Manager, Quality Assurance Operations

PRIMARY RESPONSIBILITIES

• Developing, implementing, and maintaining processes to support QA oversight for the manufacturing of cloning material to be used in clinical studies
• Supporting the development of policies, processes, procedures, and controls ensuring that facility operations conform to established cGMP standards and regulatory requirements and guidelines
• Supporting the qualification activities associated with the implementation and release of systems, utilities, facility areas (i.e., manufacturing suites), and equipment onboarding/ maintenance for the new facility
• Supporting day-to-day QA activities associated with manufacturing of cloning materials
• Releasing manufacturing suites and batch/product changeovers for continuation of manufacturing activities
• Participating in cross-functional teams to resolve quality related issues impacting manufacturing activities
• Reviewing and approving documentation such as Manufacturing Batch Records (MBRs), product specifications, change controls, deviations and CAPAs associated with the operations at the manufacturing facility
• Evaluating and approving proposed process changes and improvements in the Manufacturing area, ensuring that appropriate risk assessments are conducted and proposed changes/improvements are consistent with applicable regulatory guidelines
• Supporting investigations associated with critical or major manufacturing deviations and providing the necessary guidance to authorize manufacturing operations, as applicable
• Authoring, reviewing, and approving internal quality documents (SOPs, investigations, etc.)
• Participating in supplier qualification audits and supporting internal audits and regulatory inspections, as needed
• Developing, trending, and reporting of relevant Quality Metrics associated with the area of responsibility
• Maintaining the QA Operations function in a state of compliance and inspection readiness

BASIC QUALIFICATIONS

• B.S./M.S. in Life Sciences or related field with 5+ years of experience, including leadership, in GMP Quality Assurance
• Experience with QA and GMP compliance in clinical biologics products
• Experience providing QA oversight to manufacturing operations in a pharmaceutical/ biotechnology environment
• Ability to assess vendor quality core processes ensuring compliance with relevant guidelines and procedures
• Experience with implementation of electronic system(s) to ensure compliance in 21CFR Part 11 and other applicable regulations
• Ability to organize and prioritize workload to meet deadlines and company objectives
• Ability to work independently and within cross-functional teams
• Knowledge of FDA/EMA/ICH regulations and guidelines regarding clinical production and supply of biopharmaceutics

LEADERSHIP QUALIFICATIONS

• Organizational, staff mentorship, and time management skills with attention to details
• Handling multiple assignments in a fast-paced environment with changing priorities
• Independent development and execution of work plans with minimal supervision
• Strong analytical problem-solving, and critical-thinking skills
• Excellent written and verbal communication skills with the ability to communicate effectively