Director, Supplier Quality Management

Why Patients Need You
Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need when they need them.

What You Will Achieve

The Director, Supplier Quality Management reporting to the VP, Quality Systems and Operations Compliance, is responsible for enabling Supplier Quality Management aligned with regulatory expectations for PGS internal sites, External Supply, Global Supply Chain and Environment, Health and Safety. The Director, Supplier Quality Management interfaces with cross-functional business process owners and may serve as the sponsor for projects associated with continuous improvement of supplier quality processes.

This role is responsible for oversight, and for assuring compliance of projects, products and programs with Pfizer Policies, Quality Standards, Standard Operating Procedures (SOPs), and all applicable worldwide regulations and guidelines (e.g. US FDA, EU Directives and global PGS programs).

This role will work in strong partnership with Sourcing and Enterprise Services and other groups such as Pharmaceutical Sciences and PGS New Product Launch, to deploy a transformed global process leading to an efficient and compliant end-to-end Supplier Management process across the lifecycle of Supplier Qualification and Management. The transformation will result in ensuring that the appropriate teams are delivering timely and effective communication of relevant metrics, trends and actions, performed in a compliant manner both at the local and global level. This colleague is responsible for deploying appropriate quality business processes pertaining to supplier selection, onboarding, qualification and ongoing oversight activities. 

The Director, Supplier Quality Management will also be responsible for partnering closely with Sourcing and Enterprise Services on all relevant processes including Quality Agreements, communicating Supplier changes, changes in supplier regulatory / compliance status to sites/functional groups. This colleague will also collaborate with the Risk Management team to deploy cross-functional risk assessment processes in support of major/critical non-conformances and change controls and draft risk assessment reports in conjunction with user sites.

The role will partner with Digital Quality to administer systems and programs that drive standardization of practices across all GMP functions delivering efficient & effective processes, enhanced compliance and agility that integrates and automates people, process, data and technology activities. The Director, Supplier Quality Management will be responsible for monitoring the health of the global processes through key metrics and will ensure a continuous improvement feedback loop to sustain robust processes and systems are in place.

How You Will Achieve It

• Leads project teams of matrixed colleagues with responsibility for deploying processes and systems governing Supplier Quality Management.

• Authors, reviews, and approves relevant global policies and procedures.

• Ensures processes are in place for the network to follow standard processes, monitor metrics for trends and reporting via Management Review and Risk Review processes.

• Works with the Training team to develop and deliver Supplier Quality Management training.

• Works closely with sites, local supplier quality teams and the supplier audit teams to:

  • Build feedback loops for continuous improvement based on current GMP requirements and expectations.

  • Promote a culture of quality and operational excellence.

• Maintains knowledge of current regulatory changes and industry trends and translates new requirements back to the company’s policies and procedures.

• Represents the Quality Systems and Operations Compliance organization on relevant governance committees as needed.

• Actively develops and contributes to network initiatives.

Qualifications

Must Have

• Bachelor’s degree

• A minimum of 10 years’ experience n the pharmaceutical industry or related areas with strong knowledge of quality and manufacturing operations

• Prior experience (5+ years) leading or transforming Supplier Quality Management.

• Current knowledge of relevant regulations (Eg. 21 CFR Part 210,  211, 820, Eudralex, PICs, ICH, MDD, MDR, ISO 13485, etc.)

• Demonstrated ability to lead complex projects and cross-functional processes, to estab