Quality Assurance Compliance Manager

Kelly Government Solutions is seeking a highly skilled Manager of Quality Assurance with a strong foundation in CMC and early-stage (pre-IND and early clinical) compliance.

The ideal candidate will have a minimum of 5 years of experience in Quality Assurance within the pharmaceutical industry, operating under FDA regulations.

The Quality Manager will be responsible for overseeing all Quality Assurance operations, ensuring strict adherence to applicable regulations.

This role demands a collaborative individual capable of working effectively with various departments, including manufacturing, QC, CMC regulatory, and Contract Research Organizations.

Roles & Responsibilities

• Author and review essential quality documents such as procedures, specifications, and quality reports, tailoring them to specific client needs.
• Lead and participate in meetings with QA, QC, and manufacturing teams, providing regular updates to management.
• Offer QA support for facilities, utilities, and equipment, including reviewing and dispositioning out-of-tolerance records.
• Manage data integrity practices in accordance with policies, site procedures, and regulations.
• Oversee timely initiation and completion of deviations and investigations, ensuring compliance with established standards.
• Lead the initiation, evaluation, and completion of Change Controls.
• Propose and implement Corrective and Preventive Actions (CAPAs) to enhance system and process efficiency.
• Contribute to Product Quality Reviews and participate in the review and approval of PQRs.
• Support internal and external audits to verify regulatory and quality compliance.
• Collaborate with management during regulatory agency inspections and audits.
• Optimize and implement phase-appropriate quality systems for pre-clinical programs.
• Serve as a subject matter expert on quality issues and compliance for manufacturing, packaging, and distribution to CROs.
• Conduct quality audits for incoming materials and CROs.
• Ensure adherence to gowning requirements and provide on-the-floor QA oversight.
• Verify and maintain effective process control measures in product manufacturing.
• Review and approve critical documents such as Master Batch Records, forms, procedures, and test methods.
• Manage and resolve deviations, discrepancies, and change controls prior to batch release.
• Oversee timely issuance of production records, procedures, and documentation.

Qualifications & Education Requirements

• BS / MS in life sciences or a technical discipline; advanced degree in Chemistry, Biology, or equivalent preferred.
• Minimum 5 years of experience in CMC Quality Assurance within the pharmaceutical or biotech industry.
• 3+ years of supervisory or management experience.
• In-depth understanding of quality system reviews, deviations, OOS, CAPAs, and remediation plans.
• Comprehensive knowledge of CFR regulations (21CFR Part 210, 211, etc.), ICH guidelines, quality management systems, and standards.
• Proven ability to apply GMPs in accordance with U.S. standards and experience with CMC / Pharma Development teams.
• Strong understanding of the drug development lifecycle and regulatory landscape.
• Experience conducting GMP audits of manufacturing facilities and internal operations.
• Knowledge of computer systems validation methodologies.

Required Personal Skills

• Passion for contributing to the growth of a small pharmaceutical company.
• Ability to thrive in a fast-paced, dynamic environment with minimal supervision.
• Proficiency in MS Word, Excel, PowerPoint, and other relevant software.
• Excellent team building, leadership, and management skills.
• Strong interpersonal, verbal, and written communication abilities.
• Proven problem-solving and process improvement skills.
• Ability to apply risk-based and phase-appropriate quality approaches.
• Meticulous attention to detail and strong organizational skills.
24 days ago