Pfizer

Director – External Supply Operations Quality, Internal Medicine

Pfizer

full-time

Posted on:

Location Type: Hybrid

Location: Dublin • Ireland

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Job Level

Senior

Tech Stack

Vault

About the role

  • Provide Quality Leadership to support cross functional virtual site operating teams (VSOT) and virtual site leadership teams (VSLT) as appropriate
  • Successfully lead with strong interpersonal skills to promote the growth and development of manager/senior manager level colleagues
  • Ensure that colleagues are supported in accordance with Pfizer PEX policies and procedures
  • Successfully lead the development, implementation and support of Quality Assurance /Quality Control systems for API’s, Global Pharmaceutical products, Suppliers and Medical Devices operated by the Contract partner, as applicable
  • Partner with colleagues to develop and negotiate Quality Agreements
  • Partner with Global Logistics and Network Services team to ensure GDP oversight is maintained during manufacture and shipping of medicinal product as applicable
  • Drive the development, implementation and continuous improvement of Pfizer products, processes, and quality systems to ensure Pfizer remains a market leader of Pharmaceutical Product
  • Proactively support GMP/GDP regulatory inspections at vendors and ensure appropriate Pfizer review/approval of responses to Regulatory Agencies including tracking of Corrective and Preventative actions
  • Provide Quality Leadership for significant deviations or customer complaints at contractor/partner sites that may impact compliance status or require regulatory notifications
  • Ensure implementation of effective CAPA and quality system improvements based upon determined remediation activities
  • Leading generation of QRT summaries as applicable and participating in relevant meetings
  • Lead quality risk management activities and manage mitigation plans within CMO’s / suppliers
  • Accountable for the on-time disposition of commercial products in line with agreed schedule
  • Works highly independently, operating with minimal supervision and interacting with all levels of management both at contract partners and within Pfizer
  • Acts as senior technical/functional expert; provides business direction to site or business group; leverages technical/functional expertise within own business line or sub-function
  • Demonstrates extensive industry knowledge
  • Exhibits a high level of business knowledge and understanding of the external marketplace and anticipates business line or sub-function customer requirements
  • Demonstrates confidence and maturity in operating within a risk-based environment and in compliance with current Good Manufacturing Practices
  • Develops and leverages resources to implement innovative ideas/processes/products across business lines or sub-functions
  • Sets objectives for and manages multiple projects/ongoing work activities of high complexity within own business line or sub-function
  • Manages and leads people, technological and financial resources within the business line or sub-function; looking for efficiencies and managing resources outside of direct authority
  • Develops solutions to complex, ambiguous problems, often outside of own area of expertise and typically as part of a (virtual) team or leadership team
  • Is accountable for decisions within business line or sub-function
  • Leverages a variety of communication tools and techniques to help colleagues understand how their work aligns to business priorities
  • Effectively presents business issues across department or business line
  • Supporting ESOQ leadership on other tasks as required
  • If applicable, oversees oversight of external testing activities at CTO for Release and Stability testing

Requirements

  • Bachelor of Science Degree, Pharmacy, Engineering or other related science degree
  • Post graduate science-based qualifications preferred
  • Minimally 10 years’ experience in Pharmaceutical or Medical Device Quality Assurance roles with direct responsibility for product quality decisions and/or 15 years’ experience in the pharmaceutical or medical device industry
  • Significant post graduate experience within the pharmaceutical industry with proven success in leading teams and cross functional projects/initiatives
  • Experience and personal leadership to work in virtual teams preferred
  • Demonstrated communication and influencing skills to have the ability to interact effectively across all functions and at all levels of an organization, including demonstrating a cultural sensitivity to ensure effective relationships are built and sustained
  • Experience with managing external suppliers/contractors, preferred
  • Demonstrated experience in effectively managing a team
  • Demonstrated ability to manage complex quality and compliance activities related to pharmaceutical products at a manufacturing plant or with a contractor
  • Demonstrated investigation skills and knowledge of DMAIC, 6sigma, YB or GB
  • Ability to effectively manage multiple projects, prioritize work for self and others and accomplish tasks through effective teamwork
  • Advanced computer skills for MSOffice and enterprise systems such SAP, QTS/QMS, Vault, PDM, Documentum platforms, Minitab and AI tools such as CoPilot
  • Proficient in English (written and spoken)
  • Strong technical writing skills
  • Strong verbal, written communication, and presentation skills
  • Demonstrated DEI attitude
  • Demonstrated clinical and specials license know how
  • Demonstrated experience managing batch certification and importation
  • Takes initiatives and is proactive, persistent
  • Strong organizing and planning skills and a high sense of urgency
  • Have a detailed knowledge of the manufacture and packaging (primary and secondary) of drug substance manufacturing, solid oral dose pharmaceuticals and/or Aseptic / Sterile pharmaceutical products
  • Possess an in-depth knowledge of quality system regulations including a demonstrated ability to evaluate and apply global GMPs to build effective Manufacturing/QA/QC systems
  • Possess knowledge of main regulatory directives and guidelines (dossier structure, variation guideline)
Benefits
  • Health insurance
  • 401(k) matching
  • Flexible work hours
  • Paid time off
  • Remote work options

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
Quality AssuranceQuality ControlGMPGDPCAPADMAIC6sigmatechnical writingproject managementregulatory compliance
Soft skills
interpersonal skillsleadershipcommunication skillsinfluencing skillsteamworkcultural sensitivityproblem-solvingorganizational skillsplanning skillsproactivity
Certifications
Bachelor of Science DegreePost graduate science-based qualificationsclinical licensespecials license