Manager, External Quality Operations

Quality Assurance and Control

Use Your Power for Purpose

Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions are crucial and will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a real difference in the lives of those who rely on our products.

What You Will Achieve

In this role, you will :

Manage all aspects related to product quality or compliance for a portfolio of external contract manufacturers and suppliers that supply materials / products to Pfizer according to established procedures.

Assess the quality of external supplier's products, processes and related documents while ensuring the product specifications are met and quality systems are maintained.

Support internal and external partners with auditing activities related to ESOQ activities, or activities at a portfolio of contractors - (RQA audits or regulatory inspections) as applicable

Support internal and external partners with Compliance Assessments to ensure current GMP / GDP adherence

Manage Risk at Vendors implementing Quality Improvement Plans and support Risk assessments, QRTs and QANs as necessary

Support onboarding activities of new CMO's or product launches within the portfolio as applicable.

Support offboarding activities for exiting CMO's / products / SKUs within the portfolio as applicable

Make product Quality decisions leveraging comprehensive knowledge of Quality / Manufacturing principles, prior work experience and concepts in other technical areas while ensuring compliance to global regulatory and Pfizer requirements.

Influence quality decision making in line with industry and Pfizer requirements

Provide Quality Leadership within the cross functional virtual site operating teams (VSOT).

Partner with colleagues to develop and negotiate quality agreements.

Review and approve Annual Product Review and Product Quality Review (APR / PQR) reports and relevant product stability reports.

Perform batch disposition endorsement.

May Identify, develop and implement continuous improvement initiatives related to ESOQ processes to ensure compliance with the latest internal and external standards.

Ensure the adequate tracking and documentation of all required quality related actions in the relevant system(s) and that all required escalation processes are followed.

Lead and support complex investigations, market complaints, risk assessments in support of products within your portfolio. Raise NTMs and connect with SMEs where needed.

Support Global Logistics and Network Services team to ensure GDP oversight is maintained during manufacture and shipping of medicinal product.

Provide Performance Metrics for key performance indicators.

Work independently, receive instructions primarily on unusual or complex problems.

Build, maintain and develop relationships with key stakeholders, both internal and external to Pfizer.

Support ESOQ leadership in other tasks as required.

Here Is What You Need (Minimum Requirements)

Applicant must have 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; OR an associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience

Experience with external suppliers / contractors.

Advanced computer skills for MSOffice and enterprise systems such SAP, QTS, Vault, Documentum platforms, Minitab

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

Takes initiatives and is proactive, persistent

Good organizing and planning skills and a high sense of urgency

Demonstrated ability to act and work independently and to report items as required to line manager

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

Demonstrated technical know how

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

Experience on managing investigations (DMAIC, 6sigma, ...)

Bonus Points If You Have (Preferred Requirements)

A solid understanding of device and combination product industry regulations

Strong analytical and problem-solving skills

Ability to work independently and make decisions

Excellent organizational and time management skills

Experience in interfacing with regulatory agencies during audits

Ability to drive continuous improvement initiatives

Physical / Mental Requirements

The position requires office job involving use of computer and to collaborate with stakeholders based in different locations and time zones.

Non-Standard Work Schedule, Travel or Environment Requirements

Up to 20% travel at CMO premises can be required.

Work Location Assignment : On Premise

The annual base salary for this position ranges from $96,300.00 to $160,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% 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.

Pfizer endeavors to make www.pfizer.com / careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and / or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and / or interviewing. Requests for any other reason will not be returned.