Sumitomo Pharma America, Inc. · 3 hours ago
Senior Manager, GMP Quality Control
United States
Full-time
Remote
Senior Level, Lead/Staff
$129K/yr - $161K/yr
8+ years exp
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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.
Qualification
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Required
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.
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 characterization procedures for biopharmaceuticals and small molecules including HPLC, GC, MS, electrophoresis, immunoassays, bioburden, endotoxin, moisture, assay, and dissolution testing.
Expertise in design of method validation, transfer, and stability studies consistent with regulatory, quality, and pharmaceutical best practices (e.g., USP, ICH).
Experience with managing external CMO and contract laboratory environments.
Strong ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations.
Preferred
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.
Experience desired with drug delivery devices, diagnostics, biomarker, and genetic testing.
Experience desired in conducting product release activities for clinical and commercial drug substances and drug products; including review and approval of Master Batch Records, Executed Batch Records, batch release, and stability testing documentation, and batch disposition.
Benefits
Merit-based salary increases
Short incentive plan participation
Eligibility for our 401(k) plan
Medical, dental, vision, life and disability insurances
Unlimited paid time off
11 paid holidays
Additional time off for a shut-down period during the last week of December
80 hours of paid sick time upon hire and each year thereafter
Company
Sumitomo Pharma America, Inc.
Sumitomo Pharma America (SMPA) is a science-based, technology-driven biopharmaceutical company focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need in oncology, urology, women’s health, rare disease, cell and gene therapies and psychiatry and neurology.
1001-5000 employees
H1B Sponsorship
Sumitomo Pharma America, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (5)
Funding
Current Stage
Late StageLeadership Team
Adele Gulfo
Chief Executive Officer, Biopharma Commercial
Myrtle Potter
President and Chief Executive Officer, Sumitomo Pharma America
Company data provided by crunchbase
