AD GMP QA / AD GMP QA

AD GMP QA, CMC Operations - Permanent

Location: Newark, California

Lead quality with confidence and shape the future of innovative therapies while ensuring the highest standards of GMP compliance. Proclinical is seeking an Associate Director of GMP Quality Assurance to support CMC operations in California. This position involves close collaboration with cross-functional teams to maintain product quality, patient safety, and supply continuity.

Primary Responsibilities

• Lead and manage quality assurance activities related to GMP manufacturing, providing guidance on regulatory requirements and ensuring compliance with GMP standards.

Skills & Requirements

• Bachelor's degree in a scientific or related discipline; advanced degree preferred.
• Extensive experience in the biotech or pharmaceutical industry, with a focus on Quality Assurance.
• Expertise in preparing for and hosting regulatory inspections and audits.
• Strong knowledge of FDA, EU, and ICH regulations and guidance documents.
• Proficient in organization, prioritization, and time management, with the ability to handle multiple priorities.
• Excellent oral and written communication skills.
• Demonstrated ability to work effectively in cross-functional teams.
• Strong attention to detail and a commitment to quality.
• Proficiency in commonly used productivity software.

Key Responsibilities

• Act as the Quality Lead for assigned CMC programs, overseeing GMP API manufacturing.
• Provide QA oversight for GMP manufacturing and analytical operations.
• Review and approve Master Batch Records (MBRs), change controls, and product specifications to ensure compliance with cGMP requirements and regulatory expectations.
• Oversee external analytical laboratories, ensuring compliance with cGMP and ICH guidelines for method lifecycle activities, including qualification, verification, and validation.
• Review and approve laboratory investigations, deviations, and corrective/preventative actions (CAPAs) conducted by external labs.
• Collaborate with cross-functional teams to assess and mitigate quality risks impacting product quality and patient safety.
• Review and approve manufacturing records, deviations, investigations, and CAPAs to support timely product dispositions.
• Ensure completeness and compliance of executed batch records and supporting documentation for lot disposition.
• Support regulatory inspections, internal audits, and vendor qualifications, including performing QA GMP vendor audits and writing audit reports.
• Monitor GMP vendor progress in addressing audit findings and provide recommendations.
• Review and approve stability protocols and reports to ensure scientific integrity and compliance with regulatory expectations.
• Investigate and manage product complaints, recalls, and stock recovery processes as needed.
• Stay updated on FDA, EU, and ICH regulations and advise on their impact on GMP activities.
• Travel up to 25%, including international travel, as required.

Compensation

$200,000.00 - $225,000.00 Per Annum

If you are interested in applying for this exciting opportunity, please apply online using the form below. Please note that only applications matching the job profile will be considered.

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