Associate Director, Quality Assurance

Prerequisites

• ≥ 7 years of experience within the pharmaceutical/biotechnology industry or CDMO industry is required.
• ≥ 3 years of experience in small molecule cGMP processing, analysis and/or release testing is required.
• ≥ 3 years of experience in process chemistry is preferred, but not required.
• BA/BS degree in chemistry, chemical engineering or pharmaceutical sciences is required.

Responsibilities

• Support J-STAR’s Quality System for the manufacture, testing, and release of APIs and intermediates in accord with cGMP regulations and related FDA/ICH guidelines.
• Maintain J-STAR’s Quality System in a manner consistent with FDA/ICH requirements for cGMP manufacture and testing for APIs in early clinical phases.
• Promote compliance with cGMP regulations. Present and coordinate GMP training sessions.
• Support management and maintenance of the SOP and Document Control system.
• Author, review, update, and approve quality documents, specifications, and procedures as needed.
• Conduct timely review and approval of batch process and analytical records. Release APIs and intermediates manufactured subject to GMP compliance.
• Provide guidance to GMP personnel and ensure that deviation and OOS investigations are adequate and completed in a timely manner.
• Ensure that change control is enforced for critical systems, procedures, and specifications.
• Audit and approve suppliers of materials and services critical to GMP activities.
• Participate in internal audits to assess GMP compliance and identify potential gaps or training needs. Develop and implement corrective actions to address observations.
• Act as secondary J-STAR contact for client audits and regulatory inspections. Track completion of post-audit action items.
• Work with clients to develop material release tests and specifications for materials supplied by JSTAR.
• Help ensure that client project needs, requirements, and timelines are communicated to, and coordinated between, cGMP Operations and Quality Control.
• Respond to client inquiries and provide information and updates as needed and appropriate to support regulatory filings.

Qualifications

• Proven track record of setting and meeting aggressive targets and timely execution of objectives.
• Excellent written, verbal and communication skills.
• Ability to prioritize and manage numerous projects simultaneously.
• Ability to interact in an effective and appropriate manner with diverse population sets.
• Ability to communicate candidly, clearly and timely.
• Experience in working on, positively contributing to, and leading teams.
• Proficient in Microsoft®Office™and other job-related software and applications.

Reporting Relationship

• Reports to the Director of Quality Assurance