Medical Quality Event Investigation Associate Director
Medical Quality Event Investigation Associate Director
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$ 120800 - 201400
1 Vacancy
Job Description
The Medical Quality Event Investigation Associate Director is a key member of the Medical Quality Event Issue Team within Global Medical Quality Governance (GMQG) responsible for effectively managing the coordination of US and Globalquality events and CAPAs under QMS01 Reporting and Management of Quality Events for related in scope Medical activities. This role will partner with cross-functional colleagues across the Medical organization to investigate determine root cause and develop Corrective and Preventive Action (CAPA) Plans as applicable to remediate QEs.
The position will have the following responsibilities:
- Identifying and partnering with key stakeholders to conduct in scope Medical Quality Event (QE) investigations.
- Ensuring QE investigations are completed within the established timelines using an appropriate Root Cause Gap Analysis and/or Due Diligence methodology.
- As part of the QE investigation this role will:
- Review relevant standard operating procedures (SOPs) policies and other supporting documents to determine what happened.
- Interview key stakeholders involved in the deviation.
- Facilitate the finalization of investigation documentation.
- Enter the investigation output into the electronic Quality Management System (eQMS).
- Ensure Quality Approval and Business Line Endorsement as applicable.
- Oversee completion of CAPA Plans and Effectiveness Checks (ECs) as needed.
- Adhering to QMS01 and business-related compliance requirements.
- Escalation of newly identified risks to the business and relevant business process(es) trends.
- Using all available data (i.e. audit findings historical QEs and metrics) to improve remediation activities and identify process improvements.
- Assessing assigned QE severity rating and requesting an adjustment (e.g. upgrade or downgrade) based on the outcome of the investigation.
- Collaborating with other quality functions/pillars to improve the overall QE management process.
- Providing best-practices guidance to business line quality leads in support of CAPA Plan evidence.
- Collecting evidence for the completion of CAPA Plans Effectiveness Checks (ECs).
- Support of ad-hoc quality related initiatives as required.
Qualifications
- Bachelor of Science (B.S.) degree (or equivalent) with six (6) years of commensurate experience and proven capabilities in quality event management and/or audit related matters.
- Master of Science (MS) or Master of Business Administration (MBA) with five (5) years of commensurate experience and proven capabilities in quality event management and/or audit related matters.
- Strong written and oral communication and presentation skills
- Strong interpersonal skills with demonstrated ability to influence and negotiate outcomes
- Proven leadership ability to manage multiple projects with a clear sense of priorities and respect for deadlines
- Ability and agility to perform in a team and matrix organization and adapt to a dynamic environment
- Experience in navigating a large complex matrix organization and managing stakeholders interests
- Ability to work in a fast-paced and demanding environment
- Strong organizational planning and analytical skills
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.
Work Location Assignment:Hybrid
The annual base salary for this position ranges from $120800.00 to $201400.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 17.5% 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 lifes 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 (). 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 providers 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.
Required Experience:
Director
Employment Type
Full-Time
