ROLE SUMMARY
Reports to ESOQ Team Leader (Site Quality Operations Lead)
Actively contributes as part of the External Supply Operations Quality T2 structure to ensure that Pfizer's network of External suppliers / CMO's / partners are supported to deliver high quality products, on time, and in compliance with all established standards and agency guidelines.
ROLE RESPONSIBILITIES
* Managing all aspects related to product quality or compliance for a portfolio of external contract manufacturers and suppliers that supply product(s) to Pfizer according to established procedures.
* Assess the quality of external supplier's products, processes and related documents while ensuring the product specifications are met and quality systems are maintained.
* Supporting internal and external partners with auditing activities related to ESOQ activities, or activities at a portfolio of contractors - (RQA or regulatory audits) as applicable
* Supporting onboarding activities of new CMO's or product launches within the portfolio as applicable.
* Make product Quality decisions leveraging comprehensive knowledge of Quality/Manufacturing principles, prior work experience and concepts in other technical areas while ensuring compliance to global regulatory and Pfizer requirements.
* Have the ability to influence quality decision making in line with industry and Pfizer requirements
* Identify, develop and implement continuous improvement initiatives related to ESOQ processes to ensure compliance with the latest internal and external standards.
* Ensuring the adequate tracking and documentation of all required quality related actions in the relevant system(s) and ensuring that all required escalation processes are followed.
* Leading and supporting complex investigations / risk assessments in support of products within your portfolio
* Working independently and operating with minimal supervision, interacting with high levels of management both at contract manufacturers and within Pfizer.
* Building, maintaining and developing relationships with key stakeholders, both internal and external to Pfizer.
BASIC QUALIFICATIONS
* Minimally Bachelor of Science Degree, Engineering, or related technical discipline
* Minimally 5 years experiences in Pharmaceutical or Medical Device Quality Assurance roles with direct responsibility for product quality decisions and /or 10 years' experience in the pharmaceutical or medical device industry.
* Advanced computer skills for MSOffice and enterprise systems such SAP, QTS, Vault, Documentum platforms
* Proficient in English
* Strong technical writing skills
* Strong verbal, written communication, and presentation skills
* Demonstrated personal leadership to work in virtual teams and in cross functional projects/initiatives
* Is diplomatic, clear & succinct in communication with internal and external stakeholders
* Demonstrated experience managing complex quality and compliance activities
* Demonstrated managerial/organizational skills
* Takes initiatives and is proactive, persistent
* Good organizing and planning skills and a high sense of urgency
* Demonstrated ability to prioritize work, to act and work independently and to report items as required to line manager
* Demonstrated knowledge of US, European and global cGMPs, compliance issues, inspectional trends, industry quality assurance practices
* Demonstrated technical know how
* Proven leadership/facilitation skills and being able to involve several levels of an organization to successfully meet the objectives.
PREFERRED QUALIFICATIONS
* Master's degree and + 10 years relevant pharmaceutical experience.
* Demonstrated experience in pharmaceutical manufacturing activities (API, DP, Biotech, Oral Solid Dosage, Aseptic) applicable to the role
* Experience with external suppliers/contractors
* Candidate demonstrates the ability to influence and collaborate with peers
Work Location Assignment: Hybrid
CLOSING DATE 12 OCTOBER 2025
Additional Information
* In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.
* Please note there is no relocation support available for this position
How to apply
* Make a difference today, all suitable candidates should apply with CV below. We are looking forward to hearing from you
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.
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 Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here
Quality Assurance and Control