Quality Program Manager II
DSJ Global is seeking a Quality Program Manager II to play a key role in advancing product quality and operational excellence. This individual will work closely with the Director of Quality Operations to lead continuous improvement initiatives, mitigate quality risks, and ensure compliance with internal standards and regulatory requirements. The role also involves managing client quality expectations, resolving quality issues, and supporting cross-functional collaboration to drive timely and effective outcomes.
Key Responsibilities:
- Serve as the primary quality assurance liaison for assigned clients.
- Ensure timely and thorough review of batch records prior to product release.
- Lead the investigation and closure of Deviations, CAPAs, Change Controls, and Customer Complaints.
- Collaborate with cross-functional teams to maintain high-quality standards and regulatory compliance.
- Support internal and external audits, including FDA inspections and client audits.
- Deliver project updates and quality metrics to internal and external stakeholders.
- Act as a subject matter expert on batch release and related quality issues.
- Drive continuous improvement initiatives across quality systems and processes.
- Provide training on batch record review and other quality-related topics across the site.
- Interpret and apply SOPs to ensure operational compliance.
- Maintain current training records and certifications.
- Perform additional duties as assigned by the Director of Quality Operations.
Qualifications:
- Bachelor's degree in a scientific discipline or related field.
- Minimum of 3 years of experience in a GMP-compliant, FDA-regulated pharmaceutical environment.
- At least 2 years of experience in a quality assurance role (preferred).
- Strong understanding of quality systems, regulatory requirements, and industry best practices.
- Excellent communication, problem-solving, and organizational skills.
- Ability to work effectively in a fast-paced, collaborative environment.
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