readiness and Preparation
• Provide Study Team Inspection Readiness (IR) guidance and support; lead teams through pre-submission IR deep-dive and storyboards
REQUIRED SKILLS, EXPERIENCE AND QUALIFICATIONS
A scientific or technical degree is preferred. In general, candidates for this job would have the following levels of experience:
• BS or MS/MBA with proven/significant experience or equivalent
• Ability to build strong network/knowledge/relationships with internal/external stakeholders
• Advanced knowledge, experience and expertise in ICH GCP, clinical trial development, and operational GCP quality management disciplines such as, quality and compliance assessments, quality assurance, CAPA management, deviation management, root cause analysis, audit and regulatory inspection process, and/or inspection readiness.
• Familiarity with the relevant key therapeutic area(s)
PREFERRED QUALIFICATIONS
• Advanced clinical trials experience, especially operational processes and/or systems.
• Strong interpersonal skills, ability to influence, engage leaders and ability to establish and maintain excellent working relationships across lines in a matrix organization
• Experience of working on global initiatives or project teams.
• Appreciation of diverse needs of different regulatory requirements of various sites and countries
• Strong knowledge of regulations in order to assess GCP situations and to coordinate resolution activities across partner lines
• Quality related experience including working knowledge in areas of:
o Quality and compliance management, QC
o Root Cause Analysis
o Metrics development and utilization o Audit and Inspection conduct
o CAPA development and response process
o Inspection Readiness
o Project/initiative coordination and management skills
• Spotfire and Excel skills/experience
• Knowledge of Pfizer SOPs and quality management processes
ORGANIZATIONAL RELATIONSHIPS
Partners with key stakeholders such as Clinical Development & Operations, RQA, Global Biometrics & Data Management, Global Clinical Supply and BPOs.
The closing deadline for applications is October 15th.
All applicants must have the relevant authorisation to live and work in their home country (UK, Canada, Greece as applicable).
A site based role, our flexible working policy applies.
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.
DisAbility Confident
We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!
Quality Assurance and Control