• ROLE SUMMARY

  External Supply Operations Quality (ESOQ) is responsible for the Quality management of approximately 400 contract manufacturers, packagers, and supply partners globally. The Director  / Team Leader, Primary Care - Internal Medicines has responsibility for the effective Quality Assurance Management oversight of Pfizer partners and suppliers who manufacture or package Pharmaceutical products and/or devices on behalf of PGS Internal Medicines Business Unit. This role is primarily focused on North American/ Puerto Rico contract partners.

  The ESOQ Director / Team Leader are accountable for product quality made on behalf of Pfizer and shall have ultimate responsibility for Pfizer lot disposition decisions. The Director / Team Leader shall demonstrate a confidence and maturity in operating within a risk based environment and in compliance with current Good Manufacturing Practices’.

  This is highly independent position, operating with minimal supervision and interacting with all levels of management both at contract partners and within Pfizer. 

  POSITION RESPONSIBILITIES

  • Provide Quality Leadership within the cross functional virtual site operating teams (VSOT) and virtual site leadership team (VSLT). To effectively collaborate with Procurement partners to manage suppliers.
  • Successfully lead and promote the growth and development of manager /senior manager level colleagues. Ensure that colleagues are supported in accordance with Pfizer PX policies and procedures.  
  • Successfully lead the development, implementation and support of Quality Assurance /Quality Control systems for API’s, Global Pharmaceutical products and medical devices operated by the Contract partner.
  • Partner with colleagues to develop and negotiate quality agreements.
  • Drive the development, implementation and continuous improvement of Pfizer products, processes, and quality systems.
  • Proactively support 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 at contractor/partner sites that may impact compliance status or require regulatory notifications. Follow leader standard work for notification to management.
  • Ensure implementation of effective CAPA and quality system improvements based upon determined remediation activities.
  • Prepare AQRT summaries and participate 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.
  • Provide Quality leadership for customer complaint investigations and manage the relationship with the Pfizer PQC group and associated Pfizer sites.

  ORGANIZATIONAL RELATIONSHIPS

  Reporting to ESOQ Primary Care Category Leader and leading a team of manager level/ senior manager level colleagues within ESOQ, the Director T/L will have strong business line connections to both External Supply and Procurement functions and along with significant interactions with many internal business and manufacturing organizations .

  The Director / Team Leader will also operate as spokesperson for Pfizer ESOQ and will spend a significant period of time developing external relationships, independently negotiating issues, developing and communicating Pfizer quality requirements with contract manufacturer’s,.

  RESOURCES MANAGED  

    Financial Accountability

  • Accountable for reviewing and approving colleague expenses and for ensuring costs are managed within budget expectations.

    Supervision

  • Director / Team Leader will have direct line management responsibility for approx. 7 – 9 (seven to nine) Manager / Senior Manager level colleagues.

  EDUCATION

  • Bachelor’s degree in Pharmacy / Chemistry / Biochemistry / Microbiology / Engineering or other related science degree.
  • Post graduate science based qualifications preferred.

  EXPERIENCE

  • 10+ years post graduate experience within the pharmaceutical industry with proven success in leading teams. Experience in managing virtual teams preferred. Being an excellent team leader with demonstrated communication and influencing skills, the Director / Team Leader shall have the ability to interact effectively across all functions and at all levels with contract partners, including demonstrating a cultural sensitivity to ensure effective relationships are built and sustained.
  • Demonstrated ability to manage complex quality and compliance activities related to pharmaceutical products at a manufacturing plant or with a contractor. Ability to effectively manage multiple projects, prioritize work for self and others and accomplish tasks through effective team working.
  • Have a detailed knowledge of the manufacture and packaging (primary and secondary) of drug substance manufacturing, solid oral dose pharmaceutical products. Possess an in-depth knowledge of quality system regulations including a demonstrated ability to evaluate and apply global GMP’s to build effective Manufacturing/QA/QC systems.

   
  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.

  NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  Flexibility with respect to travel is required (approx. 15-30%).

  Work Location Assignment: North America Remote

 
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.

PHYSICAL/MENTAL REQUIREMENTS

Ability to perform mathematical calculations and ability to perform complex data analysis.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

10-30% travel required.

Work Location Assignment: Remote

Relocation assistance may be available based on business needs and/or eligibility.

Quality Assurance and Control