Veterans Preferred - Director, Vendor Program Lead

  • Pfizer
  • 60 Lispenard St, New York, NY 10013, USA
  • Nov 09, 2020

Job Description

Military Veterans are Encouraged to Apply. ROLE SUMMARY Science is the foundation of all that we do at Pfizer. We are seeking a Director, Vendor Program Lead, who will join a diverse team of dedicated professionals driven to significantly improve the lives of patients through his/her/their work at acompany whose culture is committed to developing and nurturing diverse talent so that each colleague has the opportunity to build a fulfilling career. Regulatory Quality Assurance (RQA) is an independent Quality audit function within the Compliance division, accountable to identify risks and non-compliance associated with Pfizer's GxP regulated operations. The Director, Vendor Program Lead is responsible for the design, execution and governance of the risk assessment process across all PV, GCP and GLP vendors. This role is responsible for ensuring the completeness of the Vendor Audit Universe and determining the audit schedule in partnership with the GCP and PV Vendor leads, as well as leading and conducting vendor audits. This role is responsible for Good Clinical Practice (GCP) and/or Pharmacovigilance (PV) oversight of Vendors and ensuring vendor practices are aligned with Pfizer expectations, Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US FDA, EU Directives, ICH, and National regulations), as applicable. ROLE RESPONSIBILITIES Responsible for the design, execution and governance of the risk assessment process across all PV, GCP and GLP vendors Ensures completeness and documentation of the Vendor Audit Universe and determining the audit schedule in partnership with the GCP and PV Vendor leads; Works in partnership with GCP and PV leads to gather all required elements from Business Process Owners with vendor oversight responsibilities in order to complete the risk assessment Assesses compliance of Vendors against applicable government agency GCP, GLP, GCLP, Regulatory and Pharmacovigilance regulations and guidelines as well as Pfizer policies and procedures Leads and conducts complex and non-routine audits including process audits Assesses audit plans and quality metrics to identify potential areas of risk Ensures audit outcomes are calibrated and driven to completion, ensures issues are escalated, and ensures holistic remediation plans and sustainability of CAPA Advises business representatives (e.g. BPOs or Senior Leaders) on outcomes of complex audits and provides input to process improvement activities Is a member of the functional leadership team and works with the other members to help benchmark against other audit groups and continuously improve audit processes Leads/Participates on cross RQA and cross functional project teams and shares knowledge and best practices with relevant groups Engages key stakeholders in assuring risk factors are identified and communicated during all phases of the audit process Keeps current with emerging program/regional/country specific regulatory and inspection trends and informs/advises/participates in the audit intelligence gathering process; active participant in industry forums Ensures all audits are conducted in compliance with Pfizer policies, Standards and RQA procedures Demonstrates robust experience in Quality Assurance/Auditing Leads process improvement progression Monitors and maintains expertise in processes or programs Interfaces with regulatory authorities on assigned programs and represents Pfizer at industry forums Acts as a leader in RQA by continuously improving audit practices, sharing knowledge with counterparts and ensuring colleagues are adequately skilled and trained to meet the needs of the business Coaches and mentors colleagues including providing training across all audit types and Due Diligence assessments Challenges, develops and provides feedback on key risks to RQA leadership and business process owners/program owners on a consistent basis Serves as an expert within his/her knowledge area or region and keeps up to date on current industry trends Maintains strong relationships with relevant stakeholders by understanding and contributing to their quality goals SME within multiple disciplines/specific vendor programs (e.g. labs, data management, etc.); Experience designing and conducting risk assessments preferred Expert of at least one area of ICH GCP, GLP, GCLP, EMA Pharmacovigilance Directives and applicable global regulations 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. BS (or equivalent), preferably in pharmaceutical or natural sciences, or equivalent Demonstrates refined critical thinking capabilities (e.g. Analyzes key information, questions, and problems clearly and precisely, evaluates material with insight, uses inference to reason from given information to important implications and consequences, uses deductive reasoning consistently and with ease) Defines continuous improvement strategy and operational improvement opportunities to remove roadblocks Ability to identify risks and need for escalation Experience evaluating and understanding quality standards or their applications Ability to communicate and influence at Senior Director or VP level Has SME capabilities and can represent Pfizer in industry conferences and with stakeholders Able to identify correct path for stakeholder engagement Able to use technology to recognize and interpret business trends Provides coaching and mentoring to team members PREFERRED QUALIFICATIONS Master's or advanced degree preferred 10+ years relevant experience (robust experience in auditing or quality management) Experience leading audit teams in a matrix environment Experience growing and developing talent Measures performance of group and holds team accountable for internal KPIs NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS The travel requirement may be up to 20% Last Date to Apply for Job: November 22, 2020 Employee Referral Bonus Eligible #LI-PFE 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. 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. Quality Assurance and Control
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