Inspection Management Lead Director

  • Company: Pfizer
  • Location: New Jersey, United States
  • Posted: December 08, 2017
  • Reference ID: 1611401

The Inspection Management Lead Director supports Pfizer as required by 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 Lead Director coordinates Pfizer responses to such inspections. The Inspection Management Lead Director may also provide support for other MQA activities in the region including, but not limited to quality investigations, external stakeholder engagement, and Quality Management System support. ROLE RESPONSIBILITIES In order of importance, indicate the primary responsibilities critical to the performance of the role. It is recommended not to list actual tasks but focus on 5-8 essential responsibilities that highlight accountability and level of judgment required. Leadership: Serves as a member of the Inspection Management group setting operational MQA strategies, policies and direction for Inspection Management Champions MQA mission and strategies throughout the MQA organization and among customers for efficient delivery of MQA and compliance activities Collaborates with business stakeholders to drive a culture of regulatory compliance and ensures effective and efficient management of inspection activities Serves as a strategic leader/partner to quality/compliance/inspection readiness colleagues for inspection-related activities 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) Works with MQA functional lines and key customers to understand stakeholder needs Risk/Quality Management 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 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 Operational Excellence: Collaborates with other MQA Inspection Management 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 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 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 inspected parties regarding the completion of inspection corrective and preventative action plans (CAPAs) Leads 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 and presents periodic summary reports related to Pfizer inspections to MQA leadership and stakeholders Ensures that global contact lists, report distribution lists, and tracking lists used for inspection-related activities are updated and maintained Partners with other IM Leads to identify 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 Inputs inspection information and reports into appropriate MQA repositories and tools 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 Fosters a work climate/culture within the team that exemplifies the Pfizer Values Takes accountability to e communicate relevant and timely information to the MQA LT, other MQA functions and stakeholders QUALIFICATIONS Indicate qualifications that are job related, consistent with business necessity and necessary for the performance of an essential function of this role including: education/licenses/certifications, relevant experience (where legally permissible), technical and/or other job-related skills. Bachelor's degree or equivalent experience is required. Advanced academic qualification/degree is preferred; equivalent relevant professional experience will be considered Required: At least 10 years of relevant experience in clinical or pharmacovigilance QA, or other clinical quality management/QC role in biomedical science, clinical development, regulatory compliance Fluency in the English language (written and verbal) is a requirement for this position Preferred: Prior experience in organizations or with applications for continuous improvement or metrics trending highly desirable Ability to function autonomously in a matrix model and in a team environment Project management experience with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities a plus 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. 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.

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