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Asset Quality Lead
3 months ago
Driving Level One quality for assets within one or multiple Oncology Franchise / tumor types by maintaining 'quality' line-of-sight for assets/protocols within the Pfizer Oncology clinical portfolio.
With this focus, the Asset Quality Lead (AQL) role brings deep knowledge of Level One quality issues and risk areas within assets and across clinical trial programs . In partnership with the appropriate roles in Clinical Development & Operations, the AQL will work with Clinical Study Team Quality Leads within their assets to ensure asset and study level quality oversight, drive quality risk management activities across an asset, and will be instrumental in ensuring that asset and study level information is appropriately incorporated within the GCP QMS .
They will be the initial escalation point for stakeholders and asset teams for asset and study quality risk management, quality issues management and general GCP guidance.
ROLE RESPONSIBILITIES
Level 1 GCP Quality :
IQMP (Integrated Quality Management Plan) Development and Oversight at disease area and program level including integration within the Quality Management System (QMS ), and ensuring individual asset and study level IQMPs are in place.
Escalation, Communication, and Governance - work within the Pfizer QMS framework, and in collaboration with PRD Quality, to ensure quality issues are escalated from study-level Asset Quality Leads and addressed appropriately. Represent their disease area / sub-portfolio within Pfizer Oncology Quality governance processes / meetings.
Inspection Readiness and Preparation, CAPA management - work within the Pfizer QMS framework, and in collaboration with PRD Quality to ensure inspection readiness and management of CAPAs.
Other Responsibilities:
Provide single point of accountability to clinical teams in their tumor type(s) for GCP advice and guidance.
Strategically utilize quality and compliance data to monitor portfolio quality and recognize potential risks and issues. Ensure project teams are aware of risks, issues and general quality state of asset/study. Analyze and interpret data from multiple sources to drive quality assessments.
Partner with Pfizer Oncology Clinical Development and Operations Analytics and Reporting and PRD Quality on the development and capture of quality metrics.
Provide Level 1 portfolio quality expertise on SQE investigation teams, as needed.
Design and execute Quality Compliance Assessments (QCA) within assets or CD&O process area and drive learnings across their tumor type(s).
Lead Level 1 quality review/assessment during Due Diligence and/or Integration activities.
Oversee program and study-level quality risk management activities (including IQMP activity) in their tumor type(s).
Drive consistent implementation of IQMP across program and study teams.
Facilitate IQMP development.
Assess QTL implementation by ensuring that quality metrics are monitored and that quality deviations are identified and addressed in a timely and appropriate manner .
Utilize QMS information, and integrate findings back into QMS, share learnings across assets and across Oncology Quality team.
Provide feedback to IQMP BPO to continuously improve IQMP approach.
Develop and present quality point of view at governance meetings.
Guide asset/study team on appropriate escalation pathways for quality concerns.
Advocate for study teams' continuous improvement feedback on business processes to BPOs.
Communicate key quality information (e.g., inspection/audit learnings) across asset/study teams and serve as asset quality expert) in their tumor type(s).
Provide Study Team Inspection Readiness (IR) guidance and support; lead teams through pre-submission IR deep-dive in partnership with Audit and Inspection Quality.
Participate and guide teams with inspection preparation, conduct and response activities.
Support teams during inspections.
BASIC QUALIFICATIONS
A scientific or technical degree is preferred. In general, candidates for this job would have the following levels of experience:
Bachelors - 14 years or equivalent
MS/MBA - 12 years or equivalent
PhD/PharmD/MD - 9 years or equivalent
Extensive knowledge of ICH GCP and regulations in order to assess GCP situations and coordinate resolution activities across partner lines.
Expert knowledge, experience and expertise in clinical trial development, and operational quality management disciplines such as, quality and compliance assessments, quality assurance, CAPA management, deviation management, root cause analysis, audit and regulatory inspection process, and/or inspection readiness.
Ability to build strong network/knowledge/relationships with internal/external stakeholders.
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 mea ningful outcomes and create business impact .
PREFERRED QUALIFICATIONS
Skilled in project management.
Strong interpersonal skills, ability to influence, and ability to build and maintain excellent working relationships across lines in a matrix organization.
Experience of working on global initiatives or project teams. Appreciation of diverse needs of different regulatory requirements of different sites and countries.
Ability to lead cross-line global initiatives or root cause analysis for quality related process improvement.
Ability to implement strategies using coordinated and transparent metrics to track and manage compliance.
Spotfire and Excel skills/experience .
Other Job Details:
This is an individual contributor role
This role reports into the Sr. Director
The annual base salary for this position ranges from $149,200.00 to $248,600.00. 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
