Small Molecule Manufacturing Quality Manager — GMP

Otsuka Pharmaceutical Co., Ltd; United States; Remote; USD 108,000 - 161,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k) match

Paid holidays

Paid leave

Job summary

Otsuka Pharmaceutical Co., Ltd in the United States is seeking a Manager, Manufacturing Product Quality (Small molecule) to ensure GMP compliance across manufacturing, packaging, labeling, and distribution of products. Lead cross-functional teams and oversee external vendors to maintain regulatory standards and product integrity throughout clinical and commercial supply chains.

The role covers batch release, QC oversight, CAPA, change control, and APQR preparation, with focus on training and

Qualifications

• Bachelor’s degree in Chemistry, Engineering, Life Sciences, or a related field.
• Minimum 5 plus years of experience in a regulated industry (pharmaceutical or medical device), with 3–5 years in Quality Assurance or Supplier Quality roles.
• Familiarity with FDA 21 CFR Parts 210, 211, 820, and Part 11 requirements.

Responsibilities

• Oversee manufacturing of commercial and clinical products at contract manufacturers to ensure compliance with GMP and applicable global regulatory requirements.
• Performs batch record review and quality release activities of assigned commercial and clinical products (API, drug product, and final finished product).
• In collaboration with the supplier quality team, support qualification and monitoring of external contract manufacturing vendors, including audits and performance reviews.
• Review and approve GMP documentation including batch records, labels, and packaging specifications.
• Ensure proper implementation of manufacturing, packaging and labeling requirements for commercial products and investigational products across global clinical trials.
• Provides quality oversight for QC- related activities including review and approval of release/stability data, method development and validation, testing protocols/reports, method transfers and testing activities.
• Collaborate with Commercial and Clinical Supply Chain and Regulatory Affairs to ensure timely and compliant delivery of clinical materials.
• Support deviation investigations, CAPA implementation, and change control related to manufacturing activities.
• Maintain and update SOPs, work instructions, and quality documentation related to manufacturing and packaging processes
• Collaborates with cross functional teams to prepare of the Annual Product Quality Review (APQR) for commercial products.
• Provide training and guidance to internal teams and external partners on quality requirements.
• Participate in periodic reviews of quality systems and contribute to improvement initiatives.
• Prepare and contribute to quality metrics and reports for management review.

Skills

Bachelor's degree in Chemistry, LifeSc

5+ years in regulated industry

QA / Supplier Quality

FDA 21 CFR Parts 210, 211, 820, Part 1

MS Word, Excel, Access

TrackWise

Travel up to 20%

Education

Bachelor's degree in Chemistry, Engineering, Life Sciences, or related field

Tools

TrackWise

Job description

Otsuka Pharmaceutical Co., Ltd in the United States is seeking a Manager, Manufacturing Product Quality (Small molecule) to ensure GMP compliance across manufacturing, packaging, labeling, and distribution of products. Lead cross-functional teams and oversee external vendors to maintain regulatory standards and product integrity throughout clinical and commercial supply chains.

The role covers batch release, QC oversight, CAPA, change control, and APQR preparation, with focus on training and