Associate Director of Quality Assurance, Operations

About the role

The QA Associate Director oversees the Quality Assurance department, focusing on clinical manufacturing and warehouse activities, including raw materials and drug products disposition.

Responsibilities

• Leads and mentors Quality Assurance personnel
• Recruits, interviews, hires, and trains new staff
• Oversees daily workflow of the department
• Leads and implements continuous improvement initiatives to reduce risk and improve efficiency for the company's quality systems and department operations
• Manages and schedules department operations
• Oversees and conducts review and approval of Investigations, CAPAs, Complaints, and Change Management
• Reviews and approves SOPs, batch records, raw material records, and certificates of conformance/compliance
• Ensures cGMP compliance systems and processes are in place to support raw material and drug product review, release, storage, and shipping
• Defines and maintains a strong people management, training, and engagement culture to ensure a high and constantly improving right first-time rate
• Supports internal audits, client audits, and regulatory inspections

Requirements

• Results-driven and broad-minded quality assurance professional with extensive experience in compliance and regulations, quality systems management, investigations, training and mentoring, client relations, performance management, and change management
• Extensive experience with direct or quality oversite of manufacturing operations

Skills and Experience

• Expert knowledge of GMP guidelines and Quality expectations for preclinical and clinical phase manufacturing operations
• In-depth understanding and application of cGMP principles, concepts, practices, and standards
• Ability to influence diverse stakeholders and drive accountability and decision-making cross-functionally
• Demonstrated ability to partner with other functional groups to achieve business objectives
• Time and project management skills with the ability to multi-task and meet deadlines
• Excellent verbal and written communication skills
• Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside of the company
• Excellent organizational skills and attention to detail
• Strong analytical and problem-solving skills
• Strong supervisory and leadership skills

Education and Experience

• Minimum of a bachelor’s degree, preferably in a scientific discipline. An advanced degree is preferred
• 10+ years previous GMP and Quality experience in the Pharmaceutical industry with quality oversite of Oral Solid Dose manufacturing
• Experience with regulatory inspections by the FDA and EU authorities