Director, Computer System Quality Team Lead

Pfizer Inc; Collegeville (PA); Hybrid; USD 177.000 - 294.000; Vollzeit

Benefits dieser Stelle

401(k) with Pfizer matching

Health benefits

Paid vacation

Parental/maternity leave

Zusammenfassung

Pfizer in the United States (Collegeville, PA) seeks a Director, Computer System Quality Lead to drive strategic assurance for GMP/GDP computer systems across sites. You will lead risk-based strategies, act as Quality authority for Digital processes, and guide cross-functional teams through audits, inspections, and regulatory expectations.

The role emphasizes innovation with AI, automation, and continuous monitoring, ensuring patient and data integrity while maintaining inspection readiness.

Qualifikationen

• Significant experience in computerized-system quality, Computer System Assurance or computerized-system validation within GMP/GDP or similar regulated environment.
• Demonstrated expertise in risk-based assurance, validation, and quality-risk management.
• Experience leading cross-functional initiatives in a global, matrixed organization.

Aufgaben

• Define risk-based Computer System Assurance strategies across sites and Digital organizations.
• Serve as Quality authority for Digital process framework.
• Lead portfolio-level audit and inspection readiness across Pfizer Quality units.
• Provide strategic leadership for validation and ongoing management of GMP/GDP digital systems.
• Represent quality during regulatory inspections and internal audits.

Kenntnisse

risk-based assurance

computer system quality

regulatory inspections

leadership

Ausbildung

Bachelor’s degree in science/engineering/technology/data/quality

Master’s degree in relevant field

Doctoral degree in related discipline

Tools

GAMP 5

ICH Q9

21 CFR Part 11

EU Annex 11

Jobbeschreibung

Director, Computer System Quality Team Lead### Director, Computer System Quality Team LeadApply: United States - Pennsylvania - Collegeville: United States - Any Pfizer Site: Full time: Posted Today: 4966322**ROLE SUMMARY**The Director, Computer System Quality Lead provides strategic and subject-matter leadership for Computer System Assurance and the quality oversight of GMP/GDP computer systems across PGS sites and Digital organizations. The role establishes and advances consistent, risk-based assurance practices for enterprise Digital, artificial intelligence and federated solutions, ensuring systems remain appropriately controlled, monitored, compliant and inspection-ready throughout their life cycle. Serving as the Quality authority for the Digital process framework, the Director applies deep functional expertise and independent judgment to complex system risk assessments, classifications, assurance strategies and compliance matters. The role partners with Pfizer business Quality units to promote alignment, resolve differing interpretations and support consistent application of the framework across organizational boundaries. Working across Quality, Digital, sites and business functions, the Director leads complex cross-functional initiatives and advises senior leaders on assurance, compliance risk, regulatory expectations and inspection readiness. The role advances innovative and technology-enabled approaches, including artificial intelligence, automation and continuous monitoring, to simplify Computer System Assurance while maintaining appropriate patient, product-quality and data-integrity protections.**ROLE RESPONSIBILITIES*** Define and advance risk-based Computer System Assurance strategies and practices across PGS sites and Digital organizations.* Serve as the Quality authority for the Digital process framework, promoting consistent interpretation and application across Pfizer business Quality units.* Provide authoritative quality decisions and recommendations for complex enterprise-system risk assessments, classifications and assurance approaches.* Establish quality oversight for the validation and ongoing management of GMP/GDP enterprise Digital, artificial intelligence and federated solutions.* Provide strategic leadership for the Level 2 Computer System Assurance process, including governance, maintenance, adoption, continuous improvement, process-change management, metrics and inspection support.* Lead portfolio-level audit and inspection readiness, identify systemic risks and recommend corrective or preventive actions.* Provide subject-matter leadership for significant computerized-system investigations, compliance risks and escalations.* Represent computerized-system quality matters during regulatory inspections, internal audits and senior governance forums.* Monitor evolving regulatory expectations and industry practices and translate their implications into practical quality strategies, standards and controls.* Identify and advance opportunities to simplify Computer System Assurance through artificial intelligence, automation and other Digital capabilities.* Define risk-based approaches for continuous system-health monitoring and periodic review.* Provide strategic oversight for the enhancement, adoption and value realization of Computer System Assurance and EDES.* Monitor Computer System Assurance network health and recommend improvements to governance, capability and execution.* Lead related IMEx reporting, resource visibility, risk assessment and escalation.* Partner with Business System Owners, Global Process Owners, Digital, artificial intelligence teams, portfolio management, Governance, Risk and Compliance, and other stakeholders to align assurance practices with business and portfolio priorities.* Provide strategic support to and deputize for the Computer System Assurance Global Process Owner, as appropriate.**BASIC QUALIFICATIONS*** Bachelor’s degree in a scientific, engineering, technology, data, quality or related discipline with at least eight years of relevant experience; or a master’s degree with at least seven years of relevant experience; or a doctoral degree with at least five years of relevant experience.* Significant experience in computerized-system quality, Computer System Assurance or computerized-system validation within a GMP/GDP or similarly regulated environment.* Demonstrated expertise in risk-based assurance, validation, quality-risk management and the ongoing management of regulated computer systems.* Experience providing subject-matter leadership for a significant quality process, including process maintenance, adoption, continuous improvement and inspection support.* Demonstrated experience leading complex, cross-functional initiatives in a global, highly matrixed organization.* Experience representing Quality during regulatory inspections, internal audits or inspection-readiness activities.* Demonstrated ability to exercise independent judgment and develop defensible recommendations for complex and ambiguous quality or compliance matters.* Proven ability to influence senior leaders and align Quality, Digital, site and business stakeholders without direct authority.* Strong written and verbal communication skills, including the ability to translate technical assurance matters into clear quality, risk and business implications.**PREFERRED QUALIFICATIONS*** Advanced degree in a scientific, engineering, technology, data, regulatory or quality discipline.* Quality, auditing, risk-management, Digital or computerized-system assurance certification.* Experience providing Quality authority or strategic guidance across multiple business units, sites or Digital portfolios.* Experience applying GAMP 5, ICH Q9, EU Annex 11, 21 CFR Part 11 and other relevant computerized-system requirements and guidance.* Experience addressing assurance considerations for artificial intelligence, automation, cloud-based or federated Digital solutions.* Experience establishing system-monitoring, periodic-review or inspection-readiness practices at portfolio scale.* Experience applying IMEx, Lean, Six Sigma or comparable continuous-improvement methods.* Experience using data, monitoring tools or automation to improve assurance effectiveness and efficiency.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.**PHYSICAL/MENTAL REQUIREMENTS*** Ability to evaluate multiple complex and concurrent inputs, exercise sound judgment and develop clear, actionable recommendations.* Ability to manage competing priorities and operate effectively in a complex, matrixed and globally distributed environment. **NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS*** Periodic participation in meetings outside standard working hours may be required to support global stakeholders.* Occasional business travel may be required based on portfolio and program needs.Work Location Assignment: HybridRelocation Support: NOLast date to apply: 11/12/2026The 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.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.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 [e-mail]. 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.To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.Information & Business Tech