Sign In
 [New User? Sign Up]
Mobile Version

Director Compliance


Milan, TN 38358
Apply on the Company Site
  • Save Ad
  • Email Friend
  • Print
  • Research Salary

Job Details


Collaborate with colleagues, customers, and stakeholders across the organization to actively support all inspections involving WSR processes. Conduct global inspection readiness activities within WSR and liaise with quality groups outside of WSR 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. Support SQE evaluation and assessment procedures and subsequent CAPA management. Lead or assist in evaluation of relevant WSR processes and facilitate remediation strategies in support of inspection readiness.

**Main 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 lead 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.

+ Assist WSR business SMEs in appropriate audit remediation plans and tracking all actions to completion

+ Assist with/lLeads the preparation and communication of audit report findings including periodic trend assessments.

+ Assist/generate, analyze and report PV scorecard to management to transparently show important aspects of the PV compliance status.

+ Serve 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.

+ Collaborate 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. Assesse ongoing compliance of the CAPAs submitted to regulatory agencies, identifies gaps and brings into compliance.

+ Act as the SRQ partner to facilitate progress and close CAPAs and commitments arising from regulatory inspections and internal audits, as appropriate.

+ Evaluate 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, develop and update 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

+ Participate in/facilitate a continuous improvement process to optimize the PV quality system and keep it current, based on applicable worldwide regulations.

+ Facilitate/lead the development of inspection readiness tools and support the implementation of the PV inspection readiness program.

+ Serve as a consultant to business partners and contribute in building positive and value-added relationships with all stakeholders and help these stakeholders create strategies to respond to regulatory findings and other requests from regulatory authorities.

+ Maintain knowledge of current PV regulations by attending external training sessions, etc.

+ Solicit feedback from customers and stakeholders to continuously improve pharmacovigilance compliance function deliverables.

+ Monitor new regulatory legislation or guidelines, which have a direct impact on pharmacovigilance regulatory compliance function, and disseminate this information to members of other functional areas, where appropriate.

+ Participate on/Lead cross functional teams to execute process improvements identified through the audit (or inspection) process.

+ Leads or Assists with efforts to drive continuous improvement efforts (quality, cost, speed, performance).


In general, candidates for this job would have a degree in a scientific or technical discipline with the following levels of education/experience:

+ Doctorate or Master's level degree preferred, or

+ B.S. Degree (or equivalent) with commensurate experience in inspections, audits, Quality and compliance.

+ 7-10 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.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Apply on the Company Site
Powered ByLogo

Featured Jobs[ View All ]

Featured Employers [ View All ]