Senior Manager, GMP Quality Control

Senior Manager, GMP Quality Control

Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women’s health, rare disease, and cell & gene therapies. The company’s diverse portfolio includes several marketed products and a robust pipeline of early- to late-stage assets. Building on Sumitomo Pharma’s 125-year legacy of innovation, SMPA leverages proprietary in-house technology platforms and advanced analytics capabilities to accelerate discovery, development, and help bring novel therapies to patients sooner. SMPA is a Sumitomo Pharma company. For more information, visit Sumitomo-pharma.com.

Job Overview

The Senior Manager of GMP Quality Control oversees GMP compliance of manufacturing, testing, specifications, stability and release activities for SMPA, its partners, contract testing laboratories, and suppliers of drug substances and drug products used for investigational clinical trials and/or commercial phases. The Senior Manager ensures compliance with GMPs, SMPA procedures and applicable global Regulatory guidelines by providing oversight and management of the global contract testing laboratories in partnership with the Company’s CMC Team. The Senior Manager also participates in drafting and reviewing CMC sections of the IND, IMPD and BLA/NDA submissions. In this role, the Senior Manager interfaces with internal stakeholders and external partners to ensure released drug supply within expiry date is available to support commercial product and clinical program needs.

Job Duties and Responsibilities

• Represents QC on cross-functional project teams.
• Provides quality management oversight of analytical activities with domestic and international contract manufacturing organizations and testing laboratories, and with internal and external partners.
• Reviews and approves test results conducted at contract manufacturing and testing sites for SMPA products. 
• Reviews and approves stability program protocols, test results, trend analyses, reports, and recommends product expiry extensions/reductions, as applicable. Presents at the Stability and Specification Review Committees for GMP Drug Substance and Drug Product programs.
• Reviews and approves Quality Events, Investigations, CAPA, Change Controls, and Complaints in eQMS.
• Leads OOS, OOT, and analytical quality events in eQMS. Provides guidance to internal and external partners on Phase 1b investigations to ensure investigations are conducted according to SMPA requirements, Quality Agreements, and regulatory expectations. Reviews and approves test plans and ensures timely investigation and closure of OOS/OOT.
• For CMOs with aseptic processing, reviews media fills, and environmental monitoring data as it relates to lot release, change control and facility re-starts.
• Partners with CMC to conduct method transfers and validation of new or existing analytical methods for release and stability testing of drug substance, drug product and other materials, to domestic and international contract manufacturing organizations and testing laboratories.
• Contributes to product development by making recommendations for manufacturing controls, sampling and testing to ensure product quality and compliance with GMPs from development through commercialization.
• Supports partner relationships where the same drug product testing and stability may be shared across global programs and the company’s external partners, to sustain global uniformity of analytical methods across labs.
• Coordinates the extension of expiry dates and communicates changes to contract manufacturing organizations, testing laboratories, clinical sites and regulatory affairs as needed.
• Responsible for compliance with regulatory filings and therefore must have experience in a Quality Assurance and/or Quality Control function for marketed pharmaceutical products or clinical trial materials. Authors and/or reviews regulatory IND, IMPD, CTD and BLA/NDA CMC sections. Performs QC check for regulatory submissions to ensure accuracy and data integrity. 
• Enhance quality control practices and optimize internal processes by contributing to the preparation, review and approval of standard procedures and electronic systems.
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