QC Product Lead (1st shift)
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Job Description
Use Your Power for Purpose
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.
The resource will report to the Senior Manager, QC-Portfolio Management.
What You Will Achieve
In this role, you will:
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.
Here Is What You Need (Minimum Requirements)
Applicant must have a Bachelor’s degree with at least 4 years of experience, preferably in GMP, OR Master’s degree with more than 2 years of experience, preferably in GMP, OR a PhD with 0 years of experience OR ssociate’s degree with 8 years of experience preferably in GMP OR High School Diploma (or Equivalent) and 10 years of relevant experience preferably in GMP.
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.
Bonus Points If You Have (Preferred Requirements)
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.
Analytical and strategic thinking.
Strong organizational and prioritization skills.
Excellent leadership and communication skills, with the ability to influence cross-functional teams.
Ability to work in a fast-paced, dynamic environment.
Non-Standard work schedule, travel or environment requirements
This role is designed to be 100% on-site Monday to Friday 8am – 5pm.
Other job details
Last day to apply: June 16th, 2025
No relocation support available
Work Location Assignment: On Premise
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.