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Director, Compliance CAPA/Root Cause, Trend Analyses & Reporting


New York, NY
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Job Details

The Global Investigations and Risk Assessment team is looking for a director responsible for developing and managing a centralized root cause process, trend identification, trend and remediation tracking/reporting. The role will develop a process for and perform root cause analysis on identified Compliance Investigation matters, and monitor, track and report out on programmatic remediation efforts, and proactive risk mitigation action plans. The colleague will provide strategic support to identify and analyze potential, new and emerging risks. Substantive areas include commercial, customer and business transactions, advertising and promotion, anti-kickback and fraud and abuse. The role requires significant coordination with global colleagues to address remediation and compliance efforts with the goal of enhancing and tracking compliance activities, execution of remediation plans and risk mitigation strategies across the enterprise. This role will report to Global Risk Assessment and Investigations and support the broader Global Investigations team, as well as, engage and collaborate cross-divisionally and cross-functionally. The candidate will be skilled at navigating complex matrix organizations in order to effectively communicate and coordinate with business unit and regional level compliance leads/managers to perform root cause analyses and develop/support remediation planning and execution, as well as, working with the Global Investigations team and reporting function to identify, evaluate and address trends and potential emerging issues.


+ Apply CAPA or similar formal corrective and preventive action planning methodology to develop and perform root cause analyses of investigations to inform corrective action planning and programmatic remediation.

+ Monitor remediation on reported Compliance Investigations team's findings to ensure timely and comprehensive resolution.

+ Negotiate resolutions of issues which arise during remediation, and track and report progress of remediation implementation.

+ Provide metrics for investigations trends, CAPA, complaint and audit information, and develop documentation and reporting (e.g., control and risk scorecards, KPIs and other business reporting metrics) in variety of platforms to support assessment of compliance and risk.

+ Liaise with Pfizer's Compliance Committees, Audit and Legal functions to provide supporting data and reports on activities and remediation efforts.

+ Advocate and highlight compliance requirements, best practices, standards, procedures and initiatives to support and promote compliance across the enterprise.

+ Foster strong relationships and alliances cross-functionally to attract ideas and identify new ways to approach compliance-related requirements.


+ A minimum of 7 years of significant experience in strategic consulting, risk management, legal, and/or compliance with pharmaceutical or healthcare experience preferred

+ Minimum 3 years project management experience and coordinating cross-functional teams. Experience with compliance investigations preferred.

+ BS or BA degree; Advanced degree (Masters, MBA, JD) a plus

+ Green/black Six Sigma or LEAN certification preferred

+ Functional knowledge and experience in areas of quality and/or compliance based upon practical experience, including root-cause problem solving (e.g., 8D, CAPA), quality gates, Six Sigma, CGMP regulation, remediation, and/or experience with assessments of human performance and error reduction/mitigation.

+ Understanding of healthcare-related laws and regulations and industry standard preferred, including the False Claims Act, Anti-Kickback statute, OIG regulations and guidance, pharmacovigilance issues, and the Foreign Corrupt Practices Act

+ Professional work experience in developing and implementing quality and compliance concepts

+ Experience in control management and remediation, and advising on internal policies and process

+ Ability to effectively facilitate and manage meetings and complex, strategic conversations

+ Ability to translate complex requirements to practical suggestions and real world solutions

+ Excellent communications skills and the ability to communicate complex concepts in ways that are understood and actionable by cross-function teams

+ Strong business and big picture acumen

+ Knowledge of Quality Management Systems, project management and problem resolution

+ Experience in team facilitation and root cause analysis and resolution

+ Demonstrated success negotiating the environment of a highly matrix-based organization

+ Strong presentation skills involving audiences with various backgrounds, and ability to adjust message and filter details based on audience

+ Strong skills in Microsoft Office applications, as well as, GRC system, and skills in Tableau and other data visualization software preferred

Willingness to travel (international and domestic) when needed.

**EEO Statement**

**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.

**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.

**Additional Offer Details:**

+ **Last Date to Apply for Job: October 11, 2017**

+ **Grade: 16**

+ Eligible for Employee Referral Bonus

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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