Director Team Leader ESOQ Specialty Care

ROLE DESCRIPTION
External Supply Operations Quality (ESOQ) is responsible for the Quality oversight and management of approximately 400 contract manufacturers, contract testing sites, packagers, suppliers and supply partners globally. As part of the ESOQ Tier 3 structure, the Quality Operations Lead has responsibility for the effective Quality Assurance Operational Management oversight of Pfizer contractors who manufacture and/or package pharmaceutical products and/or devices on behalf of Pfizer Global Supply. This role is globally focused with partners in multiple geographic locations. The Quality Operations Lead is responsible for assuring product quality of goods or services on behalf of Pfizer and shall have ultimate responsibility for Pfizer lot disposition decisions. Some regional specific roles may have region specific responsibilities.

Responsible for:

• 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 APIs, 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.

Additional Responsibilities:

• 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 CMOs/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.

• QUALIFICATIONS / SKILLS

  • 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