Company description: 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.
What You Will Achieve As a member of the GCP Third Party Quality team, you will work with vendor leads, and relevant site organization stakeholders for third party quality risk management, issues management and general Good Clinical Practice guidance.
The TPQL is responsible for assessing and ensuring that clinical trial third party partners have the appropriate quality systems infrastructure, including a culture of quality and compliance to adhere to Pfizer policies and procedures with all applicable external regulatory requirements relating to GCP including those related to patient safety, data integrity, and protocol adherence as set out in the Master Services Agreement.
As a Senior Manager, your advanced knowledge of the principles and concepts in the discipline and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division.
Your ability to develop and manage plans will facilitate in achieving objectives, interpreting internal and external business challenges and recommending best practices for improvements.
Job description: Identify, evaluate and respond to GCP quality risks related to vendor and site engagement Lead quality discussions with key vendors and sites and present quality point of view at relevant oversight meetings Provide quality oversight reports to appropriate Pfizer management / functions Communicate key quality information (e.g., inspection / audit learnings) across vendors and site entities and serve as quality expert for third parties Validate, monitor and close out GCP-quality-related action plans Evaluates quality performance at an enterprise level to inform continuous improvement of quality risk management Informs site organization relationship owner of quality improvement considerations.
Support QMS09 BPO in the development and implementation of process updates Support Vendor Leads / Business Owners to ensure compliance with functional level vendor oversight requirements Required profile: Must-Have Bachelor's Degree Demonstrate extensive and relevant applicable experience in a similar role within the pharmaceutical industry Applicable pharmaceutical industry experience Robust knowledge in quality areas (i.e.
audit, inspection, compliance, and inspection readiness fields) Demonstrated project management / leadership experience Quality related experience including working knowledge in:Quality and compliance management Root Cause Analysis Risk identification, controls, mitigations, and actions Metrics development and utilization Audit and Inspection conduct and CAPA response process Proficiency in Microsoft Office Suite What we offer: 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.
Lets 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!
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