The posting
Role Description:
External Supply Operations Quality (ESOQ) is responsible for the Quality oversight and management of approximately 400 contract manufacturers, contract testing sites, packagers, suppliers and supply partners globally.
As part of the ESOQ Tier 3 structure, Director, External Supply Operations Quality has responsibility for the effective Quality Assurance Operational Management oversight of Pfizer contractors who manufacture and/or package pharmaceutical products and/or devices on behalf of Pfizer Global Supply. This role is globally focused with partners in multiple geographic locations.
The Director, External Supply Operations Quality is responsible for assuring product quality of goods or services on behalf of Pfizer and shall have ultimate responsibility for Pfizer lot disposition decisions.
Some regional specific roles may have region specific responsibilities.
Responsible for:
- Provide Quality Leadership to support cross functional virtual site operating teams (VSOT) and virtual site leadership teams (VSLT) as appropriate.
- Successfully lead with strong interpersonal skills to promote the growth and development of manager /senior manager level colleagues. Ensure that colleagues are supported in accordance with Pfizer PEX policies and procedures.
- Successfully lead the development, implementation and support of Quality Assurance /Quality Control systems for API’s, Global Pharmaceutical products, Suppliers and Medical Devices operated by the Contract partner, as applicable.
- Partner with colleagues to develop and negotiate Quality Agreements.
- Partner with Global Logistics and Network Services team to ensure GDP oversight is maintained during manufacture and shipping of medicinal product as applicable.
- Drive the development, implementation and continuous improvement of Pfizer products, processes, and quality systems to ensure Pfizer remains a market leader of Pharmaceutical Product.
- Proactively support GMP/GDP regulatory inspections at vendors and ensure appropriate Pfizer review/approval of responses to Regulatory Agencies including tracking of Corrective and Preventative actions.
- Provide Quality Leadership for significant deviations or customer complaints at contractor/partner sites that may impact compliance status or require regulatory notifications. Ensure implementation of effective CAPA and quality system improvements based upon determined remediation activities.
- Leading generation of QRT summaries as applicable and participating in relevant meetings.
- Lead quality risk management activities and manage mitigation plans within CMO’s / suppliers.
- Accountable for the on-time disposition of commercial products in line with agreed schedule.
- Works highly independently, operating with minimal supervision and interacting with all levels of management both at contract partners and within Pfizer.
- Acts as senior technical/functional expert; provides business direction to site or business group; leverages technical/functional expertise within own business line or sub-function.
- Demonstrates extensive industry knowledge. Exhibits a high level of business knowledge and understanding of the external marketplace and anticipates business line or sub-function customer requirements.
- Demonstrates confidence and maturity in operating within a risk-based environment and in compliance with current Good Manufacturing Practices.
- Develops and leverages resources to implement innovative ideas/processes/ products across business lines or sub-functions.
- Sets objectives for and manages multiple projects/ ongoing work activities of high complexity within own business line or sub-function.
- Manages and leads people, technological and financial resources within the business line or sub-function; looking for efficiencies and managing resources outside of direct authority.
- Develops solutions to complex, ambiguous problems, often outside of own area of expertise and typically as part of a (virtual) team or leadership team. Is accountable for decisions within business line or sub-function.
- Leverages a variety of communication tools and techniques to help colleagues understand how their work aligns to business priorities.
- Effectively presents business issues across department or business line.
- Supporting ESOQ leadership on other tasks as required.
- If applicable, oversees oversight of external testing activities at CTO for Release and Stability testing.
Here Is What You Need (Minimum Requirements)
- Must have a bachelor's degree, Pharmacy, Engineering or other related science degree preferred, with at least 8 years of experience in Pharmaceutical or Medical Device Quality Assurance roles with direct responsibility for product quality decisions and /or experience in the pharmaceutical or medical device industry; OR a master's degree with at least 7 years of experience; OR a PhD with 5+ years of experience.
- Proven success in leading teams and cross functional projects/initiatives.
- Demonstrated communication and influencing skills to have the ability to interact effectively across all functions and at all levels of an organization, including demonstrating a cultural sensitivity to ensure effective relationships are built and sustained.
- Demonstrated experience in effectively managing a team, directly or indirectly.
- Demonstrated ability to manage complex quality and compliance activities related to pharmaceutical products at a manufacturing plant or with a contractor.
- Demonstrated investigation skills and knowledge of DMAIC, 6sigma, YB or GB
- Ability to effectively manage multiple projects, prioritize work for self and others and accomplish tasks through effective teamwork.
- Demonstrated ability to resolve conflicts
- Advanced computer skills for MS Office and enterprise systems such SAP, QTS/QMS, Vault, PDM, Documentum platforms, Minitab and AI tools such as CoPilot
- Proficient in English (written and spoken)
- Strong technical writing skills
- Strong verbal, written communication, and presentation skills
- Demonstrated DEI attitude
- Demonstrated clinical and specials license know how
- Demonstrated experience managing batch certification and importation
- Takes initiatives and is proactive, persistent
- Strong organizing and planning skills and a high sense of urgency.
- Have a detailed knowledge of the manufacture and packaging (primary and secondary) of drug substance manufacturing, solid oral dose pharmaceuticals and/or Aseptic / Sterile pharmaceutical products.
- Possess an in-depth knowledge of quality system regulations including a demonstrated ability to evaluate and apply global GMPs to build effective Manufacturing/QA/QC systems.
- Possess knowledge of main regulatory directives and guidelines (dossier structure, variation guideline)
- 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.
Bonus Points If You Have (Preferred Requirements)
- Knowledge of IMEx
- Post graduate science-based qualifications preferred.
- Experience and personal leadership to work in virtual teams preferred.
- Experience with managing external suppliers/contractors, preferred.
Resources Managed: Budget & FTEs
- 5-6 direct reports
- Financial Accountability - Accountable for reviewing and approving colleague expenses and for ensuring costs are managed within budget expectations.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Up to 20% travel
Work Location Assignment: Hybrid
Last date to apply: November 20, 2026
The annual base salary for this position ranges from $176,600.00 to $294,300.00.* In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% 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.
* The annual base salary for this position in Tampa, FL ranges from $158,800.00 to $264,600.00.
This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview.
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
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.
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Quality Assurance and Control
