Manager - External Supply Quality

External Supply Quality (ESQ) is responsible for the Quality management of approximately 300 contract manufacturers, packagers, and supply partners globally. The Manager 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. This role is globally focused with partners and suppliers in multiple geographic locations.

The ESQ Manager is accountable for providing quality assurance management of key contractors / suppliers for Pfizer and for assuring that the products supplied to our patients are manufactured, tested in accordance with c-GMPs, the registration file and any additional country specific requirements.

This is highly independent position operating with mínimal supervision, interacting with high levels of management both at contract manufacturers / suppliers and within Pfizer.

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

POSITION RESPONSIBILITIES

Provide effective Quality Leadership for our vendor managed products including supporting the cross functional virtual site operating teams (VSOT) where they exist.

Successfully lead the implementation and support of Quality Assurance /Quality Control systems for Global Pharmaceutical products, API’s / RSM’s and medical devices operated by the Contract partner.

Develop and negotiate quality agreements.

Develop and negotiate Technical agreements with receiving sites.

Drive the development, implementation and continuous improvement of Quality Systems to support regulatory requirements.

Proactively support regulatory inspections at vendors and ensure appropriate Pfizer review/approval of responses to Regulatory Agencies including tracking of Corrective and Preventative actions (CAPA).

Provide Quality Leadership (including leader standard work) for notification to management and significant deviations 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.

Prepare AQRT summaries and participate in relevant meetings.

Lead quality risk management activities and manage mitigation plans within partners and suppliers.

Accountable for the on time disposition of commercial products in line with agreed schedule.

Provide Quality leadership for customer complaint or deviation investigations and track CAPAs accordingly.

ORGANIZATIONAL RELATIONSHIPS

Reporting to Sr. Manager, Team leader.

ESQ Manager will operate as spokesperson for ESQ and will spend a significant period of time developing relationships, independently negotiating, developing and communicating Pfizer quality requirements with contract manufacturers / suppliers. The ESQ Manager will have significant interactions with many internal business and manufacturing organizations (e.g., ES, GCMC, GTS, QO Center, PGS sites and PGRD) and will lead virtually based cross functional teams.

EDUCATION

Bachelor’s degree in Pharmacy / Chemistry / Biochemistry / Microbiology or other related science degree.

EXPERIENCE

Minimally 8 years in a GXP setting.

At least 4 years of Product Quality Assurance experience in a GMP environment

Experience with external suppliers/contractors is preferred

Advanced computer skills, MS Office and enterprise systems such as SAP, QTS, Documentum platforms

Command of English and Chinese language required and multi-lingual is beneficial.

Strong verbal and written communication including presentation skills

Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor.

Shows strong negotiation skills and is diplomatic in communication with internal and external customers

Demonstrated ability to manage multiple projects

Demonstrated ability to prioritize work, to act and work independently and to report items as required to Team leader

Has excellent organization skills

Developing personal leadership to manage cross functional projects

Developing ability to resolve conflicts

Takes initiatives and is proactive, persistent

Has a broad GMP and technical know-how to handle emerging issues

Fully complete Covid-19 vaccination and could provide official medical certificate

Work Location Assignment: Flexible

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control

LI-PFE