Associate Director, Quality Assurance
3 weeks ago
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-STARs Quality System for the manufacture, testing, and release of APIs and intermediates in accord with cGMP regulations and related FDA/ICH guidelines.
Maintain J-STARs 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 MicrosoftOfficeand other job-related software and applications.
Reporting Relationship
Reports to the Director of Quality Assurance
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