Quality Assurance Senior Associate

Use Your Power for Purpose
Every day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.
ROLE SUMMARY
This Quality position is considered a global position and reports into the Global Clinical Supply Quality Assurance (GCS QA) Lead for Clinical Complaints and Investigations, within Pharm Sci Operation Quality (PSOQ) responsible for supporting Pharmaceutical Sciences.
This Senior (Sr) Associate Quality Assurance position will primarily support the GMP/GCP interface specialty team within GCS QA and may lead to opportunities to move or rotate into the wider areas of GCS QA in alignment with Development Planning and/or Business need.
This Sr Associate will be responsible for leveraging strong and collaborative partnerships with colleagues across PSOQ, Global Clinical Supplies / Clinical Development Operations, other Worldwide Research and Development organizations and PGS to support the management primarily for the following areas: Clinical Complaints and Investigation management.
In addition, would be required to support Inspection/Audit readiness, data analysis and development and management of Spotfire and SharePoint platforms, also responsible for developing and enhancing processes to continuously improve and streamline existing quality processes to support activities, with knowledge and skills contributing towards the goals and objectives of the team.
ROLE RESPONSIBILITIES
Perform a range of duties within the GCS QA Clinical Complaints and Investigation team, associated with Quality Management Systems oversight, Quality Operational role for Clinical Complaints, Investigations and may be required to support Inspection/Audit readiness , for which Duties may include some or all the following, at various times, depending on experience and job assignment:

• Responsible for leading /supporting the author, review, and approval of related GMP deviations & product quality investigations and provide oversight to the timely closeout and effective investigation of clinical supplies, CAPA effectiveness, trending, and metrics.
• Responsible for leading /supporting the author, review, and approval of clinical complaints, ensuring timely closeout, providing complaint management oversight for trending and metrics, CAPA effectiveness.
• Escalate issues as appropriate to the Quality Assurance Lead in a timely manner, with responsibilities for generating Notifications to Management/ Issue Escalations.
• May be required to participate/ support PSQRT/AQRT activities and outcomes.
• Audit/Inspection Support, collaborate with Global Clinical Supply, Pharm Sci Operation Quality and other groups in Worldwide Research and Development to support regulatory agency inspections, Regulatory Quality Assurance and Internal audits / Inspections.
• Applies skills and knowledge to Support continuous improvement in the support model and management of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) activities for the investigational medicinal product process through partnerships with Global Clinical Supply and the wider Clinical Development Operations.
• Support the development and management for Spotfire and SharePoint platforms, using these for data analysis, team documentation repository, plus as a communication tool.
• Takes appropriate risks to Streamline compliance and simplify procedural and other requirements to ensure ease of following program requirements.
• Able to operate independently in ambiguous situations.
• Ensure effective internal networking to develop and maintain business partner relationships with internal colleagues.
• Takes responsibility for a portion of the Team's milestones/deliverables.
• Utilize and share learnings from audits/inspections to advance inspection readiness.

Here Is What You Need (Minimum Requirements)

• Preferred bachelor's degree (B.S.)
• 3 + Years' experience
• Relevant work experience in a cGMP pharmaceutical Environment
• knowledge of cGMP regulations and the principles/concepts of relevant quality systems and regulatory compliance.
• Comprehensive and broad knowledge of quality systems.
• Demonstrated experience in supporting continuous improvement projects.
• Proven leadership, accountability, and demonstrated excellent interpersonal, listening, communication, negotiation, influencing, organizing and problem-solving capabilities.
• Proven ability to function autonomously in a matrix model and in a team environment.
• Proactive approach and strong critical thinking skills

Bonus Points If You Have (Preferred Requirements)

• Knowledge of GCP regulations, principles, and concepts
• Quality Mindset
• Computer skills in MS Office applications and a good understanding of enterprise systems such as Quality Tracking System, eQMS, and Documentum platforms

Work Location Assignment: Hybrid
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