Senior Manager, GMP Quality Control

Sumitomo Pharma Co. , Ltd. is a global pharmaceutical company based in Japan with key operations in the U. S. (Sumitomo Pharma America, Inc. ), Canada (Sumitomo Pharma Canada, Inc. ) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U. S. , Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website / us. sumitomo-pharma. com (/c212. net/c/link/?t=0&l=en&o=4190475-1&h=3440496098&u=https%3A%2F%2F us. sumitomo-pharma. com%2F&a=https%3A%2F%2F us. sumitomo-pharma. com+) or follow us on LinkedIn (/c212. net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2F linkedin. com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) .

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.

• Participates, as needed, in audits of contract laboratory sites and support annual Risk Assessments as part of the Supplier Quality program.

• Participates in the creation and management of Quality Agreements for contract laboratories.

• Other duties as needed.

Key Core Competencies

• Quality leader and quality culture promoter within the global organization.

• Ability to establish and maintain a positive working relationship within Sumitomo Pharma America (SMPA) and with their external business partners as it relates to area of responsibility.

• Excellent verbal and written communication skills, including ability to interact effectively with senior management and partners.

• Self-motivated, flexible, and able to prioritize work and handle multiple assignments in a fast-paced environment, while maintaining a high level of quality and compliance.

• Strategic and tactical in the planning and execution of quality initiatives and activities.

• Leader who values and demonstrates collaboration and teamwork.

• Advanced knowledge and use of software applications, including LC chromatographic analyses, statistical applications, and quality management systems (e. g. Veeva).

Education and Experience

• 8+ years of experience required, with relevant experience in biotech or pharmaceutical industry with most experience in a Quality role.

• Minimum of Bachelor's degree in a scientific discipline (e. g. , biology, chemistry, engineering, pharmacy) or relevant field of study. Master's degree preferred.

• Experience working in more than one product area (e. g. solid oral dose, injectables, combination products), and therapeutic area (e. g. oncology, urology, regenerative medicine) within Quality Control a plus.

• Advanced knowledge of GMP manufacturing and/or market release of pharmaceutical dosage forms and/or combination products desired.

• Advanced knowledge of global regulations including FDA, EMA, MHRA and PMDA guidelines and have a proven track record in implementing these guidelines in fast growing environments.

• Experience in evolving GMP related quality systems, policies, and procedures to ensure compliance with evolving standards as well as improving the efficiency of related workflows.

• Well versed in analytical and characteriza.