Why Patients Need You

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

You will be a member of Pfizer's dedicated and highly effective quality assurance and control team. The product lead in Quality Control (QC) Portfolio Management team is responsible for overseeing and coordinating the QC activities for assigned product(s). This role ensures that the QC activities align with organizational priorities, regulatory standards and compliance requirements. This role works closely with cross-functional teams including R&D, QA, manufacturing and regulatory affairs to ensure proper QC oversight as products are transferred from Pfizer R&D sites and implemented and maintained at the Sanford site.

• Develop and implement strategies to effectively oversee QC activities for the assigned product(s), ensuring alignment with business goals and regulatory compliance.
• Monitor performance of the assigned product(s) and provide regular updates to senior management on challenges and opportunities for improvement.
• Coordinate with cross- functional teams to ensure QC projects are delivered on-time, within budget and to quality standards.
• Assess resource requirements, training requirements, and equipment needs for the assigned program, and coordinate with laboratory management to allocate resources accordingly.
• Collaborate with colleagues and subject matter experts to determine the most suitable analytical methodologies to support project initiatives, including the use of computational predictive tools, modeling software, and data visualization tools as necessary.
• Prepare technical reports, critically review data, and evaluate new instrumentation and analytical techniques/approaches as required.
• Independently analyze experimental data and provide conclusive insights.
• Act as the primary point of contact from QC for the assigned product(s), ensuring transparent communication with stakeholders and communicating to the various QC groups the program needs.
• Develop and maintain strong relationships with internal teams, including quality assurance, regulatory affairs and manufacturing.
• Prepare and review necessary regulatory responses.
• Prepare and review QC APRR sections for assigned programs.
• Prepare and deliver presentations on assigned product(s) in various inter-departmental forums.
• Mentor junior employees and offer technical guidance when required.

• Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an associates degree with 8 years of experience OR a bachelors with at least 5 years of experience OR Masters Degree with more than 3 years of experience, OR a PhD with 0+ years of experience.
• Extensive hands-on experience and strong background in either Chemistry, Microbiology or molecular biology assays.
• Experience with troubleshooting assays and improving method performance.
• Strong technical writing and presentation skills.
• Strong communication skills at multiple levels of management.

• Experience with method validation and method transfer skills to manufacturing site.
• Experience with manufacturing process development.
• Understanding of critical quality attributes of drug substance and drug product.
• Experience in project management in a regulated environment.
• Proficiency in project management tools and quality management systems.