Job Description

The client is seeking a Director, Project QA Compliance (PERM) to support and strengthen GMP quality programs with strong visibility and influence across commercial and clinical manufacturing. This role will implement and communicate quality strategies, policies, and programs; promote recognition of quality initiatives among internal and external customers; and provide hands-on direction to ensure consistent application of cGMP, QSR, and relevant regulatory guidance across operations and contract manufacturing sites. Key responsibilities include directing QA activities and oversight of multiple functional areas, ensuring quality of products through batch record review, product release support, labeling artwork review and approval, label issuance, and authorship and maintenance of Quality Agreements and Annual Product Reviews. The Director will oversee manufacturing and materials management QA support; manage QA change control and documentation; organize internal investigations with complete records; and supervise product complaints and quality metrics. The role will also oversee batch review and disposition, collaborate with internal teams and external stakeholders to resolve quality issues, and coordinate internal and external audit readiness and follow-up. The Director will manage inspections and audits conducted by regulatory authorities and marketing partners, including follow-up responses, and oversee quality-related communications such as field alerts, recalls, or regulatory actions. The role typically requires at least 10 years of experience in commercial GMP operations and at least 5 years in GMP Quality with experience that may include product leadership and contract manufacturing oversight, along with demonstrated skills in continuous process improvement and quality management systems. Preferred qualifications may include experience with PAI preparation and readiness planning, as well as stability monitoring of injectable drugs and oral solid dose; an appropriate science background and relevant quality management training are expected, and strong written and oral communication skills are required.

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