Quality and Compliance Standards Lead

ROLE SUMMARY

The Quality Compliance Lead(s) (QCL) are key members of the Evidence Generation Team and are aligned by Therapeutic Area (TA). The QCL are responsible for supporting the quality oversight for implementation of research and studies conducted in the global Evidence Generation Platform. This role will coordinate and facilitate quality and training activities cross functionally for the BU related to Evidence Generation study activities, provide guidance to study team for ensuring correct study type and application of safety reporting rules for study type. Additional involvement in quality activities will include: audit preparedness, quality event reporting/ CAPA development and remediation, new process development & implementation and audit response.

The RWE Platform QCLs will provide quality oversight of the conduct of global epidemiological studies, collaborative research and low intervention studies (LIS) types 1&2 to support the Integrated Evidence Plans (IEP) and strategic goals of all regions including IDM and EM. All study types are within remit including PMCs, PMS, PAES and voluntary & committed PASS and epidemiological studies across the asset life cycle from POC onwards.

The QCLs will collaborate globally and cross functionally with clinical affairs, medical affairs, RWE partner/ platform, RWE Scientists and other stakeholders to ensure global consistency, governance and compliance by deploying fit for purpose training, oversight, processes/procedures and the regular update of existing SOPs to adjust for innovation and high quality evidence generation.

ROLE RESPONSIBILITIES

TA-Level Quality Oversight

Collaborate with cross-functional teams to ensure RWE plan strategy and asset-level risks are incorporated into study and asset-level quality oversight to support participant data rights, safety and the reliability of trial results.

Strategically utilize quality measures/data to monitor portfolio quality to understand and recognize potential risks, identify trends, and support state of quality reporting.

Address and triage questions pertaining to quality within Evidence Generation scope; escalates issues appropriately within the QMS structure

Communicate key quality information across asset/study teams and serve as TA quality expert.

Study-Level Quality Oversight

Provide study teams with guidance on high risk activities, by utilizing quality metrics and ensuring quality deviations are identified and addressed in a timely and appropriate manner. ·

Quality review of regulatory submission projects/ protocol drafts, to ensure studies are conducted in compliance with relevant SOPs and applicable internal, external, regulatory requirements.

Quality Oversight for study types conducted in the real world evidence generation platform including Non-Interventional, Low Interventional and Collaborative Research.

For collaborative research the QCL provides quality oversight and quality planning with the external sponsor/ partner and internal RC Manager and RC requestor to ensure all EvGen Platform proposed research collaborations are compliant with relevant internal governance and external regulations.

Audit & Inspection Readiness and Preparation

Provide Study Team with Audit & Inspection Readiness (IR) guidance and support.

Develop and maintain inspection readiness tools and processes, as appropriate for RWE Platform and in alignment with RQA/CQA.

Provide guidance and focused support to asset teams and pivotal study teams that have a high likelihood of internal audit and regulatory inspection.

Business Development/Data Use Assessment Management

Quality representative of the Evidence Generation/ RWE team for business development opportunities.

Collaboration with data partnership platform to provide strategic input to risk-based quality approaches related to data use and acquisitions, as needed.

Technology/Process Improvement

With the Clinical Affairs & Operations Team and Platform & Partnerships the Quality & Compliance pillar will work together to support the novel Enterprise tool in KIMS (and other technology platforms) for managing, measuring, reporting and documenting all work product supported by the RWE platform.

QCDs will leverage the KIMS tool (and other technology) for quality improvement, cost savings, return on investment, speed to completion, adherence to governance, alignment to priority and metrics that span every aspect of the work both quantitatively and qualitatively.

BASIC QUALIFICATIONS 

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.

 Bachelor’s Degree and 10 years of relevant clinical trial, non-interventional study and/or epidemiologic study experience. 

Masters Level degree (MPH, MS) in a health-related field such as health services research, public health, and minimum 8 years of relevant clinical trial, non-interventional study and/or epidemiologic study experience. 

In depth knowledge of ICH-GCP, research quality/compliance experience, study regulations, and data privacy requirements. 

Experience in SOP evaluation, risk assessment and quality event processing. 

Experience in audit management and CAPA writing with cross functional teams. 

Effective collaboration on virtual teams and proactive in optimizing ways of working. 

Flexibility to engage global team members and stakeholders in disparate time-zones 

Strong working knowledge of the technical and methodological aspects of registries, post-authorization safety studies, and observational study design and implementation. 

Skilled in functioning within a matrixed organization where managing through influence is required 

Excellent interpersonal skills required: ability to understand and respond to multiple internal and external customers 

Ability to influence stakeholders constructively and to minimize conflict 

Strong project management abilities are essential. 

Demonstrated ability to manage multiple projects (multitask) involving complex processes, competing deadlines and rapidly shifting priorities. 

Change oriented, comfortable responding to unexpected demands with tight timelines, team player. 

PREFERRED QUALIFICATIONS  

Proficiency in SharePoint/Teams 

Proficiency in Microsoft Office applications 

Fluent in English, both written and verbal

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS   

Approximately 10% travel may be required 

ADDITIONAL DETAILS:

Last date to apply for Job : July 31, 2024.

The annual base salary for this position ranges from $161,600.00 to $269,400.00. 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.

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#LI-PFE

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