Senior Issue Lead

Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science-driven, risk-based quality culture is both flexible and innovative, always putting the customer first. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contributions have a direct impact on patient care.

Your leadership will ensure that our clinical practices meet the highest standards, directly impacting the quality and efficacy of the treatments we provide. Role Summary The Senior Issue Lead will be accountable for Quality Events: managing confirmed Major / Critical Quality Event (QE) cases through the investigation process including root cause analysis.

The Senior Issue Lead will ensure the investigations are conducted thoroughly, within required timelines and to compliance requirements including ensuring the adequacy of root cause analysis and appropriateness of communication regarding the case.

The Senior Issue Lead will direct the QE team in proposing appropriate Corrective and Preventative Actions and that completion of all those are evidenced in documentation as required.

The Senior Issue Lead will be assigned to and manage Critical and other complex cases and especially those that require presentation to senior leaders as part of the Quality Review Team (QRT) Audits and Inspection Coordination: Drive GCP quality in withstanding regulatory scrutiny, operational data and documentation.

Major areas of focus will include: Audit coordination for GCP related process and preferred CRO vendor audits CAPA management Directing Inspection readiness and providing inspection support for GCP sponsor inspection activities What You Will Achieve Quality Event Investigation The Senior Issue Lead will ensure that each confirmed case is investigated appropriately including ensuring investigation timelines are met and that appropriate pre-work is done on the case to enable a meaningful investigation with appropriate quality outcomes which includes a case summary which meets defined quality standards and can be used for a regulatory inspection.

The Senior Issue Lead will perform quality review and approval of select quality events which have been managed by other investigation leads. He/she will be assigned to process improvement initiatives and special projects as necessary and be expected to drive changes to the business process for case management when the need arises.

Training and Technology This individual will also be required to mentor and train Issue Leads to ensure the individuals reviewing the submitted issues are qualified to assess and categorize the submitted Quality Events.

Audit and Inspection Coordination This individual may be assigned additional focus areas in audit coordination or inspection coordination, including inspection responsibilities around: Directing asset/study team colleagues within CD&O/Clinical to ensure successful inspection and audit outcomes Communicating audit and inspection progress and needs to CS&O/Clinical stakeholders Serving as the point of contact for Regulatory Quality Assurance related to audit and inspection CAPA management Quality Compliance Assessment Plan, lead and report out on Quality and Compliance Assessments related to CD&O processes Root Cause Analysis This individual will also be required to apply a root cause methodology and/or due diligence approach to assigned QEs.

This individual may lead QE cases from start to finish.

Here Is What You Need (Minimum Requirements) BA/BS with at least 10 years of experience or MBA/MS with at least 9 years of experience Minimum of 5 years of pharmaceutical experience with solid experience in data management, operational aspects, GCP Quality, GxP Quality, and/or regulatory Regulatory inspection experience Process and system management experience Detailed knowledge of clinical trial processes and relationships required Knowledge of GCP requirements and applicable SOPs and regulations Project management, administrative, and technical capabilities are required, as well as effective verbal and written communication skills Strong background in continuous improvement methodology (i.e., Lean Six Sigma) preferred Bonus Points If You Have (Preferred Requirements) A Master’s degree with relevant pharmaceutical experience Strong scientific background in Life Sciences Expertise in Regulatory Affairs Proven ability to influence leadership, peers, and reports acrossfunctional lines Experience in developing and maintaining quality programs Strong analytical skills to identify and communicate issues, opportunities, and/or threats Excellent collaboration skills with management to resolve issues Ability to manage multiple projects and set strategic direction Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.

Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use ​ 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 N/A NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS N/A Relocation support available Work Location Assignment: Hybrid The annual base salary for this position ranges from $162,900.00 to $271,500.00.

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.

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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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 . Quality Assurance and Control