Pfizer Inspection Management Team Lead in New York, New York
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
The Inspection Management Team Lead (IM TL) supports Pfizer by (as required) preparing for, organizing and leading Good Clinical Practice (GCP) and Pharmacovigilance (PV) inspections (sponsor, investigator site, vendor, as appropriate) conducted by global Health Authorities/Regulatory Authorities (HAs/RAs), and pharmacovigilance audits conducted by license partners, as appropriate. In addition, the Inspection Management Team Lead coordinates Pfizer responses to such inspections. The IM TL acts as the business and functional partner on cross functional issues and drives the team to consistently and effectively execute on the strategy across all inspections. This individual will also act as a Medial Quality Assurance sponsor/lead in cross-functional projects. This role leads and develops a team of high performing Inspection Management Leads and ensures that quality standards are consistently applied across all inspections. This individual helps guide, develop, and mentor Inspection Management Leads to help facilitate the growth of talent. The Team Lead is knowledgeable with current regulatory/health authority trends, and brings a unique understanding/perspective relative to regulatory/compliance investigations.
• Serves as a member of the Inspection Management group setting operational MQA strategies, policies and direction for Inspection Management
• Champions an understanding of MQA mission and strategies throughout the MQA organization and among customers for efficient delivery of MQA and compliance activities.
• Collaborates with business stakeholders to instill a culture of regulatory compliance and ensures effective and efficient management of inspection activities.
• Acts as a strategic leader in Quality, influencing leadership, peers, and reports within MQA and leadership and peers across functional lines, to develop a consistent and transparent Inspection Management Quality strategy.
• Drives team excellence by initiating and investing in development to build a stronger and more capable organization. Responsible for performance management. Strengthens group business acumen by providing opportunities to analyze and solve strategic business issues. Provides appropriate ongoing support to ensure that current talent develops the skills necessary to be a high performing MQA professional
• Partners with other MQA Inspection Management Leads, Portfolio Team Leads, PCO Regional Team Leads, and quality/compliance/inspection readiness colleagues in the BUs/RUs/Platform Lines for activities related to inspection preparation. Activities include but are not limited to preparation of relevant materials and conducting inspection-related training (e.g., inspection interview technique).
• Leads pre-inspection visits of investigator sites
• Leads and/or supports management of global HA/RA inspections (GCP/GPvP, as appropriate) and ensures that roles and responsibilities have been defined and assigned for each inspection. Assumes a leadership role or other supportive roles during the inspection, as required
• Works with members of the inspection team and other colleagues (including, but not limited to, Head of Inspection Management, Head of MQA and Legal) to ensure optimum responses are provided to address and resolve inspection findings
• Provides guidance to parties regarding the completion of inspection corrective and preventative action plans (CAPAs)
• Coordinates and assists in the preparation, conduct and management of mock inspections, as appropriate
• Develops and maintains policies, standard operating procedures (SOPs), tools, and guidelines (as appropriate) for preparation and conduct of inspections within Pfizer
• Prepares periodic summary reports related to Pfizer inspections
• Serves as a consultant to quality/compliance/inspection readiness colleagues for inspection-related activities
• Ensures that global contact lists, report distribution lists, and tracking lists used for inspection-related activities are updated and maintained
• Assists in identifying needs for updates to training materials, inspection readiness modules and documents required for the inspection readiness program
• Maintains high level of expertise in international GCP/GPvP regulatory requirements, and policies, SOPs and project-specific procedures within Pfizer applicable to the clinical trial methodology and pharmacovigilance processes
• Monitors trends in health authority inspection activities to proactively identify potential areas of risk for Pfizer
• Represents Pfizer in external meetings and conferences as required
• Inputs inspection information and reports into appropriate MQA repositories and tools
• Liaises with relevant SOP and Training groups to promote continuous quality/process improvements based on inspection observations
• Evaluates inspection reports from various sources (e.g., HAs/RAs, other Pfizer quality groups) to identify issues of potential significance
• Interfaces with functional groups within MQA and customers to build knowledge of GCP/PV regulations and guidelines, and routinely engages in influencing the external environment through appropriate MQA activities (e.g. review of guidelines)
• Engages in and supports the activities of the relevant MQA initiatives (as appropriate) to ensure alignment in interpretation and dissemination of applicable regulations, guidance, and Pfizer policies and procedures to customers and stakeholders
• Works with MQA functional lines and key customers to understand stakeholder needs
• Works to ensure that quality standards are consistently applied across inspections
• Provides support and mentorship to direct reports to ensure that inspection activities are consistently executed and quality standards are maintained across MQA
• Provides current, direct, complete and actionable positive and corrective feedback to others, clearly assigns responsibility for tasks and decisions, sets clear objectives and measures, monitors process, progress and results, designs feedback loops into work
• Grow others by providing challenging and stretching tasks and assignments, is aware of each direct reports career goals, mutually constructs compelling development plans and executes them, pushes people to accept developmental moves, will take on those who need help and further development
• Undertakes leadership to provide appropriate support and guidance to the inspection team. Motivates the team through deliverable / goal-setting, ongoing feedback and formal evaluation
• Works with QA LT peers, relevant line leaders and local heads, to ensure appropriate staff allocation for impending inspections
• Provides leadership and direction to the Inspection Management colleagues through appropriate education, mentoring, and training
• Bachelor's degree or equivalent experience is required. Advanced academic qualification/degree is preferred; experience working in a Pharmaceutical industry managing GCP, PV inspections will be highly considered.
• At least 15 years of relevant experience in clinical or pharmacovigilance QA, or other clinical quality management/QC role in biomedical science, clinical development, regulatory compliance
• Demonstrated knowledge of ICH GCP, PV, and clinical research regulatory landscape, and of the principles of quality assurance.
• Demonstrated knowledge of the inspection / inspectorate requirements globally
• Fluency in the English language (written and verbal) is a requirement for this position
• Prior coaching experience as a people manager
• Proven ability to function autonomously in a matrix model and in a team environment
• 5+ years in a management role with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities
• Prior experience working as a healthcare inspector/regulator for GCP, PV.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Travel Required 30%
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.
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Additional Offer Details:
Last Date to Apply for Job: July 26, 2017
Additional Location Information : Primary Location is New York, NY; Consideration given to: Groton, CT; Peapack, NJ; Walton Oaks, UK; Sandwich, UK
Eligible for Employee Referral Bonus
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.