Manager, Vendor Operations Quality

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
In this role, you will:
Manage GMP or GDP external vendors and contracted services in support of clinical supply and new product development through the lifecycle of the vendor.
Responsible for new vendor qualification including:

• Partner with business lines on selection process, assisting with due diligence when required.
• Completing risk assessments with business lines and vendors to mitigate any risk before qualification risk
• Develop qualification strategy by working with business line stakeholders to understand timelines
• Lead and or contribute to the generation, maintenance and approval of quality agreements

Responsible for all aspects of vendor oversight inclusive of:

• Site visits and quality review meetings
• Generation of oversight plans
• Periodic evaluation of performance and determination of qualification status
• Monitoring Vendor Performance
• Maintaining Vendor information in all GMP systems
• Lead exit strategy with partner lines if determination to exit a vendor
• Lead and guide moderately complex projects, managing time and resources effectively, and apply skills and discipline knowledge to departmental work.
• Make decisions to resolve moderately complex problems, develop new options guided by policies, and operate independently in ambiguous situations
• Manage vendor deviations, change control providing insight and approval when needed
• Identify areas for improvement, and facilitate agreements between different teams using leadership skills
• Assess supplier operations for quality compliance, conduct quality reviews, and report results to relevant business lines and quality groups
• Participate in internal cGMP audits, support regulatory inspections, and communicate with internal and external customers to resolve vendor related issues
• Ensure effective internal networking to develop and maintain business partner relationships with internal colleagues

Here Is What You Need (Minimum Requirements)

• Applicant must have a high school diploma (or equivalent) and 10 years of relevant experience; OR an as associate's degree with 8 years of experience; OR a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience.
• Substantial experience in pharmaceutical manufacturing and quality control
• Familiarity with Current Good Manufacturing Practices (cGMP) and handling compliance issues arising from cGMP deviations or product defects
• Knowledge of regulations related to vendor management programs and other industry quality systems
• Strong critical thinking skills and a proactive approach
• Ability to collaborate effectively, manage relationships, and communicate well both in writing and verbally
• Advanced computer skills in MS Office applications and a good understanding of enterprise systems such as SMS, eQMS, QTS, GDMS, CLM.

Bonus Points If You Have (Preferred Requirements)

• Experience in Quality Systems in pharmaceutical, medical device, or combination product industry
• Knowledge or exposure to data science
• Strong leadership and team management skills
• Ability to work under pressure and meet tight deadlines
• Ability to influence and negotiate with stakeholders
• Experience in conducting internal audits and supporting regulatory inspections

PHYSICAL/MENTAL REQUIREMENTS
Mental agility to handle strategic decision-making across different divisions of the organization (i.e., in collaboration with Quality Site leaders across the network, Portfolio Leads, including above site leaders).
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
• Schedule is 1st shift, Monday - Friday.
• • Ability to flex work schedule, when required, to meet the needs of the global organization
Work Location Assignment: Hybrid
OTHER JOB DETAILS

• Last Date to Apply for Job: May 12, 2025
• Referral Bonus Eligibility: YES
• Eligible for Relocation Package: NO

The annual base salary for this position ranges from $112,700.00 to $187,800.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
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.
Quality Assurance and Control