Director, Quality Management

ROLE SUMMARY
The Director, Quality Management will report to the Senior Director, Head of Quality Management and will collaborate with colleagues, customers, and stakeholders across the organization providing direction and strategy for all inspections involving WMS deliverables.
As the Director of Quality Management, you will lead global inspection readiness activities within WSR and liaise with quality groups outside of WMS to promote global inspection readiness. Ensure inspection readiness by applying previous inspection learnings and ensuring previous commitments have been met, including ongoing inspection and audit commitment tracking and CAPA management. Lead SQE evaluation and assessment procedures and subsequent CAPA management. Lead the evaluation of relevant WSR processes, look for opportunities for improvement and provide direction and strategy in support of inspection readiness.
ROLE RESPONSIBILITIES

• Set vision and strategy for inspection and audit readiness worldwide and provide direction through policy/procedure development and deployment, including training.
• Acts as a contact and resource for WSR globally during regulatory inspections by competent authorities including facilitating interviews with appropriate Subject Matter Experts (SMEs) and assist colleagues during the course of inspections and audits.
• Actively support PV inspections and external audits and help to make PV inspections a success, by providing effective and efficient preparation and timely turnaround of inspection requests. Supports the tracking of inspection commitments to completion ensuring timelines are met.
• Assist or lead the coordination of internal audits of WSR by assisting in the creation of the audit plan, agenda and facilitating appropriate business line SMEs.
• Assisting WSR business SMEs in appropriate audit remediation plans and tracking all actions to completion.
• Assists with/leads the preparation and communication of audit report findings including periodic trend assessments.
• Assists/generates, analyzes and reports PV scorecard to management to transparently show important aspects of the PV compliance status.
• Serves as SME and collaborates with quality groups external to WSR who will coach colleagues within CMO and country operation locations in international pharmacovigilance to prepare for internal/external audits and regulatory inspections.
• Participate in the identification of Qualifying Quality Issues, and ensure corrective/preventive action (CAPA) plans in response to Safety and Regulatory QQIs, audits, and inspections and ensure that commitments are met in a timely manner.
• Collaborates across the organization to facilitate the drafting of CAPAs in response to audits and inspections and ensures that commitments are met in a timely manner. Assesses ongoing compliance of the CAPAs submitted to regulatory agencies, identifies gaps and brings into compliance.
• Acts as the SRQ partner to facilitate progress and close CAPAs and commitments arising from regulatory inspections and internal audits, as appropriate.
• Evaluates audit/inspection reports from various sources (e.g., regulatory agencies, other company quality groups) to identify issues of significance and report trends.
• In collaboration with Standards and Training, develops and updates documents (SOPs, business procedures) relating to relevant procedures managed within SRQ.
• Partner with SRQ stakeholders to ensure consistency and inspection readiness of documents i.e. quality manual, WI prepared by SRQ.
• Participates in/facilitates a continuous improvement process to optimize the PV quality system and keep it current, based on applicable worldwide regulations.
• Facilitates/leads the development of inspection readiness tools and supports the implementation of the PV inspection readiness program.
• Serves as a consultant to business partners and contributes in building positive and value-added relationships with all stakeholders and helps these stakeholders create strategies to respond to regulatory findings and other requests from regulatory authorities.
• Maintains knowledge of current PV regulations by attending external training sessions, etc.
• Solicits feedback from customers and stakeholders to continuously improve pharmacovigilance compliance function deliverables.
• Monitors new regulatory legislation or guidelines, which have a direct impact on pharmacovigilance regulatory compliance function, and disseminates this information to members of other functional areas, where appropriate.
• Participates on/leads cross functional teams to execute process improvements identified through the audit (or inspection) process.
• Assists with efforts to drive continuous improvement efforts (quality, cost, speed, performance).

Technical Skill Requirements

• Strategic Thinking - Demonstrated ability to understand and consider competitive positioning when solving problems and making decisions.
• Clinical, Regulatory and Safety Expertise - Demonstrated knowledge of clinical research processes, safety or regulatory requirements.
• Technical Expertise - Applies technical and line knowledge of key concepts in own discipline and may act as a key technical resource within line.
• Organizational Development - Knowledge of organizational development principles and demonstrated success in developing and implementing organizational development strategies.
• Project and Process Management & Meeting Established Deadlines - Demonstrated ability to manage complex projects and cross-functional processes and to meet established deadlines. Demonstrated ability to adapt to changing situations and work well under pressure. Presentation/Influencing/Organizational Skills - Strong platform skills evident. Ability to lead by example and effectively implement strategies through influence and persuasion.
• Multitasking - Demonstrated ability to effectively work on simultaneous complex projects/deliverables.
• Team and Matrix Structure - Ability to work effectively and contribute proactively in a team-based environment as well as in partnership with colleagues, customers, and stakeholders.
• Analytical and Statistical Skills - Demonstrated analytical and statistical skills, knowledge of root cause analysis techniques a plus.
• Systems Technologies - Technical proficiency, including skills in use of common desktop tools (MS Word, MS Excel, MS Project, PowerPoint, Visio, etc.), and experience with CAPA tracking tools a plus.

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.

• Doctorate or Master's level degree preferred, or
• B.S. Degree (or equivalent) with commensurate experience in inspections, audits, Quality and compliance.
• 5-7 years minimum experience focusing on Pharmacovigilance, Regulatory Affairs or within a Health Authority.
• Extensive knowledge of the pharmaceutical industry including Pharmacovigilance and ICH compliance regulations and guidelines and expertise within the pharmacovigilance, inspection, audit, or quality and compliance arena.
• Experience in collaborating or interacting with health authorities (including but not limited to the US FDA, EMA, MHRA) or with other global regulators is highly desired.
• Demonstrated awareness of the key differences in how business is practiced in various countries to work effectively with various cultures. It is essential to be aware of the key cultural customs and practices that will create an effective working relationship with internal and external partners and effectively represent Pfizer as a multinational organization.
• Business travel up to 10-30%

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Work Location Assignment: Hybrid

Other Job Details:

• Last Date to Apply: January 12th, 2025

The annual base salary for this position ranges from $156,600.00 to $261,000.00. 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
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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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