ESOQ Contractor Quality Lead, Manager

Use Your Power for Purpose

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients.  

What You Will Achieve

As a key Quality partner for Pfizer’s external manufacturing network, you will be responsible for ensuring product quality, compliance, and continuous improvement across a portfolio of Contract Manufacturing Organizations (CMOs) and suppliers.

In this role, you will:

• Manage all aspects related to product quality and compliance for a portfolio of external contract manufacturers and suppliers delivering materials and/or products to Pfizer, in accordance with established procedures.

• Assess the quality of external suppliers’ products, manufacturing processes, and related documentation, ensuring product specifications are met and quality systems are maintained.

• Support internal and external partners with auditing activities related to ESOQ operations and contractor portfolios, including RQA audits and regulatory inspections, as applicable.

• Support internal and external partners with Compliance Assessments to ensure ongoing GMP/GDP adherence.

• Manage vendor risk by implementing Quality Improvement Plans and supporting risk assessments, Quality Review Teams (QRTs), and Quality Action Notices (QANs), as required.

• Support onboarding activities for new CMOs and product launches within the assigned portfolio.

• Support offboarding activities for exiting CMOs, products, or SKUs within the portfolio.

• Make product quality decisions by leveraging comprehensive knowledge of Quality and Manufacturing principles, prior work experience, and technical expertise, while ensuring compliance with global regulatory and Pfizer requirements.

• Influence quality decision‑making in alignment with industry standards and Pfizer requirements.

• Provide Quality leadership within cross‑functional Virtual Site Operating Teams (VSOTs).

• Partner with colleagues to develop, review, and negotiate Quality Agreements.

• Review and approve Annual Product Reviews (APR), Product Quality Reviews (PQR), and relevant product stability reports.

• Perform batch disposition endorsement in accordance with Pfizer requirements.

• Identify, develop, and implement continuous improvement initiatives related to ESOQ processes to ensure compliance with evolving internal and external standards.

• Ensure accurate tracking, documentation, and escalation of all required quality‑related actions in the relevant systems.

• Lead and support complex investigations, market complaints, and risk assessments for products within the portfolio; raise NTMs and engage SMEs as needed.

• Provide performance metrics and reporting for key quality performance indicators.

• Work independently, receiving guidance primarily on unusual or complex issues.

• Build, maintain, and further develop strong relationships with key internal and external stakeholders.

Here Is What You Need (Minimum Requirements)

• Minimally Bachelor of Science Degree, Pharmacy, Engineering, or related technical discipline

• Minimally 5 years’ experience 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.

• Experience with external suppliers/contractors.

• Advanced computer skills for MSOffice and enterprise systems such SAP, QTS, eQMS

• Proficient in English and technical writing

• Strong verbal, written communication, and presentation skills

• Demonstrated personal leadership to work in virtual teams and cross functional projects/initiatives

• Demonstrated experience managing complex quality and compliance activities

• Problem solving attitude and open to innovation

• Demonstrated managerial/organizational skills

• Strong critical thinking and proactive, persistent approach

• Good organizing and planning skills and a high sense of urgency

• Demonstrated ability to act and work independently, to take initiative and to report items as required to line manager

• Demonstrated knowledge of US, European and global cGxPs, compliance issues, inspectional trends, industry quality assurance practices

• Proven leadership/facilitation skills and being able to involve several levels of an organization to successfully meet the objectives

• Demonstrated experience in pharmaceutical manufacturing activities (API, DP, Biotech, Oral Solid Dosage, Aseptic) applicable to the role

• Demonstrates the ability to influence and collaborate with diverse stakeholders

Bonus Points If You Have (Preferred Requirements)

• Experience using common AI tools, including Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

• OPEX qualifications (green belt/yellow belt)

 
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!

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Quality Assurance and Control