Pfizer

Director – External Supply Operations Quality, I&I, Rare Disease

Pfizer

full-time

Posted on:

Location Type: Hybrid

Location: Dublin • Ireland

Visit company website

Explore more

✨ AI Apply
Apply

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.
  • Demonstrated ability to resolve conflicts.
  • Advanced computer skills for MSOffice and enterprise systems such as 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
  • Flexible work location (global, site or remote based)

Applicant Tracking System Keywords

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

Hard skills
Quality AssuranceQuality ControlGMPGDPCAPADMAIC6sigmatechnical writingproject managementbatch certification
Soft skills
interpersonal skillsleadershipcommunicationinfluencing skillsconflict resolutionteamworkorganizational skillsplanning skillsproactive attitudecultural sensitivity
Certifications
Bachelor of Science DegreePost graduate science-based qualificationsclinical licensespecials license