About The Position

This is a secondment position for 12-18 months. 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.

Requirements

  • BA/BS with 6+ years of experience; OR MBA/MS with 5+ years of experience; OR PhD/JD with 1+ year of experience; OR MD/DVM with any years of relevant experience.
  • Experience supporting or leading Quality audits and developing/managing remediation plans.
  • Relevant pharmaceutical experience including previous Quality Assurance experience conducting a broad range of audits and vendor management activities.
  • Extensive experience with Quality Agreements.
  • Broad knowledge of relevant regulatory current Good Manufacturing Practices (part of GxP) audit frameworks that apply to pharmaceutical operations, its trends and expectations, and familiarity with other Good Practice concepts and global regulations.
  • Strong verbal and written communication, including presentation skills.
  • Strong project management skills.
  • Ability to influence and lead cross-functional teams.
  • Permanent work authorization in the United States.

Nice To Haves

  • Extensive pharmaceutical industry experience in operational risk, compliance management, and hands-on roles in Quality Operations (QO), Operations, Validation, and Quality Control (QC).
  • A solid technical and practical understanding of various dosage forms.
  • Strong analytical and problem-solving skills.
  • Experience using common AI tools, including generative technologies such as ChatGPT or 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.
  • Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Responsibilities

  • Develop and lead complex projects, while ensuring quality and inspection readiness.
  • Provide leadership and mentoring of vendor operations colleagues.
  • Responsible for Qualification and Oversight activities for a variety of vendors.
  • Approve external investigations, CAPAs, change controls, Quality Agreements, to maintain compliance with vendor operations.
  • Collaborate with PharmSci colleagues and business lines to develop procedures that increase efficiency and maintain high-quality standards.
  • Represent Vendor Operations Quality as a subject matter expert at cross-functional forums and projects, supporting global manufacturing sites and regulatory operations.
  • Provide clear, direct, and timely communication to stakeholders, driving customer relationships, delivering quality improvement recommendations, and implementing continuous improvement initiatives.

Benefits

  • Relocation assistance may be available based on business needs and/or eligibility.
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