Senior Quality Assurance Manager

3d3 days ago

Pfizer

Groton, US · Full-time · $124,400 – $207,400

About this role

Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. This role implements and oversees processes for Pharm Sci Small Molecule (PSSM) PTx GMP R&D pipeline programs. The position has key responsibilities for execution of the PTx Portfolio, leading to seamless lifecycle management and transfer to Pfizer Global Supply sites or Contract Manufacturing Organizations.

Lead projects with complete accountability for quality oversight of complex PSSM(PTx) projects including acquired assets, partnerships, and internal accelerated pipeline programs. Provide quality and compliance oversight for disposition of clinical trial material drug substance, API, drug product, and combination products. Many programs operate at an accelerated pace due to unmet medical need.

Work with multiple Contract Manufacturing Organizations, acquired or in-licensed companies, Pharm Sci, and Pfizer Global Supply PTx-facing sites globally. Act as PSOQ quality point of contact to project teams and establish norms for collaboration and roles and responsibilities. Influence a strong quality culture across various internal and external quality groups.

Interpret and execute against evolving compliance regulations for new focus areas and novel technologies such as multi-specifics, peptides, and nanoparticles. In collaboration with business lines and Global Regulatory Affairs, develop control and release strategies for assigned projects. Review and approve global procedures that impact quality systems and quality of clinical trial material.

Requirements

Solid understanding of compliance regulations, process validation, Quality by Design concepts, and quality systems.
Knowledge of manufacturing, testing, stability, scale-up, and development of solid and semi-solid small molecule dosage forms, diagnostics, and combination products.
Ability to meet project targets and manage complex, accelerated pipeline programs.
Experience working with Contract Manufacturing Organizations and external partners in a quality oversight capacity.
Ability to interpret and execute evolving compliance regulations for novel technologies and modalities.
Innovative use of communication tools and techniques to facilitate explaining issues and create a collaborative team environment across internal and external quality groups.
Experience with quality integration plans for acquired assets and companies.

Responsibilities

Lead projects with complete accountability for Quality oversight of complex PSSM(PTx) projects including acquired assets, partnerships, and internal pipeline programs.
Provide Quality and Compliance oversight for disposition of Clinical Trial Material drug substance, API, drug product, and combination products.
Work with multiple CMOs, acquired or in-licensed companies, Pharm Sci, and PGS PTx-facing sites to ensure quality in development and manufacturing.
Act as PSOQ quality point of contact to PSPT and CDT project teams and various sites globally.
Interpret, advise, and execute against evolving compliance regulations for new technologies and modalities.
Provide Quality oversight to external vendors, CMOs, and acquired companies responsible for manufacturing of drug substance and drug product.
Review and approve PSOQ global procedures that impact quality systems and quality of clinical trial material.

Benefits

Purpose-driven work focused on delivering safe and effective products to patients.
Flexible and innovative quality culture that is science and risk-based.
Opportunity to contribute to critical pipeline programs with accelerated timelines for unmet medical needs.
Collaboration with diverse teams across internal and external global sites.